Study of Optimized Management of Nivolumab Based on Response in Patients With Advanced RCC (OMNIVORE Study)

• ClinicalTrials.gov Identifier: NCT03203473
• Recruitment Status: Active, not recruiting
• First Posted: June 29, 2017
• Results First Posted: April 25, 2022
• Last Update Posted: May 17, 2023
• Sponsor: Toni Choueiri, MD
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): Toni Choueiri, MD, Dana-Farber Cancer Institute

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Cancer
• Interventions: Drug: Ipilimumab; Drug: Nivolumab
• Enrollment: 85

Participant Flow

Recruitment Details	Eighty-five patients were enrolled between October 2017 and July 2019 at 10 centers in the United States. Two patients never initiated treatment, resulting in 83 patients for analysis.
Pre-assignment Details

Arm/Group Title	Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)	Arm A: Observation Arm (for Patients With Persistent Response to Induction Nivolumab)	Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
Arm/Group Description	Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles; Serial imaging assessments every 8 weeks; After confirmatory scans, patients are assigned to Arm A or Arm B. Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs	Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm); Serial imaging assessments every 8 weeks; If progressive disease develops, salvage therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.; If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.; If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.	Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).; In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.; After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.; Arm B patients underwent imaging at 12 weeks and then every 8 weeks.
Period Title: Induction Phase
Started	85	0	0
Completed	69	0	0
Not Completed	16	0	0
Reason Not Completed
Never started primary treatment	2	0	0
Withdrew from study due to progressive disease	7	0	0
Withdrew from study due to toxicity	7	0	0
Period Title: Arm Allocation Phase
Started [1]	0	12	57
Completed	0	0	0
Not Completed	0	12	57
Reason Not Completed
Still on Arm A-observation	0	7	0
started salvage therapy	0	5	0
Disease progression	0	0	37
Adverse Event	0	0	11
Physician Decision	0	0	3
Death	0	0	1
Developed 2nd cancer	0	0	1
Intercurrent illness	0	0	1
Still on arm-B treatment	0	0	3
[1] All 85 patients were off primary treatment (induction phase), of whom, 69 patients entered the 2nd period (12 were allocated to Arm A and 57 were allocated to Arm B).

Baseline Characteristics

Arm/Group Title		Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)
Arm/Group Description		Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks); Serial imaging assessments every 8 weeks; After confirmatory scans, patients are assigned to Arm A or Arm B. Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
Overall Number of Baseline Participants		83
Baseline Analysis Population Description		Out of 85 patients enrolled, 83 patients received protocol treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	83 participants
		61; (33 to 79)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	83 participants
	Female	15 18.1%
	Male	68 81.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	83 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	3 3.6%
	White	75 90.4%
	More than one race	4 4.8%
	Unknown or Not Reported	1 1.2%
Histology; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	83 participants
	Clear Cell	80 96.4%
	Non-clear Cell	3 3.6%
Previous systemic therapy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	83 participants
	No	42 50.6%
	Yes	41 49.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Persistent Partial Response (PR) or Complete Response (CR) at 1 Year Since Nivolumab Discontinuation (Arm A Only)
Description	Persistent PR or CR is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks after patients discontinued nivolumab induction therapy. At 1 year after nivolumab discontinuation, the percentage of patients with persistent PR and CR were reported (for Arm A only).
Time Frame	From nivolumab discontinuation until 1 year after discontinuation with nivolumab

Outcome Measure Data

Analysis Population Description

12 patients were assigned to arm A after nivolumab induction therapy.

Arm/Group Title	Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
Arm/Group Description:	Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm); Serial imaging assessments every 8 weeks; If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.; If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.; If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
Overall Number of Participants Analyzed	12
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: percentage of participants
	42; (18 to 68)

2. Primary Outcome

Title	Percentage of Subjects With Stable or Progressive Disease (SD/PD) to Nivolumab Induction That Convert to Complete or Partial Response (CR/PR) Upon the Addition of Ipilimumab to Nivolumab (Arm B Only)
Description	Response is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guideline. After initiation of ipilimumab, Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks until disease progression. Best overall response during Arm B treatment were summarized with 90% confidence interval.
Time Frame	For arm B patients, from arm B treatment (nivolumab+ipilimumab) initiation until last imaging assessment during the treatment; assessed up to 22 months.

Outcome Measure Data

Analysis Population Description

57 patients were assigned to Arm B after nivolumab induction therapy

Arm/Group Title	Arm B Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
Arm/Group Description:	Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).; In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.; After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.; Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
Overall Number of Participants Analyzed	57
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: percentage of participants
	4; (1 to 11)

3. Secondary Outcome

Title	Median Progression Free Survival (Arm B)
Description	Progression-free survival (PFS) for Arm B was defined as time from the start of arm B treatment until progression (by RECIST 1.1 or clinical PD) or death from any cause or censored at date of last disease evaluation for those who are alive and have not progressed. PFS distribution was estimated using the product-limit method of Kaplan-Meier, median and 95% confidence interval was reported.
Time Frame	After initiation of Arm B treatment, patients underwent imaging at 12 weeks and then every 8 weeks, up to 22 months.

Outcome Measure Data

Analysis Population Description

57 patients were allocated to Arm B treatment after completing nivolumab induction

Arm/Group Title	Arm B Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
Arm/Group Description:	Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).; In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.; After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.; Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
Overall Number of Participants Analyzed	57
Median (95% Confidence Interval); Unit of Measure: months
	4.7; (2.7 to 8.3)

4. Secondary Outcome

Title	18-month Overall Survival Rate From Initiation of Nivolumab Induction (Overall Cohort)
Description	Overall survival (OS) was defined as the time from initiation of nivolumab induction until death due to any cause or censored at date of last follow-up for surviving patients. OS rate was estimated using the product-limit method of Kaplan-Meier;18-month OS rate and 95% confidence interval were reported.
Time Frame	Patients were followed from initiation of Nivolumab induction until to death or date last known alive. Kaplan-Meier curve for OS assessed up to 28 months; the 18-month time point estimate for OS was reported.

Outcome Measure Data

Analysis Population Description

Out of 85 patients enrolled, 83 patients received nivolumab induction treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.

Arm/Group Title	Initial Primary Treatment With Nivolumab (Induction Phase)
Arm/Group Description:	Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks); Serial imaging assessments every 8 weeks; After confirmatory scans, patients are assigned to Arm A or Arm B. Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
Overall Number of Participants Analyzed	83
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	79; (67 to 87)

5. Secondary Outcome

Title	Percent of Subjects Who Were Free of Nivolumab Salvage Therapy at 1 Year Since Discontinuation of Nivolumab Induction (Arm A)
Description	Number and proportion of arm A patients who remained free of nivolumab treatment at 1 year since discontinuation of nivolumab induction
Time Frame	For arm A, from nivolumab discontinuation until 1 year after discontinuation with nivolumab

Outcome Measure Data

Analysis Population Description

12 patients were allocated to arm A (observation arm) after nivolumab induction therapy.

Arm/Group Title	Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
Arm/Group Description:	Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm); Serial imaging assessments every 8 weeks; If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.; If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.; If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
Overall Number of Participants Analyzed	12
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: percentage of participants
	42; (18 to 68)

6. Secondary Outcome

Title	Immune Related Objective Response Rate (irORR) in Arm A and Arm B
Description	The irORR is assessed according to immune-related Response Criteria (irRC).; Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions (index and non-index together with no new measurable/unmeasurable lesions) for at least 4 weeks from the date of documentation of complete response; Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters (SPD) of all target and all new measurable lesions in two consecutive observations not less than 4 weeks apart.
Time Frame	For arm A, radiology imaging will be done every 8 weeks until disease progression. For arm B, radiology imaging will be done at 12 weeks and then every 8 weeks until disease progression

Outcome Measure Data

Analysis Population Description

Since the trial was designed in 2015, immune-related response has been infrequently used in VEGF/IO trials for kidney cancer. Most RCC trials have mainly focused on the traditional RECIST-based response as the primary endpoint. Therefore, the study team did not pursue immune-related response assessment and that data was not collected.

Arm/Group Title	Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)	Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)
Arm/Group Description:	Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm); Serial imaging assessments every 8 weeks; If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.; If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.; If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.	Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).; In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.; After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.; Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Percentage of Subjects Who Experience Grade 3-4 Treatment-related Adverse Event (TRAE) During the Nivolumab Induction Therapy (Overall Cohort)
Description	Adverse event was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4. The following AE attribution was considered as treatment-related: Definite - The AE is clearly related to the study treatment.; Probable - The AE is likely related to the study treatment.; Possible - The AE may be related to the study treatment.
Time Frame	Adverse events during the nivolumab induction were measured from nivolumab initiation until 3 months following the last dose of nivolumab induction or until start of arm B treatment, assessed up to 9 months from nivolumab start

Outcome Measure Data

Analysis Population Description

Out of 85 patients enrolled, 83 patients received nivolumab induction treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.

Arm/Group Title	Initial Primary Treatment With Nivolumab (Induction Phase)
Arm/Group Description:	Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.; Serial imaging assessments every 8 weeks; After confirmatory scans, patients are assigned to Arm A or Arm B. Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
Overall Number of Participants Analyzed	83
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	7; (3 to 15)

8. Secondary Outcome

Title	Percentage of Subjects Who Experienced Grade 3-4 Treatment Related Adverse Events (TRAE) During the Arm B Treatment (Arm B Only)
Description	Adverse event was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4. The following AE attribution was considered as treatment-related: Definite - The AE is clearly related to the study treatment.; Probable - The AE is likely related to the study treatment.; Possible - The AE may be related to the study treatment.
Time Frame	For arm B, adverse events were measured from arm B treatment initiation until 3 months following the last dose of arm B treatment, assessed up to 26 months from arm B start

Outcome Measure Data

Analysis Population Description

57 patients had been allocated to arm B after nivolumab induction therapy

Arm/Group Title	Arm B Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)
Arm/Group Description:	Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).; In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.; After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.; Arm B patients underwent imaging at 12 weeks and then every 8 weeks until disease progression.
Overall Number of Participants Analyzed	57
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	25; (14 to 38)

9. Secondary Outcome

Title	Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to International mRCC Database Consortium (IMDC) Risk Groups.
Description	Response (PR or CR) is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks during the induction therapy with nivolumab.
Time Frame	From start of nivolumab induction until the discontinuation of nivolumab induction, assessed up to 7 months

Outcome Measure Data

Analysis Population Description

Out of 85 patients enrolled, 83 patients received nivolumab induction treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.

Arm/Group Title		Initial Primary Treatment With Nivolumab (Induction Phase)
Arm/Group Description:		Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.; Serial imaging assessments every 8 weeks; After confirmatory scans, patients are assigned to Arm A or Arm B. Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
Overall Number of Participants Analyzed		83
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: percentage of participants
IMDC favorable risk	Number Analyzed	27 participants
		11; (3 to 26)
IMDC intermediate risk	Number Analyzed	45 participants
		13; (6 to 25)
IMDC poor risk	Number Analyzed	11 participants
		9; (1 to 36)

10. Secondary Outcome

Title	Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to Prior Treatment
Description	Response (PR or CR) is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks during the induction therapy with nivolumab.
Time Frame	From start of nivolumab induction until the discontinuation of nivolumab induction, assessed up to 7 months

Outcome Measure Data

Analysis Population Description

Out of 85 patients enrolled, 83 patients received nivolumab induction treatment and were included for analysis; 2 patients who did not proceed with treatment were excluded from all analysis.

Arm/Group Title		Initial Primary Treatment With Nivolumab (Induction Phase)
Arm/Group Description:		Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.; Serial imaging assessments every 8 weeks; After confirmatory scans, patients are assigned to Arm A or Arm B. Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
Overall Number of Participants Analyzed		83
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: percentage of participants
Treatment Naive	Number Analyzed	42 participants
		12; (5 to 23)
Previously treated	Number Analyzed	41 participants
		12; (5 to 24)

11. Secondary Outcome

Title	Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivolumab Induction Therapy According to Histology Type
Description	Response (PR or CR) is defined per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Radiologic disease assessment was performed every 8 weeks during the induction therapy with nivolumab.
Time Frame	From start of nivolumab induction until the discontinuation of nivolumab induction, assessed up to 7 months

Outcome Measure Data

Analysis Population Description

Given the majority (96%) of patients had clear cell histology, subgroup analysis of response by histology type was not performed.

Arm/Group Title	Initial Primary Treatment With Nivolumab (Induction Phase)
Arm/Group Description:	Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.; Serial imaging assessments every 8 weeks; After confirmatory scans, patients are assigned to Arm A or Arm B. Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	Overall cohort (nivolumab induction): adverse event (AE) was measured from nivolumab start until 3 months following the last dose of nivolumab or until start of arm B treatment, up to 9 months from nivolumab start. Arm B (nivolumab+ipilimamab then nivolumab alone): AE was measured from arm B treatment start until 3 months following the last dose of arm B treatment, up to 26 months from arm B start. Arm A (observation arm): AE was not reported as patents were in observation arm.
Adverse Event Reporting Description	Overall cohort included 83 patients who received nivolumab, excluding 2 patients who did not receive treatment. Arm B: 57 patients on arm B were assessed for AE. Serious AEs included those with a severity grade of 3 or higher and a treatment attribution of possible, probable, or definite. Arm A:12 patients on arm A. AE was not reported since this was an observation arm. If a patient resumes therapy after progression to arm A, AE from subsequent therapy was not counted as arm A toxicities.
Arm/Group Title	Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)	Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)	Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
Arm/Group Description	Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.; Serial imaging assessments every 8 weeks; After confirmatory scans, patients are assigned to Arm A or Arm B. Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs	Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).; In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.; After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.; Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks.. Ipilimumab: YERVOY is thought to work with the body's immune system to increase the activity of T cells and cause the body to attack cancer cells Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs	Patients with persistent response (complete or partial response) to induction nivolumab are assigned to Arm A (Observation Arm). - AE was not reported since this was an observation arm. If a patient resumes nivolumab therapy after progression to arm A, AE from the subsequent therapy was not counted as arm A toxicities.
All-Cause Mortality
	Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)	Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)	Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	19/83 (22.89%)	12/57 (21.05%)	1/12 (8.33%)
Serious Adverse Events
	Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)	Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)	Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/83 (7.23%)	14/57 (24.56%)	0/12 (0.00%)
Endocrine disorders
Adrenal insufficiency † 1	0/83 (0.00%)	2/57 (3.51%)	0/12 (0.00%)
Eye disorders
Eye disorders - Other, specify † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Gastrointestinal disorders
Colitis † 1	0/83 (0.00%)	2/57 (3.51%)	0/12 (0.00%)
Diarrhea † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
General disorders
General disorders and administration site conditions - Other, specify † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Infusion related reaction † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Hepatobiliary disorders
Portal hypertension † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Portal vein thrombosis † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Investigations
Alanine aminotransferase increased † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Alkaline phosphatase increased † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Aspartate aminotransferase increased † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Blood bilirubin increased † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
CPK increased † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Creatinine increased † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Metabolism and nutrition disorders
Acidosis † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Hyperglycemia † 1	2/83 (2.41%)	4/57 (7.02%)	0/12 (0.00%)
Hyperkalemia † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Hyponatremia † 1	1/83 (1.20%)	2/57 (3.51%)	0/12 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Generalized muscle weakness † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Myositis † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Renal and urinary disorders
Renal and urinary disorders - Other, specify † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Hypoxia † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Pneumonitis † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (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	0%
	Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)	Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)	Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	80/83 (96.39%)	55/57 (96.49%)	0/12 (0.00%)
Blood and lymphatic system disorders
Anemia † 1	11/83 (13.25%)	2/57 (3.51%)	0/12 (0.00%)
Blood and lymphatic system disorders - Other, specify † 1	0/83 (0.00%)	2/57 (3.51%)	0/12 (0.00%)
Leukocytosis † 1	1/83 (1.20%)	2/57 (3.51%)	0/12 (0.00%)
Cardiac disorders
Atrial fibrillation † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Chest pain - cardiac † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Heart failure † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Mitral valve disease † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Sinus tachycardia † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Endocrine disorders
Adrenal insufficiency † 1	0/83 (0.00%)	3/57 (5.26%)	0/12 (0.00%)
Endocrine disorders - Other, specify † 1	2/83 (2.41%)	2/57 (3.51%)	0/12 (0.00%)
Hyperthyroidism † 1	2/83 (2.41%)	3/57 (5.26%)	0/12 (0.00%)
Hypothyroidism † 1	3/83 (3.61%)	5/57 (8.77%)	0/12 (0.00%)
Eye disorders
Blurred vision † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Dry eye † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Eye disorders - Other, specify † 1	3/83 (3.61%)	1/57 (1.75%)	0/12 (0.00%)
Flashing lights † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Gastrointestinal disorders
Abdominal pain † 1	4/83 (4.82%)	3/57 (5.26%)	0/12 (0.00%)
Bloating † 1	3/83 (3.61%)	1/57 (1.75%)	0/12 (0.00%)
Colitis † 1	0/83 (0.00%)	3/57 (5.26%)	0/12 (0.00%)
Constipation † 1	7/83 (8.43%)	4/57 (7.02%)	0/12 (0.00%)
Diarrhea † 1	16/83 (19.28%)	10/57 (17.54%)	0/12 (0.00%)
Dry mouth † 1	5/83 (6.02%)	2/57 (3.51%)	0/12 (0.00%)
Dyspepsia † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Dysphagia † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Flatulence † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Gastroesophageal reflux disease † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Gastrointestinal disorders - Other, specify † 1	4/83 (4.82%)	3/57 (5.26%)	0/12 (0.00%)
Gastrointestinal pain † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Hemorrhoids † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Mucositis oral † 1	2/83 (2.41%)	2/57 (3.51%)	0/12 (0.00%)
Nausea † 1	13/83 (15.66%)	11/57 (19.30%)	0/12 (0.00%)
Oral pain † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Rectal hemorrhage † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Retroperitoneal hemorrhage † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Toothache † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Upper gastrointestinal hemorrhage † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Vomiting † 1	5/83 (6.02%)	6/57 (10.53%)	0/12 (0.00%)
General disorders
Chills † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Edema face † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Edema limbs † 1	6/83 (7.23%)	2/57 (3.51%)	0/12 (0.00%)
Edema trunk † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Fatigue † 1	38/83 (45.78%)	15/57 (26.32%)	0/12 (0.00%)
Fever † 1	5/83 (6.02%)	2/57 (3.51%)	0/12 (0.00%)
Flu like symptoms † 1	2/83 (2.41%)	2/57 (3.51%)	0/12 (0.00%)
Gait disturbance † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
General disorders and administration site conditions - Other, specify † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Infusion related reaction † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Localized edema † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Non-cardiac chest pain † 1	2/83 (2.41%)	1/57 (1.75%)	0/12 (0.00%)
Pain † 1	4/83 (4.82%)	7/57 (12.28%)	0/12 (0.00%)
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Infections and infestations
Bronchial infection † 1	2/83 (2.41%)	1/57 (1.75%)	0/12 (0.00%)
Infections and infestations - Other, specify † 1	1/83 (1.20%)	2/57 (3.51%)	0/12 (0.00%)
Lung infection † 1	2/83 (2.41%)	3/57 (5.26%)	0/12 (0.00%)
Papulopustular rash † 1	2/83 (2.41%)	1/57 (1.75%)	0/12 (0.00%)
Rash pustular † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Sinusitis † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Skin infection † 1	2/83 (2.41%)	4/57 (7.02%)	0/12 (0.00%)
Soft tissue infection † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Upper respiratory infection † 1	5/83 (6.02%)	4/57 (7.02%)	0/12 (0.00%)
Urinary tract infection † 1	1/83 (1.20%)	3/57 (5.26%)	0/12 (0.00%)
Vaginal infection † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Injury, poisoning and procedural complications
Ankle fracture † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Bruising † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Fall † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Fracture † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Hip fracture † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Injury, poisoning and procedural complications - Other, specify † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Spinal fracture † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Spinal fracture † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Vascular access complication † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Investigations
Alanine aminotransferase increased † 1	9/83 (10.84%)	6/57 (10.53%)	0/12 (0.00%)
Alkaline phosphatase increased † 1	4/83 (4.82%)	2/57 (3.51%)	0/12 (0.00%)
Aspartate aminotransferase increased † 1	8/83 (9.64%)	6/57 (10.53%)	0/12 (0.00%)
Blood bilirubin increased † 1	3/83 (3.61%)	0/57 (0.00%)	0/12 (0.00%)
CD4 lymphocytes decreased † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Creatinine increased † 1	5/83 (6.02%)	2/57 (3.51%)	0/12 (0.00%)
Investigations - Other, specify † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Lipase increased † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Lymphocyte count decreased † 1	3/83 (3.61%)	1/57 (1.75%)	0/12 (0.00%)
Neutrophil count decreased † 1	1/83 (1.20%)	2/57 (3.51%)	0/12 (0.00%)
Platelet count decreased † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Weight gain † 1	5/83 (6.02%)	1/57 (1.75%)	0/12 (0.00%)
Weight loss † 1	2/83 (2.41%)	5/57 (8.77%)	0/12 (0.00%)
Metabolism and nutrition disorders
Acidosis † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Anorexia † 1	7/83 (8.43%)	7/57 (12.28%)	0/12 (0.00%)
Dehydration † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Glucose intolerance † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Hypercalcemia † 1	3/83 (3.61%)	1/57 (1.75%)	0/12 (0.00%)
Hyperglycemia † 1	10/83 (12.05%)	10/57 (17.54%)	0/12 (0.00%)
Hyperkalemia † 1	6/83 (7.23%)	5/57 (8.77%)	0/12 (0.00%)
Hypoalbuminemia † 1	1/83 (1.20%)	3/57 (5.26%)	0/12 (0.00%)
Hypokalemia † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Hyponatremia † 1	7/83 (8.43%)	6/57 (10.53%)	0/12 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	7/83 (8.43%)	11/57 (19.30%)	0/12 (0.00%)
Arthritis † 1	4/83 (4.82%)	0/57 (0.00%)	0/12 (0.00%)
Back pain † 1	13/83 (15.66%)	3/57 (5.26%)	0/12 (0.00%)
Bone pain † 1	2/83 (2.41%)	1/57 (1.75%)	0/12 (0.00%)
Chest wall pain † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Flank pain † 1	0/83 (0.00%)	2/57 (3.51%)	0/12 (0.00%)
Generalized muscle weakness † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Muscle weakness lower limb † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Muscle weakness upper limb † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Musculoskeletal and connective tissue disorder - Other, specify † 1	1/83 (1.20%)	2/57 (3.51%)	0/12 (0.00%)
Myalgia † 1	2/83 (2.41%)	4/57 (7.02%)	0/12 (0.00%)
Neck pain † 1	2/83 (2.41%)	1/57 (1.75%)	0/12 (0.00%)
Pain in extremity † 1	11/83 (13.25%)	5/57 (8.77%)	0/12 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy † 1	0/83 (0.00%)	2/57 (3.51%)	0/12 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify † 1	2/83 (2.41%)	3/57 (5.26%)	0/12 (0.00%)
Nervous system disorders
Cognitive disturbance † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Dizziness † 1	2/83 (2.41%)	3/57 (5.26%)	0/12 (0.00%)
Dysgeusia † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Facial muscle weakness † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Facial nerve disorder † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Headache † 1	7/83 (8.43%)	11/57 (19.30%)	0/12 (0.00%)
Intracranial hemorrhage † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Nervous system disorders - Other, specify † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Neuralgia † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Paresthesia † 1	0/83 (0.00%)	2/57 (3.51%)	0/12 (0.00%)
Peripheral motor neuropathy † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Peripheral sensory neuropathy † 1	2/83 (2.41%)	1/57 (1.75%)	0/12 (0.00%)
Seizure † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Syncope † 1	0/83 (0.00%)	2/57 (3.51%)	0/12 (0.00%)
Vasovagal reaction † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Psychiatric disorders
Anxiety † 1	2/83 (2.41%)	2/57 (3.51%)	0/12 (0.00%)
Confusion † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Depression † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Insomnia † 1	5/83 (6.02%)	2/57 (3.51%)	0/12 (0.00%)
Personality change † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Psychiatric disorders - Other, specify † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Hematuria † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Renal and urinary disorders - Other, specify † 1	2/83 (2.41%)	3/57 (5.26%)	0/12 (0.00%)
Urinary frequency † 1	2/83 (2.41%)	1/57 (1.75%)	0/12 (0.00%)
Urinary retention † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Urinary tract pain † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Urinary urgency † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Uterine hemorrhage † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Vaginal inflammation † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis † 1	4/83 (4.82%)	1/57 (1.75%)	0/12 (0.00%)
Bronchial obstruction † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Bronchopulmonary hemorrhage † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Cough † 1	12/83 (14.46%)	9/57 (15.79%)	0/12 (0.00%)
Dyspnea † 1	13/83 (15.66%)	2/57 (3.51%)	0/12 (0.00%)
Hiccups † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Hypoxia † 1	2/83 (2.41%)	1/57 (1.75%)	0/12 (0.00%)
Nasal congestion † 1	4/83 (4.82%)	2/57 (3.51%)	0/12 (0.00%)
Pleural effusion † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Pneumonitis † 1	3/83 (3.61%)	2/57 (3.51%)	0/12 (0.00%)
Productive cough † 1	3/83 (3.61%)	0/57 (0.00%)	0/12 (0.00%)
Pulmonary hypertension † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Respiratory failure † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Respiratory, thoracic and mediastinal disorders - Other, specify † 1	3/83 (3.61%)	1/57 (1.75%)	0/12 (0.00%)
Sinus disorder † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Sleep apnea † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Sneezing † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Sore throat † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Tracheal fistula † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Voice alteration † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Wheezing † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Skin and subcutaneous tissue disorders
Bullous dermatitis † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Dry skin † 1	4/83 (4.82%)	2/57 (3.51%)	0/12 (0.00%)
Pain of skin † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Palmar-plantar erythrodysesthesia syndrome † 1	2/83 (2.41%)	0/57 (0.00%)	0/12 (0.00%)
Photosensitivity † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Pruritus † 1	13/83 (15.66%)	11/57 (19.30%)	0/12 (0.00%)
Rash acneiform † 1	5/83 (6.02%)	1/57 (1.75%)	0/12 (0.00%)
Rash maculo-papular † 1	8/83 (9.64%)	7/57 (12.28%)	0/12 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify † 1	9/83 (10.84%)	5/57 (8.77%)	0/12 (0.00%)
Vascular disorders
Hematoma † 1	1/83 (1.20%)	0/57 (0.00%)	0/12 (0.00%)
Hot flashes † 1	2/83 (2.41%)	2/57 (3.51%)	0/12 (0.00%)
Hypertension † 1	1/83 (1.20%)	1/57 (1.75%)	0/12 (0.00%)
Lymphedema † 1	0/83 (0.00%)	1/57 (1.75%)	0/12 (0.00%)
Thromboembolic event † 1	1/83 (1.20%)	3/57 (5.26%)	0/12 (0.00%)
1 Term from vocabulary, CTCAE (4.0); † 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 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

• Name/Title: Toni K Choueiri, MD
• Organization: Dana Farber Cancer Institute
• Phone: (617) 632-5456
• EMail: toni_choueiri@dfci.harvard.edu

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

Bootsma M, McKay RR, Emamekhoo H, Bade RM, Schehr JL, Mannino MC, Singh A, Wolfe SK, Schultz ZD, Sperger J, Xie W, Signoretti S, Kyriakopoulos CE, Kosoff D, Abel EJ, Helzer KT, Rydzewski N, Bakhtiar H, Shi Y, Blitzer G, Bassetti M, Floberg J, Yu M, Sethakorn N, Sharifi M, Harari PM, Choueiri TK, Lang JM, Zhao SG. Longitudinal Molecular Profiling of Circulating Tumor Cells in Metastatic Renal Cell Carcinoma. J Clin Oncol. 2022 Nov 1;40(31):3633-3641. doi: 10.1200/JCO.22.00219. Epub 2022 May 26.

Bade RM, Schehr JL, Emamekhoo H, Gibbs BK, Rodems TS, Mannino MC, Desotelle JA, Heninger E, Stahlfeld CN, Sperger JM, Singh A, Wolfe SK, Niles DJ, Arafat W, Steinharter JA, Jason Abel E, Beebe DJ, Wei XX, McKay RR, Choueri TK, Lang JM. Development and initial clinical testing of a multiplexed circulating tumor cell assay in patients with clear cell renal cell carcinoma. Mol Oncol. 2021 Sep;15(9):2330-2344. doi: 10.1002/1878-0261.12931. Epub 2021 Mar 3.

McKay RR, McGregor BA, Xie W, Braun DA, Wei X, Kyriakopoulos CE, Zakharia Y, Maughan BL, Rose TL, Stadler WM, McDermott DF, Harshman LC, Choueiri TK. Optimized Management of Nivolumab and Ipilimumab in Advanced Renal Cell Carcinoma: A Response-Based Phase II Study (OMNIVORE). J Clin Oncol. 2020 Dec 20;38(36):4240-4248. doi: 10.1200/JCO.20.02295. Epub 2020 Oct 27.

• Responsible Party: Toni Choueiri, MD, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT03203473
• Other Study ID Numbers: 17-064
• First Submitted: May 25, 2017
• First Posted: June 29, 2017
• Results First Submitted: March 1, 2022
• Results First Posted: April 25, 2022
• Last Update Posted: May 17, 2023