Trial Outcomes & Findings for A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma (NCT NCT04088500)

Last Updated: 2023-01-10

Results Overview

Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 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 (PD), taking as reference the smallest sum diameters while on study.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

From first dose up to approximately 14 months

Results posted on

2023-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	NIVO 3 + IPI 1 Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	NIVO 3 + IPI 1 Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Overall Study Reason unknown	1
Overall Study Participant withdrew consent	1
Overall Study Disease progression	3

Baseline Characteristics

A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NIVO 3 + IPI 1 n=5 Participants Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Age, Continuous	62.2 Years STANDARD_DEVIATION 11.0 • n=5 Participants
Age, Customized < 65 years	2 Participants n=5 Participants
Age, Customized >= 65 AND < 75 years	3 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose up to approximately 14 months

Population: All treated participants

Outcome measures

Outcome measures
Measure	NIVO 3 + IPI 1 n=5 Participants Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Disease Control Rate (DCR)	60.0 Percentage of participants Interval 14.7 to 94.7

SECONDARY outcome

Timeframe: From first dose to the date of death from any cause (up to approximately 14 months)

Population: All treated participants

Overall Survival (OS) is defined as the time from first dose to the date of death from any cause. For participants that are alive, their survival time will be censored at the date of last contact ("last known alive date"). OS will be censored for participants at the date of first dose if they were treated but had no follow-up.

Outcome measures

Outcome measures
Measure	NIVO 3 + IPI 1 n=5 Participants Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Overall Survival (OS)	NA Months Interval 11.01 to Insufficient number of participants with events

SECONDARY outcome

Timeframe: From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months)

Population: All treated participants

Overall Response Rate (ORR) is defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 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.

Outcome measures

Outcome measures
Measure	NIVO 3 + IPI 1 n=5 Participants Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Overall Response Rate (ORR)	0.0 Percentage of participants Interval 0.0 to 52.2

SECONDARY outcome

Timeframe: From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)

Population: All treated participants with CR or PR

Duration of Response (DOR) is defined as the time between the date of first documented response (complete response (CR) or partial response (PR)) to the date of the first documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)

Population: All treated participants

Progression Free Survival (PFS) is defined as the time between the date of first dose and the first date of documented progression, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Progression is defined as 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).

Outcome measures

Outcome measures
Measure	NIVO 3 + IPI 1 n=5 Participants Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Progression Free Survival (PFS)	NA Months Interval 4.6 to Insufficient number of participants with events

SECONDARY outcome

Timeframe: From first dose to the first confirmed documented response (up to approximately 14 months)

Population: All treated participants with CR or PR

Time to Objective Response (TTR) is defined as the time between the date of the first dose and the first confirmed documented response (complete response (CR) or partial response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose and 100 days after lost dose (up to approximately 14 months)

Population: All treated participants

The number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	NIVO 3 + IPI 1 n=5 Participants Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
The Number of Participants Experiencing Adverse Events (AEs)	5 Participants

Adverse Events

NIVO 3 + IPI 1

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	NIVO 3 + IPI 1 n=5 participants at risk Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Metabolism and nutrition disorders HYPOVOLAEMIA	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Renal and urinary disorders HAEMATURIA	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).

Other adverse events

Other adverse events
Measure	NIVO 3 + IPI 1 n=5 participants at risk Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W).
Blood and lymphatic system disorders ANAEMIA	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Ear and labyrinth disorders VERTIGO	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Gastrointestinal disorders ABDOMINAL PAIN	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Gastrointestinal disorders ABDOMINAL PAIN LOWER	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Gastrointestinal disorders ASCITES	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Gastrointestinal disorders DIARRHOEA	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Gastrointestinal disorders VOMITING	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
General disorders FATIGUE	40.0% 2/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
General disorders OEDEMA PERIPHERAL	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Injury, poisoning and procedural complications CONTUSION	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Investigations ALANINE AMINOTRANSFERASE INCREASED	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Investigations WEIGHT DECREASED	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Metabolism and nutrition disorders DECREASED APPETITE	40.0% 2/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Musculoskeletal and connective tissue disorders FLANK PAIN	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Renal and urinary disorders ACUTE KIDNEY INJURY	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Renal and urinary disorders HAEMATURIA	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Respiratory, thoracic and mediastinal disorders COUGH	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	40.0% 2/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	20.0% 1/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Skin and subcutaneous tissue disorders PRURITUS	40.0% 2/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Skin and subcutaneous tissue disorders RASH	40.0% 2/5 • All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER