A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma

Advanced Cancer Clinical Trial

— FRACTION-RCC  

Official title:

A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996110
• Other study ID #: CA018-005
• Secondary ID: 2016-003082-26
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2017
• Est. completion date: November 23, 2021

Study information

• Verified date: November 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Advanced Cancer
• Carcinoma, Renal Cell

Intervention

Biological:
• Nivolumab
Specified Dose on Specified Days
• Ipilimumab
Specified Dose on Specified Days
• Relatlimab
Specified Dose on Specified Days

Drug:
• BMS-986205
Specified Dose on Specified Days
• BMS-813160
Specified Dose on Specified Days

Locations

Country	Name	City	State
Australia	Monash Medical Centre Clayton	Bentleigh	Victoria
Australia	Local Institution - 0032	Westmead	New South Wales
Austria	Local Institution - 0044	Linz	Oberösterreich
Canada	Local Institution - 0038	Hamilton	Ontario
Canada	Local Institution - 0034	Montreal	Quebec
Canada	Local Institution - 0029	Oshawa	Ontario
Canada	Local Institution - 0030	Québec	Quebec
Canada	Local Institution - 0035	Toronto	Ontario
Israel	Local Institution	Haifa
Israel	Local Institution	Ramat Gan
Italy	Local Institution - 0010	Milano
Italy	Local Institution - 0012	Napoli
United States	Local Institution - 0002	Allentown	Pennsylvania
United States	Local Institution - 0031	Augusta	Georgia
United States	Local Institution - 0007	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Hollings Cancer Center	Charleston	South Carolina
United States	Local Institution - 0043	Charlotte	North Carolina
United States	Local Institution - 0024	Charlottesville	Virginia
United States	Local Institution - 0006	Chicago	Illinois
United States	Local Institution - 0014	Columbus	Ohio
United States	Ut Southwestern Medical Center	Dallas	Texas
United States	Local Institution - 0011	Detroit	Michigan
United States	Local Institution - 0025	Nashville	Tennessee
United States	Local Institution - 0037	New Haven	Connecticut
United States	Local Institution - 0005	New York	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	Local Institution - 0008	Saint Louis	Missouri
United States	University of Washington - Seattle Cancer Care Alliance	Seattle	Washington
United States	Local Institution	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) Per Investigator	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.	From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
Primary	Median Duration of Response (DOR) Per Investigator	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 method	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)
Primary	Progression Free Survival Rate (PFSR) at 24 Weeks.	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 formula	24 weeks after first treatment dose.
Secondary	Number of Participants With Adverse Events (AEs)	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.	From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Secondary	Number of Participants With Serious Adverse Events (SAEs)	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	From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Secondary	Number of Participants With Adverse Events (AEs) Leading to Discontinuation	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.	From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Secondary	Number of Participants Who Died	Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.	From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Secondary	Number of Participants With Abnormal Thyroid Test Results - Track 1	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.	From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Secondary	Number of Participants With Abnormal Thyroid Test Results - Track 2	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	From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Secondary	Number of Participants With Abnormal Hepatic Test Results - Track 1	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	From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Secondary	Number of Participants With Abnormal Hepatic Test Results - Track 2	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	From first dose to 30 days after last dose of study therapy (approximately 108 weeks)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting