An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT01592370
• Recruitment Status: Active, not recruiting
• First Posted: May 7, 2012
• Results First Posted: February 17, 2022
• Last Update Posted: September 13, 2023
• Sponsor: Bristol-Myers Squibb
• Collaborator: Janssen, LP
• Information provided by (Responsible Party): Bristol-Myers Squibb

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Non-Hodgkin's Lymphoma; Hodgkin Lymphoma; Multiple Myeloma
• Interventions: Biological: Nivolumab; Biological: Ipilimumab; Biological: Lirilumab; Biological: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone
• Enrollment: 316

Participant Flow

Recruitment Details	For the phase 1 nivo monotherapy dose escalation included in this study, it was derived from CA209-003. It was concluded that 3mg/kg of nivolumab would be used for the dose expansion phase 2 of this study (CA209-039) based on the conclusions derived from CA209-003.
Pre-assignment Details	316 participants treated

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
Arm/Group Description	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W	ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)	ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone	ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)	D regimen: Daratumumab alone
Period Title: Overall Study
Started [1]	105	65	72	6	5	41	22
Completed	1	40	0	1	1	7	6
Not Completed	104	25	72	5	4	34	16
Reason Not Completed
Disease Progression	62	16	52	3	3	31	14
Study Drug Toxicity	14	3	0	0	0	0	1
AE unrelated to study drug	4	3	0	0	0	0	1
Request to discontinue study treatment	5	0	2	0	1	2	0
Withdrew consent	1	2	1	1	0	0	0
Maximum clinical benefit	11	1	7	1	0	0	0
No longer meets study criteria	1	0	0	0	0	0	0
Other Reasons	6	0	10	0	0	1	0
[1] = Number of participants Treated

Baseline Characteristics

Arm/Group Title		Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2	Total
Arm/Group Description		3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W	ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)	ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone	ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)	D regimen: Daratumumab alone	Total of all reporting groups
Overall Number of Baseline Participants		105	65	72	6	5	41	22	316
Baseline Analysis Population Description		[Not Specified]
Age, Categorical [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	105 participants	65 participants	72 participants	6 participants	5 participants	41 participants	22 participants	316 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	66 62.9%	46 70.8%	52 72.2%	3 50.0%	2 40.0%	16 39.0%	11 50.0%	196 62.0%
	>=65 years	39 37.1%	19 29.2%	20 27.8%	3 50.0%	3 60.0%	25 61.0%	11 50.0%	120 38.0%
		[1] Measure Analysis Population Description: All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	105 participants	65 participants	72 participants	6 participants	5 participants	41 participants	22 participants	316 participants
	Female	45 42.9%	28 43.1%	26 36.1%	3 50.0%	1 20.0%	24 58.5%	8 36.4%	135 42.7%
	Male	60 57.1%	37 56.9%	46 63.9%	3 50.0%	4 80.0%	17 41.5%	14 63.6%	181 57.3%
		[1] Measure Analysis Population Description: All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
Ethnicity (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	105 participants	65 participants	72 participants	6 participants	5 participants	41 participants	22 participants	316 participants
	Hispanic or Latino	13 12.4%	3 4.6%	2 2.8%	0 0.0%	0 0.0%	2 4.9%	0 0.0%	20 6.3%
	Not Hispanic or Latino	91 86.7%	62 95.4%	69 95.8%	6 100.0%	5 100.0%	27 65.9%	17 77.3%	277 87.7%
	Unknown or Not Reported	1 1.0%	0 0.0%	1 1.4%	0 0.0%	0 0.0%	12 29.3%	5 22.7%	19 6.0%
		[1] Measure Analysis Population Description: All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
Race (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	105 participants	65 participants	72 participants	6 participants	5 participants	41 participants	22 participants	316 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	2 1.9%	1 1.5%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	3 0.9%
	Native Hawaiian or Other Pacific Islander	1 1.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 0.3%
	Black or African American	11 10.5%	5 7.7%	7 9.7%	0 0.0%	0 0.0%	1 2.4%	2 9.1%	26 8.2%
	White	89 84.8%	58 89.2%	63 87.5%	5 83.3%	5 100.0%	36 87.8%	19 86.4%	275 87.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	2 1.9%	1 1.5%	2 2.8%	1 16.7%	0 0.0%	4 9.8%	1 4.5%	11 3.5%
		[1] Measure Analysis Population Description: All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara

Outcome Measures

1. Primary Outcome

Title	Number of Participants That Experienced Drug Related Grade 3-4 AEs
Description	Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	105	65	72
Measure Type: Count of Participants; Unit of Measure: Participants
	19 18.1%	18 27.7%	0 0.0%

2. Primary Outcome

Title	Number of Participants That Experienced Drug Related Grade 3-4 SAEs
Description	Number and percent of participants that experienced drug related Grade 3-4 SAEs occurring up to 100 days after the last dose of study drug.
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	105	65	72
Measure Type: Count of Participants; Unit of Measure: Participants
	28 26.7%	8 12.3%	3 4.2%

3. Primary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver
Description	Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title		Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:		3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed		105	65	72
Measure Type: Count of Participants; Unit of Measure: Participants
ALT OR AST > 3XULN	Number Analyzed	105 participants	59 participants	72 participants
		3 2.9%	1 1.7%	4 5.6%
ALT OR AST > 5XULN	Number Analyzed	105 participants	59 participants	72 participants
		1 1.0%	0 0.0%	2 2.8%
ALT OR AST > 10XULN	Number Analyzed	105 participants	59 participants	72 participants
		1 1.0%	0 0.0%	1 1.4%
ALT OR AST > 20XULN	Number Analyzed	105 participants	59 participants	72 participants
		1 1.0%	0 0.0%	0 0.0%
TOTAL BILIRUBIN > 2XULN	Number Analyzed	105 participants	59 participants	72 participants
		1 1.0%	1 1.7%	2 2.8%
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY	Number Analyzed	105 participants	59 participants	72 participants
		1 1.0%	0 0.0%	1 1.4%
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS	Number Analyzed	105 participants	59 participants	72 participants
		1 1.0%	0 0.0%	1 1.4%

4. Primary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid
Description	[Not Specified]
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	83	47	72
Measure Type: Count of Participants; Unit of Measure: Participants
TSH > ULN	14 16.9%	19 40.4%	15 20.8%
TSH > ULN WITH TSH <= ULN AT BASELINE	11 13.3%	13 27.7%	9 12.5%
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN	0 0.0%	7 14.9%	1 1.4%
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	1 1.2%	1 2.1%	1 1.4%
TSH > ULN WITH FT3/FT4 TEST MISSING	13 15.7%	11 23.4%	13 18.1%
TSH < LLN	8 9.6%	6 12.8%	6 8.3%
TSH < LLN WITH TSH >= LLN AT BASELINE	5 6.0%	6 12.8%	4 5.6%
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN	0 0.0%	1 2.1%	1 1.4%
TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	0 0.0%	0 0.0%	0 0.0%
TSH < LLN WITH FT3/FT4 TEST MISSING	8 9.6%	5 10.6%	5 6.9%

5. Primary Outcome

Title	Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort

Arm/Group Title	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	6	5	41	22
Measure Type: Count of Participants; Unit of Measure: Participants
Hepatic	0 0.0%	0 0.0%	1 2.4%	0 0.0%
Diarrhea/Colitis	0 0.0%	0 0.0%	1 2.4%	0 0.0%

6. Primary Outcome

Title	Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort

Arm/Group Title	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	6	5	41	22
Measure Type: Count of Participants; Unit of Measure: Participants
	2 33.3%	4 80.0%	10 24.4%	6 27.3%

7. Primary Outcome

Title	Number of Participants That Experience Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort

Arm/Group Title	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	6	5	41	22
Measure Type: Count of Participants; Unit of Measure: Participants
	2 33.3%	4 80.0%	10 24.4%	6 27.3%

8. Primary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort

Arm/Group Title		Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
Arm/Group Description:		ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed		6	5	41	22
Measure Type: Count of Participants; Unit of Measure: Participants
Hemoglobin	Number Analyzed	6 participants	5 participants	41 participants	21 participants
	Grade 0	0 0.0%	0 0.0%	3 7.3%	1 4.8%
	Grade 1	2 33.3%	2 40.0%	13 31.7%	13 61.9%
	Grade 2	2 33.3%	2 40.0%	20 48.8%	5 23.8%
	Grade 3	2 33.3%	1 20.0%	5 12.2%	2 9.5%
	Grade 4	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Platelet count	Number Analyzed	6 participants	5 participants	41 participants	21 participants
	Grade 0	3 50.0%	1 20.0%	19 46.3%	8 38.1%
	Grade 1	2 33.3%	3 60.0%	11 26.8%	9 42.9%
	Grade 2	0 0.0%	1 20.0%	3 7.3%	3 14.3%
	Grade 3	0 0.0%	0 0.0%	3 7.3%	0 0.0%
	Grade 4	1 16.7%	0 0.0%	5 12.2%	1 4.8%
Leukocytes	Number Analyzed	6 participants	5 participants	41 participants	21 participants
	Grade 0	2 33.3%	0 0.0%	10 24.4%	5 23.8%
	Grade 1	1 16.7%	0 0.0%	6 14.6%	9 42.9%
	Grade 2	2 33.3%	2 40.0%	15 36.6%	5 23.8%
	Grade 3	0 0.0%	2 40.0%	9 22.0%	2 9.5%
	Grade 4	1 16.7%	1 20.0%	1 2.4%	0 0.0%
Lymphocytes (Absolute)	Number Analyzed	6 participants	5 participants	41 participants	21 participants
	Grade 0	3 50.0%	0 0.0%	6 14.6%	3 14.3%
	Grade 1	0 0.0%	0 0.0%	9 22.0%	5 23.8%
	Grade 2	0 0.0%	0 0.0%	9 22.0%	7 33.3%
	Grade 3	2 33.3%	3 60.0%	15 36.6%	5 23.8%
	Grade 4	1 16.7%	2 40.0%	2 4.9%	1 4.8%
Absolute Neutrophil Count	Number Analyzed	6 participants	5 participants	41 participants	22 participants
	Grade 0	3 50.0%	0 0.0%	14 34.1%	10 45.5%
	Grade 1	2 33.3%	0 0.0%	8 19.5%	6 27.3%
	Grade 2	0 0.0%	0 0.0%	6 14.6%	6 27.3%
	Grade 3	1 16.7%	3 60.0%	9 22.0%	0 0.0%
	Grade 4	0 0.0%	2 40.0%	4 9.8%	0 0.0%

9. Primary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort

Arm/Group Title	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	6	5	41	22
Measure Type: Count of Participants; Unit of Measure: Participants
ALT or AST >3xULN	0 0.0%	0 0.0%	0 0.0%	0 0.0%
ALT or AST >5xULN	1 16.7%	3 60.0%	9 22.0%	0 0.0%
ALT or AST >10xULN	1 16.7%	3 60.0%	9 22.0%	0 0.0%
ALT or AST >20xULN	1 16.7%	3 60.0%	9 22.0%	0 0.0%
Total Bilirubin > 2xULN	1 16.7%	3 60.0%	9 22.0%	0 0.0%
ALT or AST >3xULN with total Bilirubin > 2xULN within 1 day	1 16.7%	3 60.0%	9 22.0%	0 0.0%
ALT or AST >3xULN with total Bilirubin >2xULN within 30 days	1 16.7%	3 60.0%	9 22.0%	0 0.0%

10. Primary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort with at Least One On-Treatment TSH Measurement

Arm/Group Title	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	6	5	38	19
Measure Type: Count of Participants; Unit of Measure: Participants
TSH>ULN	3 50.0%	1 20.0%	8 21.1%	3 15.8%
TSH > ULN WITH TSH <= ULN AT BASELINE	1 16.7%	1 20.0%	7 18.4%	2 10.5%
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (A)	1 16.7%	0 0.0%	1 2.6%	0 0.0%
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	0 0.0%	0 0.0%	5 13.2%	2 10.5%
WITH FT3/FT4 TEST MISSING	2 33.3%	1 20.0%	2 5.3%	1 5.3%
TSH < LLN	0 0.0%	2 40.0%	2 5.3%	2 10.5%
TSH < LLN WITH TSH >= LLN AT BASELINE	0 0.0%	2 40.0%	2 5.3%	1 5.3%
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN	0 0.0%	0 0.0%	0 0.0%	0 0.0%
TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	0 0.0%	0 0.0%	1 2.6%	2 10.5%
TSH < LLN WITH FT3/FT4 TEST MISSING	0 0.0%	2 40.0%	1 2.6%	0 0.0%

11. Secondary Outcome

Title	Best Overall Response
Description	the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All treated participants with available measurements (excluding Multiple Myeloma (MM) Group)

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	77	58	62
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Complete Response	10.4; (4.6 to 19.4)	13.8; (6.1 to 25.4)	9.7; (3.6 to 19.9)
Partial Response	33.8; (23.4 to 45.4)	34.5; (22.5 to 48.1)	29.0; (18.2 to 41.9)

12. Secondary Outcome

Title	Best Overall Response - Multiple Myeloma Group
Description	the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All Treated participants with available measurements in the Multiple Myeloma (MM) Group

Arm/Group Title		Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:		3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed		27	7	10
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage
Complete Remission	Number Analyzed	27 participants	7 participants	10 participants
		3.7; (0.1 to 19.0)	0; (0.0 to 41.0)	0; (0.0 to 30.8)
Partial Remission	Number Analyzed	27 participants	7 participants	10 participants
		0; (0.0 to 12.8)	0; (0.0 to 41.0)	0; (0.0 to 30.8)
Very Good Partial Response	Number Analyzed	27 participants	7 participants	0 participants
		0; (0.0 to 12.8)	0; (0.0 to 41.0)
Stringent Compete Response	Number Analyzed	27 participants	7 participants	0 participants
		0; (0.0 to 12.8)	0; (0 to 41.0)

13. Secondary Outcome

Title	Duration of Response
Description	the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Remission and Partial Remission
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to approximately 37 months Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All Responding participants (Complete Response and Partial Response) with available measurements (excluding Multiple Myeloma (MM) Group)

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	34	28	24
Median (Full Range); Unit of Measure: Months
	22.83; (0.0 to 48.6)	24.84; (0.0 to 36.5)	19.38; (0.0 to 45.5)

14. Secondary Outcome

Title	Duration of Response - Multiple Myeloma Group
Description	the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All Responding participants (Complete Response and Partial Response) in the Multiple Myeloma (MM) Group

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	1	0	0
Median (Full Range); Unit of Measure: Months
	NA [1]; (NA to NA)

[1]

Median value and Full Range could not be determined because of a single participant analyzed

15. Secondary Outcome

Title	Progression Free Survival
Description	Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment.
Time Frame	From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

All Treated Participants with available measurements

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	104	65	72
Median (95% Confidence Interval); Unit of Measure: Months
	6.24; (3.48 to 9.79)	6.93; (2.79 to 19.15)	3.02; (1.84 to 5.52)

16. Secondary Outcome

Title	Progression Free Survival Rate
Description	The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)
Time Frame	From randomization to the specified timepoints (up to 48 months)

Outcome Measure Data

Analysis Population Description

All Treated Participants with available measurements

Arm/Group Title		Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:		3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed		104	65	72
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
2 Months	Number Analyzed	0 participants	0 participants	72 participants
				58.0; (45.3 to 68.8)
4 Months	Number Analyzed	0 participants	0 participants	72 participants
				42.4; (30.4 to 54.0)
6 Months	Number Analyzed	104 participants	65 participants	72 participants
		50.5; (39.8 to 60.3)	51.5; (38.1 to 63.4)	34.3; (23.0 to 45.8)
9 Months	Number Analyzed	0 participants	0 participants	72 participants
				32.5; (21.4 to 44.0)
12 Months	Number Analyzed	104 participants	65 participants	0 participants
		34.8; (24.2 to 45.5)	45.3; (32.0 to 57.7)
18 Months	Number Analyzed	104 participants	65 participants	0 participants
		31.0; (20.7 to 42.0)	40.1; (26.8 to 53.1)
24 Months	Number Analyzed	104 participants	65 participants	0 participants
		20.3; (11.1 to 31.5)	30.9; (18.0 to 44.9)
36 Months	Number Analyzed	104 participants	0 participants	0 participants
		15.8; (7.6 to 26.8)
48 Months	Number Analyzed	104 participants	0 participants	0 participants
		13.2; (5.6 to 24.1)

17. Secondary Outcome

Title	Overall Survival
Description	The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method
Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to3 years Nivo Liri: approximately up to 4 years 1 month

Outcome Measure Data

Analysis Population Description

All Treated Participants with available measurements

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	104	65	72
Median (95% Confidence Interval); Unit of Measure: Months
	52.57 [1]; (29.0 to NA)	30.39 [1]; (13.24 to NA)	14.95; (9.36 to 34.23)

[1]

Upper limit number not reached

18. Secondary Outcome

Title	Number of Participants With PD-L1 Expression
Description	Number of Participants with PD-L1 expression in the following categories; baseline PD-L1 expression ≥ 1%; baseline PD-L1 expression < 1%; without PD-L1 quantifiable at baseline
Time Frame	At baseline (prior to start of study treatment)

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	105	65	72
Measure Type: Number; Unit of Measure: Number of Participants
Baseline PD-L1 expression ≥ 1%	25	26	16
Baseline PD-L1 expression < 1%	16	14	20
PD-L1 not quantifiable at baseline	64	25	36

19. Secondary Outcome

Title	Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score
Description	mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome).
Time Frame	From baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri)

Outcome Measure Data

Analysis Population Description

All Treated Participants with cutaneous T Cell lymphoma and available measurements

Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab
Arm/Group Description:	3mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Overall Number of Participants Analyzed	1	1	1
Mean (Standard Deviation); Unit of Measure: Percent of change from baseline
	8.70 [1] (NA)	63.03 [2] (NA)	-39.49 [3] (NA)

[1]

Only 1 participant with available measurements at baseline and 88 weeks

[2]

Only 1 participant with available measurements at baseline and 93 weeks

[3]

Only 1 participant with available measurements at baseline and 25 weeks

20. Secondary Outcome

Title	Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort
Description	Time to MRD Negativity status in specific NGS and NGF sensitivity levels
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All Randomized MRD Evaluable Subjects Achieving MRD Negativity

Arm/Group Title		Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:		ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed		1	0	6	4
Mean (Standard Deviation); Unit of Measure: Months
NGS sensitivity level=10e-4	Number Analyzed	1 participants	0 participants	6 participants	1 participants
		3.02 [1] (NA)		3.60 (2.409)	2.83 [1] (NA)
NGS sensitivity level=10e-5	Number Analyzed	1 participants	0 participants	6 participants	0 participants
		3.02 [1] (NA)		5.45 (4.788)
NGS sensitivity level=10e-6	Number Analyzed	1 participants	0 participants	0 participants	0 participants
		30.85 [1] (NA)
NGF sensitivity level=10e-4	Number Analyzed	0 participants	0 participants	4 participants	4 participants
				2.94 (0.230)	4.20 (2.766)
NGF sensitivity level=10e-5	Number Analyzed	0 participants	0 participants	3 participants	0 participants
				6.97 (6.776)
NGF sensitivity level=10e-6	Number Analyzed	0 participants	0 participants	2 participants	0 participants
				12.30 (3.508)

[1]

SD not calculable with 1 participant

21. Secondary Outcome

Title	Objective Response Rate in the Nivolumab + Daratumumab Cohort
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort

Arm/Group Title	Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	6	5	41	22
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage
	66.7; (22.3 to 95.7)	100; (47.8 to 100)	53.7; (37.4 to 69.3)	40.9; (20.7 to 63.6)

22. Secondary Outcome

Title	Duration of Response in the Nivolumab + Daratumumab Cohort
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort

Arm/Group Title	Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	6	5	41	22
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (6.47 to NA)	NA [1]; (9.30 to NA)	7.20; (3.98 to 16.59)	NA [1]; (2.20 to NA)

[1]

Median number not reached. Upper limit number not reached

23. Secondary Outcome

Title	Progression Free Survival in the Nivolumab + Daratumumab Cohort
Description	[Not Specified]
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort

Arm/Group Title	Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	6	5	41	22
Median (95% Confidence Interval); Unit of Measure: Months
	7.56 [1]; (3.19 to NA)	16.95 [2]; (NA to NA)	6.57; (4.67 to 10.25)	6.64; (2.96 to 12.81)

[1]

Upper limit number not reached

[2]

upper and lower limit number not reached

24. Secondary Outcome

Title	Cmax in the Nivolumab + Daratumumab Cohort
Description	Maximum observed serum concentration
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0

Arm/Group Title	Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

25. Secondary Outcome

Title	Tmax in the Nivolumab + Daratumumab Cohort
Description	Time of maximum observed serum concentration
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0

Arm/Group Title	Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

26. Secondary Outcome

Title	Cmin in the Nivolumab + Daratumumab Cohort
Description	Serum concentration achieved at the end of dosing interval (trough concentration)
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0

Arm/Group Title	Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

27. Secondary Outcome

Title	AUC (0-T) in the Nivolumab + Daratumumab Cohort
Description	Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0

Arm/Group Title	Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

28. Secondary Outcome

Title	AUC (TAU) in the Nivolumab + Daratumumab Cohort
Description	Area under the concentration-time curve in one dosing interval
Time Frame	approximately up to 4 years

Outcome Measure Data

Analysis Population Description

All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0

Arm/Group Title	Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

29. Secondary Outcome

Title	End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort
Description	Serum concentration achieved at the end of study drug infusion
Time Frame	Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days

Outcome Measure Data

Analysis Population Description

All treated participants in the nivo dara cohort - pharmacokinetic subset

Arm/Group Title		Cohort A-1	Cohort A-2	Cohort B-1	Cohort B-2
Arm/Group Description:		ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Overall Number of Participants Analyzed		6	5	41	0
Mean (Standard Deviation); Unit of Measure: ug/mL
Cycle 1	Number Analyzed	5 participants	0 participants	32 participants	0 participants
		57.28 (6.78)		69.59 (18.79)
Cycle 2	Number Analyzed	0 participants	0 participants	21 participants	0 participants
				175.73 (88.94)
Cycle 3	Number Analyzed	5 participants	0 participants	6 participants	0 participants
		105.14 (31.41)		193.38 (69.74)
Cycle 5	Number Analyzed	0 participants	0 participants	21 participants	0 participants
				208.14 (58.38)
Cycle 7	Number Analyzed	4 participants	1 participants	3 participants	0 participants
		227.75 (26.79)	206.00 [1] (NA)	193.00 (70.06)
Cycle 11	Number Analyzed	0 participants	1 participants	3 participants	0 participants
			206.00 [1] (NA)	212.00 (38.20)

[1]

Not calculable with only 1 participant

Adverse Events

Time Frame	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month Nivo Dara: approximately 4 years
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
Arm/Group Description	3 mg/kg of nivolumab	3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W	3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W	ND regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old	ND-PD regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	ND regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1 Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1	D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
All-Cause Mortality
	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	53/105 (50.48%)	32/65 (49.23%)	42/72 (58.33%)	1/6 (16.67%)	0/5 (0.00%)	8/41 (19.51%)	6/22 (27.27%)
Serious Adverse Events
	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	50/105 (47.62%)	39/65 (60.00%)	34/72 (47.22%)	3/6 (50.00%)	5/5 (100.00%)	14/41 (34.15%)	9/22 (40.91%)
Blood and lymphatic system disorders
Anaemia † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Eosinophilia † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Febrile neutropenia † 1	3/105 (2.86%)	3/65 (4.62%)	4/72 (5.56%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hyperviscosity syndrome † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Lymph node pain † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Neutropenia † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Pancytopenia † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Thrombocytopenia † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Thrombotic microangiopathy † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Cardiac disorders
Atrial fibrillation † 1	0/105 (0.00%)	2/65 (3.08%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Cardiac failure congestive † 1	1/105 (0.95%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Cardiomyopathy † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Myocardial infarction † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Sinus tachycardia † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Tachycardia † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Ventricular extrasystoles † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Ear and labyrinth disorders
Vertigo † 1	1/105 (0.95%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Eye disorders
Diplopia † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Vision blurred † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Gastrointestinal disorders
Abdominal distension † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Abdominal mass † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Abdominal pain † 1	0/105 (0.00%)	2/65 (3.08%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Autoimmune pancreatitis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Colitis † 1	0/105 (0.00%)	2/65 (3.08%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Constipation † 1	1/105 (0.95%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Diarrhoea † 1	0/105 (0.00%)	3/65 (4.62%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Diverticular perforation † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Enteritis † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Enterocolitis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Fistula of small intestine † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Gastric perforation † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Gastrointestinal haemorrhage † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Immune-mediated enterocolitis † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Nausea † 1	0/105 (0.00%)	1/65 (1.54%)	3/72 (4.17%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pancreatitis † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Small intestinal obstruction † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Vomiting † 1	1/105 (0.95%)	2/65 (3.08%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
General disorders
Asthenia † 1	3/105 (2.86%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Chills † 1	1/105 (0.95%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Fatigue † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Gait disturbance † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Influenza like illness † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Malaise † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Mucosal inflammation † 1	1/105 (0.95%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Multiple organ dysfunction syndrome † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Oedema peripheral † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Pyrexia † 1	6/105 (5.71%)	7/65 (10.77%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	2/41 (4.88%)	0/22 (0.00%)
Sudden cardiac death † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Hepatobiliary disorders
Autoimmune hepatitis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hepatic failure † 1	0/105 (0.00%)	2/65 (3.08%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hepatobiliary disease † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hyperbilirubinaemia † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Immune system disorders
Drug hypersensitivity † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Graft versus host disease † 1	2/105 (1.90%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Infections and infestations
Bacteraemia † 1	1/105 (0.95%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Bronchitis † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	3/41 (7.32%)	0/22 (0.00%)
Clostridium difficile infection † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Cytomegalovirus infection † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Device related infection † 1	0/105 (0.00%)	4/65 (6.15%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Device related sepsis † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Diverticulitis † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Encephalitis † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Endocarditis † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Herpes simplex pharyngitis † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Herpes zoster † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Influenza † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	1/22 (4.55%)
Mucosal infection † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Neutropenic sepsis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Oesophageal candidiasis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Oral candidiasis † 1	0/105 (0.00%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pleural infection † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumocystis jirovecii pneumonia † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonia † 1	3/105 (2.86%)	5/65 (7.69%)	2/72 (2.78%)	2/6 (33.33%)	2/5 (40.00%)	1/41 (2.44%)	3/22 (13.64%)
Pneumonia haemophilus † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonia legionella † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonia mycoplasmal † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonia respiratory syncytial viral † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Rhinovirus infection † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Sepsis † 1	4/105 (3.81%)	2/65 (3.08%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Sepsis syndrome † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Septic shock † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Skin infection † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Staphylococcal bacteraemia † 1	0/105 (0.00%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Staphylococcal sepsis † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Streptococcal bacteraemia † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Streptococcal infection † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Upper respiratory tract infection † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Urinary tract infection † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Wound infection † 1	2/105 (1.90%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Injury, poisoning and procedural complications
Accidental overdose † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Fall † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Hip fracture † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Humerus fracture † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Infusion related reaction † 1	0/105 (0.00%)	2/65 (3.08%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Post procedural fever † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Procedural pneumothorax † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Spinal fracture † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Transfusion reaction † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Investigations
Alanine aminotransferase increased † 1	0/105 (0.00%)	2/65 (3.08%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Aspartate aminotransferase increased † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Blood bilirubin increased † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Blood creatine phosphokinase increased † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Blood creatinine increased † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Liver function test increased † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Platelet count decreased † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Metabolism and nutrition disorders
Decreased appetite † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Dehydration † 1	1/105 (0.95%)	1/65 (1.54%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Diabetic ketoacidosis † 1	0/105 (0.00%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Fluid overload † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypercalcaemia † 1	3/105 (2.86%)	3/65 (4.62%)	3/72 (4.17%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hyperglycaemia † 1	2/105 (1.90%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypoglycaemia † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypokalaemia † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hyponatraemia † 1	1/105 (0.95%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Tumour lysis syndrome † 1	0/105 (0.00%)	0/65 (0.00%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Bone pain † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Groin pain † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Muscular weakness † 1	0/105 (0.00%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Musculoskeletal chest pain † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Myalgia † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Myositis † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Osteonecrosis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Malignant neoplasm progression † 1	13/105 (12.38%)	13/65 (20.00%)	14/72 (19.44%)	1/6 (16.67%)	0/5 (0.00%)	3/41 (7.32%)	2/22 (9.09%)
Metastatic squamous cell carcinoma † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Myelodysplastic syndrome † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Neoplasm malignant † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Plasma cell myeloma † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	2/41 (4.88%)	0/22 (0.00%)
Second primary malignancy † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Tumour flare † 1	0/105 (0.00%)	0/65 (0.00%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Tumour invasion † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Nervous system disorders
Ataxia † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Cerebrovascular accident † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	1/22 (4.55%)
Cognitive disorder † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Dizziness † 1	0/105 (0.00%)	0/65 (0.00%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Headache † 1	1/105 (0.95%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Ischaemic stroke † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Myasthenic syndrome † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Paraesthesia † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Seizure † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Somnolence † 1	2/105 (1.90%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Product Issues
Stent malfunction † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Psychiatric disorders
Completed suicide † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Confusional state † 1	2/105 (1.90%)	2/65 (3.08%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Delirium † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	3/105 (2.86%)	3/65 (4.62%)	3/72 (4.17%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Haematuria † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Renal failure † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome † 1	2/105 (1.90%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Atelectasis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Cough † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Dyspnoea † 1	3/105 (2.86%)	5/65 (7.69%)	2/72 (2.78%)	1/6 (16.67%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Dyspnoea exertional † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Haemoptysis † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypoxia † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pleural effusion † 1	1/105 (0.95%)	0/65 (0.00%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonia aspiration † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonitis † 1	5/105 (4.76%)	4/65 (6.15%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Pulmonary embolism † 1	1/105 (0.95%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Respiratory distress † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Respiratory failure † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Dermatitis bullous † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Dermatitis psoriasiform † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pruritus † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Rash † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Rash maculo-papular † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Rash morbilliform † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Vascular disorders
Deep vein thrombosis † 1	2/105 (1.90%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Embolism † 1	1/105 (0.95%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypertension † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypotension † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
1 Term from vocabulary, 23.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Nivolumab Monotherapy (Expansion)	Nivolumab + Ipilimumab	Nivolumab + Lirilumab	Nivolumab + Daratumumab_Cohort A1	Nivolumab + Daratumumab_Cohort A2	Nivolumab + Daratumumab_Cohort B1	Nivolumab + Daratumumab_Cohort B2
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	102/105 (97.14%)	62/65 (95.38%)	69/72 (95.83%)	6/6 (100.00%)	5/5 (100.00%)	35/41 (85.37%)	16/22 (72.73%)
Blood and lymphatic system disorders
Anaemia † 1	23/105 (21.90%)	12/65 (18.46%)	18/72 (25.00%)	3/6 (50.00%)	4/5 (80.00%)	10/41 (24.39%)	4/22 (18.18%)
Leukopenia † 1	13/105 (12.38%)	1/65 (1.54%)	4/72 (5.56%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Lymphopenia † 1	9/105 (8.57%)	2/65 (3.08%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Neutropenia † 1	12/105 (11.43%)	6/65 (9.23%)	7/72 (9.72%)	1/6 (16.67%)	4/5 (80.00%)	9/41 (21.95%)	2/22 (9.09%)
Thrombocytopenia † 1	21/105 (20.00%)	7/65 (10.77%)	5/72 (6.94%)	1/6 (16.67%)	1/5 (20.00%)	5/41 (12.20%)	2/22 (9.09%)
Pancytopenia † 1	1/105 (0.95%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Cardiac disorders
Tachycardia † 1	0/105 (0.00%)	7/65 (10.77%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Angina pectoris † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	1/41 (2.44%)	0/22 (0.00%)
Sinus tachycardia † 1	2/105 (1.90%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	1/5 (20.00%)	1/41 (2.44%)	0/22 (0.00%)
Ear and labyrinth disorders
Hypoacusis † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Endocrine disorders
Hypothyroidism † 1	6/105 (5.71%)	10/65 (15.38%)	1/72 (1.39%)	1/6 (16.67%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Eye disorders
Vision blurred † 1	1/105 (0.95%)	4/65 (6.15%)	4/72 (5.56%)	0/6 (0.00%)	2/5 (40.00%)	0/41 (0.00%)	0/22 (0.00%)
Dry eye † 1	1/105 (0.95%)	2/65 (3.08%)	2/72 (2.78%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Uveitis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Gastrointestinal disorders
Abdominal distension † 1	2/105 (1.90%)	4/65 (6.15%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Abdominal pain † 1	9/105 (8.57%)	10/65 (15.38%)	5/72 (6.94%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Constipation † 1	12/105 (11.43%)	10/65 (15.38%)	15/72 (20.83%)	0/6 (0.00%)	3/5 (60.00%)	1/41 (2.44%)	0/22 (0.00%)
Diarrhoea † 1	28/105 (26.67%)	20/65 (30.77%)	21/72 (29.17%)	1/6 (16.67%)	4/5 (80.00%)	6/41 (14.63%)	4/22 (18.18%)
Dry mouth † 1	3/105 (2.86%)	4/65 (6.15%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Dyspepsia † 1	1/105 (0.95%)	4/65 (6.15%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Nausea † 1	24/105 (22.86%)	17/65 (26.15%)	15/72 (20.83%)	1/6 (16.67%)	2/5 (40.00%)	3/41 (7.32%)	2/22 (9.09%)
Vomiting † 1	13/105 (12.38%)	9/65 (13.85%)	8/72 (11.11%)	1/6 (16.67%)	2/5 (40.00%)	1/41 (2.44%)	0/22 (0.00%)
Gastritis † 1	0/105 (0.00%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Gastrooesophageal reflux disease † 1	3/105 (2.86%)	3/65 (4.62%)	0/72 (0.00%)	0/6 (0.00%)	2/5 (40.00%)	1/41 (2.44%)	0/22 (0.00%)
Large intestine polyp † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
General disorders
Asthenia † 1	3/105 (2.86%)	3/65 (4.62%)	3/72 (4.17%)	0/6 (0.00%)	1/5 (20.00%)	3/41 (7.32%)	1/22 (4.55%)
Chills † 1	10/105 (9.52%)	10/65 (15.38%)	6/72 (8.33%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	2/22 (9.09%)
Fatigue † 1	46/105 (43.81%)	30/65 (46.15%)	30/72 (41.67%)	2/6 (33.33%)	2/5 (40.00%)	7/41 (17.07%)	3/22 (13.64%)
Influenza like illness † 1	0/105 (0.00%)	1/65 (1.54%)	4/72 (5.56%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	2/22 (9.09%)
Non-cardiac chest pain † 1	3/105 (2.86%)	4/65 (6.15%)	4/72 (5.56%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	2/22 (9.09%)
Oedema peripheral † 1	11/105 (10.48%)	8/65 (12.31%)	7/72 (9.72%)	1/6 (16.67%)	2/5 (40.00%)	1/41 (2.44%)	1/22 (4.55%)
Pain † 1	5/105 (4.76%)	4/65 (6.15%)	3/72 (4.17%)	0/6 (0.00%)	0/5 (0.00%)	3/41 (7.32%)	0/22 (0.00%)
Pyrexia † 1	27/105 (25.71%)	25/65 (38.46%)	8/72 (11.11%)	1/6 (16.67%)	1/5 (20.00%)	4/41 (9.76%)	3/22 (13.64%)
Chest discomfort † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Feeling hot † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Peripheral swelling † 1	3/105 (2.86%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Infections and infestations
Bronchitis † 1	0/105 (0.00%)	1/65 (1.54%)	1/72 (1.39%)	1/6 (16.67%)	0/5 (0.00%)	5/41 (12.20%)	1/22 (4.55%)
Pneumonia † 1	6/105 (5.71%)	4/65 (6.15%)	1/72 (1.39%)	0/6 (0.00%)	3/5 (60.00%)	2/41 (4.88%)	0/22 (0.00%)
Sinusitis † 1	6/105 (5.71%)	4/65 (6.15%)	1/72 (1.39%)	1/6 (16.67%)	1/5 (20.00%)	1/41 (2.44%)	1/22 (4.55%)
Upper respiratory tract infection † 1	17/105 (16.19%)	10/65 (15.38%)	13/72 (18.06%)	2/6 (33.33%)	4/5 (80.00%)	8/41 (19.51%)	3/22 (13.64%)
Urinary tract infection † 1	7/105 (6.67%)	4/65 (6.15%)	3/72 (4.17%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	2/22 (9.09%)
Bronchitis haemophilus † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Cellulitis † 1	0/105 (0.00%)	2/65 (3.08%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Oral candidiasis † 1	1/105 (0.95%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Paronychia † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonia haemophilus † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonia respiratory syncytial viral † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Respiratory tract infection † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	2/22 (9.09%)
Injury, poisoning and procedural complications
Infusion related reaction † 1	4/105 (3.81%)	10/65 (15.38%)	13/72 (18.06%)	2/6 (33.33%)	2/5 (40.00%)	10/41 (24.39%)	4/22 (18.18%)
Contusion † 1	2/105 (1.90%)	3/65 (4.62%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Fall † 1	2/105 (1.90%)	2/65 (3.08%)	1/72 (1.39%)	0/6 (0.00%)	1/5 (20.00%)	2/41 (4.88%)	0/22 (0.00%)
Foot fracture † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Fracture † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Hip fracture † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Investigations
Alanine aminotransferase increased † 1	11/105 (10.48%)	9/65 (13.85%)	8/72 (11.11%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Amylase increased † 1	1/105 (0.95%)	5/65 (7.69%)	4/72 (5.56%)	0/6 (0.00%)	2/5 (40.00%)	0/41 (0.00%)	0/22 (0.00%)
Aspartate aminotransferase increased † 1	13/105 (12.38%)	8/65 (12.31%)	5/72 (6.94%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Blood alkaline phosphatase increased † 1	4/105 (3.81%)	7/65 (10.77%)	6/72 (8.33%)	1/6 (16.67%)	0/5 (0.00%)	3/41 (7.32%)	0/22 (0.00%)
Blood bilirubin increased † 1	2/105 (1.90%)	4/65 (6.15%)	3/72 (4.17%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Blood creatine phosphokinase increased † 1	2/105 (1.90%)	6/65 (9.23%)	9/72 (12.50%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Blood creatinine increased † 1	10/105 (9.52%)	3/65 (4.62%)	4/72 (5.56%)	1/6 (16.67%)	0/5 (0.00%)	2/41 (4.88%)	3/22 (13.64%)
Lipase increased † 1	9/105 (8.57%)	8/65 (12.31%)	3/72 (4.17%)	1/6 (16.67%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Lymphocyte count decreased † 1	2/105 (1.90%)	6/65 (9.23%)	9/72 (12.50%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	1/22 (4.55%)
Neutrophil count decreased † 1	1/105 (0.95%)	2/65 (3.08%)	6/72 (8.33%)	0/6 (0.00%)	2/5 (40.00%)	2/41 (4.88%)	0/22 (0.00%)
Platelet count decreased † 1	0/105 (0.00%)	2/65 (3.08%)	7/72 (9.72%)	0/6 (0.00%)	2/5 (40.00%)	0/41 (0.00%)	1/22 (4.55%)
Weight decreased † 1	6/105 (5.71%)	4/65 (6.15%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Weight increased † 1	4/105 (3.81%)	7/65 (10.77%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
White blood cell count decreased † 1	4/105 (3.81%)	4/65 (6.15%)	8/72 (11.11%)	0/6 (0.00%)	2/5 (40.00%)	0/41 (0.00%)	1/22 (4.55%)
Bilirubin conjugated increased † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Blood thyroid stimulating hormone increased † 1	0/105 (0.00%)	1/65 (1.54%)	2/72 (2.78%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Influenza A virus test positive † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	1/6 (16.67%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Metabolism and nutrition disorders
Decreased appetite † 1	17/105 (16.19%)	12/65 (18.46%)	14/72 (19.44%)	0/6 (0.00%)	1/5 (20.00%)	2/41 (4.88%)	3/22 (13.64%)
Dehydration † 1	3/105 (2.86%)	6/65 (9.23%)	2/72 (2.78%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypercalcaemia † 1	9/105 (8.57%)	4/65 (6.15%)	4/72 (5.56%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hyperglycaemia † 1	16/105 (15.24%)	11/65 (16.92%)	8/72 (11.11%)	1/6 (16.67%)	2/5 (40.00%)	0/41 (0.00%)	2/22 (9.09%)
Hyperkalaemia † 1	2/105 (1.90%)	4/65 (6.15%)	3/72 (4.17%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Hyperuricaemia † 1	12/105 (11.43%)	3/65 (4.62%)	2/72 (2.78%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypoalbuminaemia † 1	10/105 (9.52%)	6/65 (9.23%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Hypocalcaemia † 1	14/105 (13.33%)	7/65 (10.77%)	5/72 (6.94%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	3/22 (13.64%)
Hypokalaemia † 1	11/105 (10.48%)	3/65 (4.62%)	1/72 (1.39%)	0/6 (0.00%)	1/5 (20.00%)	3/41 (7.32%)	2/22 (9.09%)
Hypomagnesaemia † 1	4/105 (3.81%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	4/5 (80.00%)	3/41 (7.32%)	2/22 (9.09%)
Hyponatraemia † 1	9/105 (8.57%)	5/65 (7.69%)	7/72 (9.72%)	0/6 (0.00%)	1/5 (20.00%)	2/41 (4.88%)	1/22 (4.55%)
Hypophosphataemia † 1	8/105 (7.62%)	5/65 (7.69%)	5/72 (6.94%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	2/22 (9.09%)
Hypermagnesaemia † 1	1/105 (0.95%)	1/65 (1.54%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Hypoglycaemia † 1	3/105 (2.86%)	1/65 (1.54%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Type 2 diabetes mellitus † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	18/105 (17.14%)	10/65 (15.38%)	11/72 (15.28%)	3/6 (50.00%)	3/5 (60.00%)	2/41 (4.88%)	0/22 (0.00%)
Back pain † 1	17/105 (16.19%)	11/65 (16.92%)	14/72 (19.44%)	0/6 (0.00%)	1/5 (20.00%)	2/41 (4.88%)	1/22 (4.55%)
Bone pain † 1	2/105 (1.90%)	2/65 (3.08%)	2/72 (2.78%)	0/6 (0.00%)	1/5 (20.00%)	6/41 (14.63%)	2/22 (9.09%)
Muscle spasms † 1	8/105 (7.62%)	3/65 (4.62%)	0/72 (0.00%)	2/6 (33.33%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Musculoskeletal chest pain † 1	6/105 (5.71%)	4/65 (6.15%)	3/72 (4.17%)	1/6 (16.67%)	2/5 (40.00%)	0/41 (0.00%)	0/22 (0.00%)
Myalgia † 1	6/105 (5.71%)	3/65 (4.62%)	5/72 (6.94%)	1/6 (16.67%)	2/5 (40.00%)	1/41 (2.44%)	2/22 (9.09%)
Pain in extremity † 1	9/105 (8.57%)	5/65 (7.69%)	5/72 (6.94%)	1/6 (16.67%)	1/5 (20.00%)	2/41 (4.88%)	1/22 (4.55%)
Arthritis † 1	1/105 (0.95%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Muscular weakness † 1	1/105 (0.95%)	2/65 (3.08%)	1/72 (1.39%)	1/6 (16.67%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Neck pain † 1	5/105 (4.76%)	3/65 (4.62%)	3/72 (4.17%)	1/6 (16.67%)	1/5 (20.00%)	0/41 (0.00%)	1/22 (4.55%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare † 1	0/105 (0.00%)	1/65 (1.54%)	4/72 (5.56%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Colon adenoma † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Nervous system disorders
Dizziness † 1	9/105 (8.57%)	2/65 (3.08%)	2/72 (2.78%)	0/6 (0.00%)	2/5 (40.00%)	3/41 (7.32%)	0/22 (0.00%)
Headache † 1	16/105 (15.24%)	7/65 (10.77%)	5/72 (6.94%)	0/6 (0.00%)	3/5 (60.00%)	2/41 (4.88%)	1/22 (4.55%)
Neuropathy peripheral † 1	9/105 (8.57%)	2/65 (3.08%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	1/22 (4.55%)
Peripheral sensory neuropathy † 1	3/105 (2.86%)	3/65 (4.62%)	1/72 (1.39%)	1/6 (16.67%)	1/5 (20.00%)	3/41 (7.32%)	0/22 (0.00%)
Akathisia † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Dysgeusia † 1	2/105 (1.90%)	1/65 (1.54%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	1/41 (2.44%)	0/22 (0.00%)
Lethargy † 1	1/105 (0.95%)	0/65 (0.00%)	1/72 (1.39%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Memory impairment † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Paraesthesia † 1	0/105 (0.00%)	1/65 (1.54%)	2/72 (2.78%)	1/6 (16.67%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Syncope † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	1/41 (2.44%)	0/22 (0.00%)
Psychiatric disorders
Anxiety † 1	6/105 (5.71%)	2/65 (3.08%)	5/72 (6.94%)	0/6 (0.00%)	0/5 (0.00%)	2/41 (4.88%)	0/22 (0.00%)
Insomnia † 1	7/105 (6.67%)	10/65 (15.38%)	5/72 (6.94%)	1/6 (16.67%)	0/5 (0.00%)	3/41 (7.32%)	0/22 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	5/105 (4.76%)	3/65 (4.62%)	1/72 (1.39%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Proteinuria † 1	3/105 (2.86%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Reproductive system and breast disorders
Benign prostatic hyperplasia † 1	1/105 (0.95%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	1/22 (4.55%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	29/105 (27.62%)	22/65 (33.85%)	11/72 (15.28%)	3/6 (50.00%)	2/5 (40.00%)	4/41 (9.76%)	0/22 (0.00%)
Dyspnoea † 1	17/105 (16.19%)	11/65 (16.92%)	7/72 (9.72%)	2/6 (33.33%)	3/5 (60.00%)	3/41 (7.32%)	1/22 (4.55%)
Dyspnoea exertional † 1	7/105 (6.67%)	2/65 (3.08%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	1/22 (4.55%)
Nasal congestion † 1	11/105 (10.48%)	14/65 (21.54%)	4/72 (5.56%)	2/6 (33.33%)	2/5 (40.00%)	1/41 (2.44%)	0/22 (0.00%)
Oropharyngeal pain † 1	2/105 (1.90%)	5/65 (7.69%)	3/72 (4.17%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	1/22 (4.55%)
Pleural effusion † 1	5/105 (4.76%)	5/65 (7.69%)	3/72 (4.17%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pneumonitis † 1	9/105 (8.57%)	6/65 (9.23%)	2/72 (2.78%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Rhinitis allergic † 1	2/105 (1.90%)	0/65 (0.00%)	1/72 (1.39%)	0/6 (0.00%)	2/5 (40.00%)	2/41 (4.88%)	0/22 (0.00%)
Bronchospasm † 1	2/105 (1.90%)	0/65 (0.00%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Dysphonia † 1	0/105 (0.00%)	2/65 (3.08%)	1/72 (1.39%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Productive cough † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	2/5 (40.00%)	0/41 (0.00%)	1/22 (4.55%)
Rhinorrhoea † 1	5/105 (4.76%)	2/65 (3.08%)	1/72 (1.39%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Tachypnoea † 1	0/105 (0.00%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Upper-airway cough syndrome † 1	5/105 (4.76%)	1/65 (1.54%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Skin and subcutaneous tissue disorders
Alopecia † 1	6/105 (5.71%)	1/65 (1.54%)	4/72 (5.56%)	0/6 (0.00%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Dry skin † 1	8/105 (7.62%)	3/65 (4.62%)	2/72 (2.78%)	1/6 (16.67%)	0/5 (0.00%)	1/41 (2.44%)	0/22 (0.00%)
Hyperhidrosis † 1	6/105 (5.71%)	2/65 (3.08%)	2/72 (2.78%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	1/22 (4.55%)
Night sweats † 1	4/105 (3.81%)	4/65 (6.15%)	4/72 (5.56%)	0/6 (0.00%)	0/5 (0.00%)	0/41 (0.00%)	0/22 (0.00%)
Pruritus † 1	25/105 (23.81%)	11/65 (16.92%)	9/72 (12.50%)	1/6 (16.67%)	4/5 (80.00%)	3/41 (7.32%)	0/22 (0.00%)
Rash † 1	22/105 (20.95%)	12/65 (18.46%)	8/72 (11.11%)	0/6 (0.00%)	1/5 (20.00%)	1/41 (2.44%)	0/22 (0.00%)
Rash maculo-papular † 1	3/105 (2.86%)	8/65 (12.31%)	5/72 (6.94%)	0/6 (0.00%)	0/5 (0.00%)	2/41 (4.88%)	1/22 (4.55%)
Erythema † 1	0/105 (0.00%)	2/65 (3.08%)	1/72 (1.39%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	1/22 (4.55%)
Vascular disorders
Hot flush † 1	1/105 (0.95%)	5/65 (7.69%)	0/72 (0.00%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
Hypertension † 1	6/105 (5.71%)	1/65 (1.54%)	1/72 (1.39%)	0/6 (0.00%)	0/5 (0.00%)	3/41 (7.32%)	1/22 (4.55%)
Hypotension † 1	8/105 (7.62%)	1/65 (1.54%)	3/72 (4.17%)	0/6 (0.00%)	1/5 (20.00%)	0/41 (0.00%)	0/22 (0.00%)
Flushing † 1	3/105 (2.86%)	0/65 (0.00%)	0/72 (0.00%)	0/6 (0.00%)	1/5 (20.00%)	1/41 (2.44%)	0/22 (0.00%)
Haematoma † 1	0/105 (0.00%)	0/65 (0.00%)	1/72 (1.39%)	1/6 (16.67%)	0/5 (0.00%)	0/41 (0.00%)	1/22 (4.55%)
1 Term from vocabulary, 23.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb
• Phone: Please email
• EMail: Clinical.Trials@bms.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lesokhin AM, Ansell SM, Armand P, Scott EC, Halwani A, Gutierrez M, Millenson MM, Cohen AD, Schuster SJ, Lebovic D, Dhodapkar M, Avigan D, Chapuy B, Ligon AH, Freeman GJ, Rodig SJ, Cattry D, Zhu L, Grosso JF, Bradley Garelik MB, Shipp MA, Borrello I, Timmerman J. Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study. J Clin Oncol. 2016 Aug 10;34(23):2698-704. doi: 10.1200/JCO.2015.65.9789. Epub 2016 Jun 6.

Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med. 2015 Jan 22;372(4):311-9. doi: 10.1056/NEJMoa1411087. Epub 2014 Dec 6.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01592370
• Other Study ID Numbers: CA209-039; 2018-001030-17 ( EudraCT Number )
• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Results First Submitted: September 24, 2021
• Results First Posted: February 17, 2022
• Last Update Posted: September 13, 2023