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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02996110




Registration number
NCT02996110
Ethics application status
Date submitted
15/12/2016
Date registered
19/12/2016
Date last updated
19/12/2022

Titles & IDs
Public title
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Scientific title
A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
Secondary ID [1] 0 0
2016-003082-26
Secondary ID [2] 0 0
CA018-005
Universal Trial Number (UTN)
Trial acronym
FRACTION-RCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Ipilimumab
Treatment: Other - Relatlimab
Treatment: Drugs - BMS-986205
Treatment: Drugs - BMS-813160

Active comparator: Nivolumab + Ipilimumab - Nivolumab + Ipilimumab

Experimental: Nivolumab + Relatlimab - Nivolumab + Relatlimab

Experimental: Nivolumab + BMS-986205 - Nivolumab + BMS-986205

Experimental: Nivolumab + BMS-813160 - Nivolumab + BMS-813160 (CCR2/5 dual antagonist)


Treatment: Other: Nivolumab
Specified Dose on Specified Days

Treatment: Other: Ipilimumab
Specified Dose on Specified Days

Treatment: Other: Relatlimab
Specified Dose on Specified Days

Treatment: Drugs: BMS-986205
Specified Dose on Specified Days

Treatment: Drugs: BMS-813160
Specified Dose on Specified Days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Per Investigator
Timepoint [1] 0 0
From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
Primary outcome [2] 0 0
Median Duration of Response (DOR) Per Investigator
Timepoint [2] 0 0
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 outcome [3] 0 0
Progression Free Survival Rate (PFSR) at 24 Weeks.
Timepoint [3] 0 0
24 weeks after first treatment dose.
Secondary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Secondary outcome [2] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Secondary outcome [3] 0 0
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Timepoint [3] 0 0
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Secondary outcome [4] 0 0
Number of Participants Who Died
Timepoint [4] 0 0
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Secondary outcome [5] 0 0
Number of Participants With Abnormal Thyroid Test Results - Track 1
Timepoint [5] 0 0
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Secondary outcome [6] 0 0
Number of Participants With Abnormal Thyroid Test Results - Track 2
Timepoint [6] 0 0
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Secondary outcome [7] 0 0
Number of Participants With Abnormal Hepatic Test Results - Track 1
Timepoint [7] 0 0
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Secondary outcome [8] 0 0
Number of Participants With Abnormal Hepatic Test Results - Track 2
Timepoint [8] 0 0
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/11/2021
Sample size
Target
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0032 - Westmead
Recruitment hospital [2] 0 0
Monash Medical Centre Clayton - Bentleigh
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3165 - Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Austria
State/province [19] 0 0
Oberösterreich
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Israel
State/province [23] 0 0
Ramat Gan
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Napoli

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT02996110
Trial related presentations / publications
Choueiri TK, Kluger H, George S, Tykodi SS, Kuzel TM, Perets R, Nair S, Procopio G, Carducci MA, Castonguay V, Folefac E, Lee CH, Hotte SJ, Miller WH Jr, Saggi SS, Lee CW, Desilva H, Bhagavatheeswaran P, Motzer RJ, Escudier B. FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy. J Immunother Cancer. 2022 Nov;10(11):e005780. doi: 10.1136/jitc-2022-005780.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02996110