Nivolumab in Combination With Chemotherapy, or Nivolumab in Combination With Ipilimumab, in Advanced EGFR-Mutant or ALK-Rearranged NSCLC

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ClinicalTrials.gov Identifier: NCT03256136

Recruitment Status : Completed

First Posted : August 21, 2017

Results First Posted : October 19, 2020

Last Update Posted : November 4, 2020

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

Alice Shaw, Massachusetts General Hospital

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Lung Cancer
Interventions	Drug: Carboplatin Drug: Nivolumab Drug: pemetrexed Drug: Ipilimumab
Enrollment	9

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
Arm/Group Description	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...
Arm/Group Description	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy
Period Title: Overall Study
Started	3	1	4	1
Completed	3	1	4	1
Not Completed	0	0	0	0

Baseline Characteristics

Arm/Group Title		Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive	Total
Arm/Group Description		Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Total of all reporting groups
Arm/Group Description		Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Total of all reporting groups
Overall Number of Baseline Participants		3	1	4	1	9
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	1 participants	4 participants	1 participants	9 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	1 33.3%	1 100.0%	2 50.0%	1 100.0%	5 55.6%
	>=65 years	2 66.7%	0 0.0%	2 50.0%	0 0.0%	4 44.4%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	1 participants	4 participants	1 participants	9 participants
	Female	2 66.7%	1 100.0%	1 25.0%	0 0.0%	4 44.4%
	Male	1 33.3%	0 0.0%	3 75.0%	1 100.0%	5 55.6%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	1 participants	4 participants	1 participants	9 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	1 33.3%	0 0.0%	2 50.0%	0 0.0%	3 33.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	2 66.7%	1 100.0%	2 50.0%	1 100.0%	6 66.7%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	3 participants	1 participants	4 participants	1 participants	9 participants
United States		3	1	4	1	9
Treatment Regimen Received Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	1 participants	4 participants	1 participants	9 participants
		3 100.0%	1 100.0%	4 100.0%	1 100.0%	9 100.0%

Outcome Measures

1.Primary Outcome


Title	Objective Response Rate (ORR), Presented in Numbers of Participants
Description	Complete response (CR) or partial response (PR) per Response Evaluatio...
Description	Complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame	Up to approximately 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
Arm/Group Description:	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...
Arm/Group Description:	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy
Overall Number of Participants Analyzed	3	1	4	1
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%	1 25.0%	1 100.0%

2.Secondary Outcome


Title	Disease Control Rate (DCR), Presented in Numbers of Participants
Description	The number of patients that achieved either complete response (CR), pa...
Description	The number of patients that achieved either complete response (CR), partial response (PR), or stable disease (SD) per RECIST version 1.1 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time Frame	Up to approximately 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
Arm/Group Description:	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...
Arm/Group Description:	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy
Overall Number of Participants Analyzed	3	1	4	1
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%	3 75.0%	1 100.0%

3.Secondary Outcome


Title	Progression Free Survival (PFS)
Description	Time from initiation of the study drugs to progression or death, which...
Description	Time from initiation of the study drugs to progression or death, whichever occurs first. Disease progression was assessed via RECIST 1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progression). Confidence Intervals (CIs) were calculated using the Kaplan Meier (KM) method
Time Frame	From the start of treatment until disease progression or death due to any cause, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
Arm/Group Description:	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...
Arm/Group Description:	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy
Overall Number of Participants Analyzed	3	1	4	1
Median (95% Confidence Interval) Unit of Measure: months
	1.3 (0.6 to 1.4)	0.7 ^[1] (NA to NA)	4.65 (1.2 to 8.4)	2.8 ^[1] (NA to NA)

[1]

confidence interval is not defined due to an insufficient number of events

4.Secondary Outcome


Title	Overall Survival (OS)
Description	Time from initiation of the study drugs to date of death due to any ca...
Description	Time from initiation of the study drugs to date of death due to any cause. CIs are the KM estimate CIs.
Time Frame	From the start of treatment until death due to any cause, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
Arm/Group Description:	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...
Arm/Group Description:	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy
Overall Number of Participants Analyzed	3	1	4	1
Median (95% Confidence Interval) Unit of Measure: months
	22.3 (2.6 to 23.7)	7.6 ^[1] (NA to NA)	7.75 (2.1 to 16.2)	15.9 ^[1] (NA to NA)

[1]

confidence interval is not defined due to an insufficient number of events

5.Secondary Outcome


Title	Duration Of Response
Description	Time from the first documentation of objective tumor response (CR or P...
Description	Time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progression).
Time Frame	From the first documented response until disease progression or death, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
Arm/Group Description:	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...
Arm/Group Description:	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy
Overall Number of Participants Analyzed	3	1	4	1
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)	0.9 ^[2] (NA to NA)	1.4 ^[2] (NA to NA)

[1]

no objective responses in this cohort

[2]

confidence interval is not defined due to an insufficient number of events

Adverse Events

Time Frame	From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
Arm/Group Description	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...	Nivolumab administered intravenousl...
Arm/Group Description	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks Nivolumab: will allow the body's immune system to work against tumor cells Ipilimumab: will allow the body's immune system to work against tumor cells	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy	Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks Carboplatin: Chemotherapy Nivolumab: will allow the body's immune system to work against tumor cells pemetrexed: Chemo therapy
All-Cause Mortality
	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/3 (0.00%)	1/1 (100.00%)	2/4 (50.00%)	0/1 (0.00%)
Serious Adverse Events Serious Adverse Events
	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/3 (0.00%)	1/1 (100.00%)	3/4 (75.00%)	0/1 (0.00%)
Blood and lymphatic system disorders
Anemia ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Neutrophil count decrease ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Ear and labyrinth disorders
Vertigo ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Infections and infestations
Skin infection ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Injury, poisoning and procedural complications
Fall ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Investigations
Blood bilirubin increase ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Nervous system disorders
Seizure ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^† 1	0/3 (0.00%)	1/1 (100.00%)	0/4 (0.00%)	0/1 (0.00%)
Aspiration ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Nivolumab Plus Ipilimumab EGFR	Nivolumab Plus Ipilimumab ALK	Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive	Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/3 (100.00%)	0/1 (0.00%)	4/4 (100.00%)	1/1 (100.00%)
Blood and lymphatic system disorders
Anemia ^† 1	0/3 (0.00%)	0/1 (0.00%)	3/4 (75.00%)	0/1 (0.00%)
Cardiac disorders
Sinus bradycardia ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Chest pain - cardiac ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Ear and labyrinth disorders
Vertigo ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Endocrine disorders
Hyperthyroidism ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Eye disorders
Floaters ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Eye disorders - other: red vision ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Gastrointestinal disorders
Constipation ^† 1	1/3 (33.33%)	0/1 (0.00%)	2/4 (50.00%)	1/1 (100.00%)
Diarrhea ^† 1	1/3 (33.33%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Nausea ^† 1	1/3 (33.33%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Vomiting ^† 1	1/3 (33.33%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Dyspepsia ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Anal hemorrhage ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Abdominal pain ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
General disorders
Fatigue ^† 1	2/3 (66.67%)	0/1 (0.00%)	4/4 (100.00%)	0/1 (0.00%)
Pain ^† 1	1/3 (33.33%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
General disorders, other - Tick bite ^† 1	1/3 (33.33%)	0/1 (0.00%)	0/4 (0.00%)	0/1 (0.00%)
Fever ^† 1	1/3 (33.33%)	0/1 (0.00%)	0/4 (0.00%)	0/1 (0.00%)
Gait disturbance ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Edema limbs ^† 1	0/3 (0.00%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Non-cardiac chest pain ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Infections and infestations
Rash pustular ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Gum infection ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Platelet count decreased ^† 1	0/3 (0.00%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Nail infection ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	1/3 (33.33%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Aspartate aminotransferase increased ^† 1	1/3 (33.33%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Lipase increased ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Creatinine increased ^† 1	1/3 (33.33%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Weight loss ^† 1	1/3 (33.33%)	0/1 (0.00%)	0/4 (0.00%)	0/1 (0.00%)
White blood cell decreased ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Neutrophil count decreased ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Alkaline phosphatase increased ^† 1	0/3 (0.00%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Weight gain ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Lymphocyte decreased ^† 1	0/3 (0.00%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Metabolism and nutrition disorders
Anorexia ^† 1	2/3 (66.67%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Dehydration ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/3 (33.33%)	0/1 (0.00%)	0/4 (0.00%)	0/1 (0.00%)
Back pain ^† 1	1/3 (33.33%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Generalized muscle weakness ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Nervous system disorders
Neuropathy ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Headache ^† 1	1/3 (33.33%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Dizziness ^† 1	1/3 (33.33%)	0/1 (0.00%)	2/4 (50.00%)	0/1 (0.00%)
Nervous system disorders, other - numbness to chin and extremities ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Psychiatric disorders
Anxiety ^† 1	0/3 (0.00%)	0/1 (0.00%)	0/4 (0.00%)	1/1 (100.00%)
Insomnia ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Depression ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Renal and urinary disorders
Proteinuria ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Hematuria ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Urine discoloration ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^† 1	2/3 (66.67%)	0/1 (0.00%)	1/4 (25.00%)	1/1 (100.00%)
Cough ^† 1	1/3 (33.33%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Nasal congestion ^† 1	1/3 (33.33%)	0/1 (0.00%)	0/4 (0.00%)	0/1 (0.00%)
Hoarseness ^† 1	1/3 (33.33%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Sneezing ^† 1	1/3 (33.33%)	0/1 (0.00%)	0/4 (0.00%)	0/1 (0.00%)
Wheezing ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Hiccups ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Dry skin ^† 1	1/3 (33.33%)	0/1 (0.00%)	0/4 (0.00%)	0/1 (0.00%)
Rash maculopapular ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
Skin induration ^† 1	0/3 (0.00%)	0/1 (0.00%)	1/4 (25.00%)	0/1 (0.00%)
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

More Information

Certain Agreements

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

There is NOT 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

Layout table for Results Point of Contact information

Name/Title:	Dr. Jessica Lin
Organization:	Massachusetts General Hospital
Phone:	617-724-1134
EMail:	jjlin1@partners.org

Layout table for additonal information

Responsible Party:	Alice Shaw, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT03256136
Other Study ID Numbers:	17-011
First Submitted:	August 17, 2017
First Posted:	August 21, 2017
Results First Submitted:	September 22, 2020
Results First Posted:	October 19, 2020
Last Update Posted:	November 4, 2020

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