A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
- Conditions
- Advanced Cancer
- Interventions
- Registration Number
- NCT02996110
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- Advanced Renal Cell Carcinoma
- Must have at least 1 lesion with measurable disease
- Life expectancy of at least 3 months
- Karnofsky Performance Status (KPS) must be =>70%
- Patients/subjects with suspected or known central nervous system metastases unless adequately treated
- Patients/subjects with autoimmune disease
- Patients/subjects who need daily oxygen therapy
Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab + Ipilimumab Nivolumab Nivolumab + Ipilimumab Nivolumab + Ipilimumab Ipilimumab Nivolumab + Ipilimumab Nivolumab + Relatlimab Nivolumab Nivolumab + Relatlimab Nivolumab + Relatlimab Relatlimab Nivolumab + Relatlimab Nivolumab + BMS-986205 Nivolumab Nivolumab + BMS-986205 Nivolumab + BMS-986205 BMS-986205 Nivolumab + BMS-986205 Nivolumab + BMS-813160 Nivolumab Nivolumab + BMS-813160 (CCR2/5 dual antagonist) Nivolumab + BMS-813160 BMS-813160 Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
- Primary Outcome Measures
Name Time Method Median Duration of Response (DOR) Per Investigator From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks) Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.
Complete Response (CR) is the 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) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Median computed using Kaplan -Meier methodProgression Free Survival Rate (PFSR) at 24 Weeks. 24 weeks after first treatment dose. The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Progressive Disease (PD) is 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).
Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formulaObjective Response Rate (ORR) Per Investigator From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks) ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).
BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.
For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.
CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 mm.
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.
CR+PR, confidence interval based on Clopper and Pearson method.
- Secondary Outcome Measures
Name Time Method Number of Participants With Abnormal Thyroid Test Results - Track 1 From first dose to 30 days after last dose of study therapy (approximately 108 weeks) The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
Number of Participants With Abnormal Hepatic Test Results - Track 2 From first dose to 30 days after last dose of study therapy (approximately 108 weeks) The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Number of Participants With Adverse Events (AEs) Leading to Discontinuation From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) An Adverse Event (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.
Number of Participants Who Died From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.
Number of Participants With Adverse Events (AEs) From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) An Adverse Event (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.
Number of Participants With Serious Adverse Events (SAEs) From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization
Number of Participants With Abnormal Thyroid Test Results - Track 2 From first dose to 30 days after last dose of study therapy (approximately 108 weeks) The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Number of Participants With Abnormal Hepatic Test Results - Track 1 From first dose to 30 days after last dose of study therapy (approximately 108 weeks) The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Trial Locations
- Locations (30)
Local Institution - 0044
🇦🇹Linz, Oberösterreich, Austria
Local Institution - 0043
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0007
🇺🇸Baltimore, Maryland, United States
Local Institution - 0011
🇺🇸Detroit, Michigan, United States
Local Institution
🇮🇱Ramat Gan, Israel
Local Institution - 0031
🇺🇸Augusta, Georgia, United States
Local Institution - 0008
🇺🇸Saint Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Local Institution - 0014
🇺🇸Columbus, Ohio, United States
Local Institution - 0002
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0024
🇺🇸Charlottesville, Virginia, United States
Local Institution - 0032
🇦🇺Westmead, New South Wales, Australia
Ut Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Local Institution - 0029
🇨🇦Oshawa, Ontario, Canada
Local Institution - 0038
🇨🇦Hamilton, Ontario, Canada
Monash Medical Centre Clayton
🇦🇺Bentleigh, Victoria, Australia
Local Institution - 0034
🇨🇦Montreal, Quebec, Canada
Local Institution - 0035
🇨🇦Toronto, Ontario, Canada
Local Institution - 0030
🇨🇦Québec, Quebec, Canada
Local Institution - 0012
🇮🇹Napoli, Italy
Local Institution - 0010
🇮🇹Milano, Italy
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Local Institution - 0037
🇺🇸New Haven, Connecticut, United States
Local Institution - 0006
🇺🇸Chicago, Illinois, United States
University of Washington - Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Local Institution - 0005
🇺🇸New York, New York, United States
Local Institution - 0025
🇺🇸Nashville, Tennessee, United States