Clinical trial NCT02996110: A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Official title: A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR) Per Investigator
timeFrame: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
measure: Median Duration of Response (DOR) Per Investigator
timeFrame: 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)
measure: Progression Free Survival Rate (PFSR) at 24 Weeks.
timeFrame: 24 weeks after first treatment dose.
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation
timeFrame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
measure: Number of Participants Who Died
timeFrame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
measure: Number of Participants With Abnormal Thyroid Test Results - Track 1
timeFrame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
measure: Number of Participants With Abnormal Thyroid Test Results - Track 2
timeFrame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
measure: Number of Participants With Abnormal Hepatic Test Results - Track 1
timeFrame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
measure: Number of Participants With Abnormal Hepatic Test Results - Track 2
timeFrame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Local Institution - 0037
state: Connecticut
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Augusta
country: United States
facility: Local Institution - 0031
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0006
state: Illinois
city: Baltimore
country: United States
facility: Local Institution - 0007
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Local Institution - 0011
state: Michigan
city: Saint Louis
country: United States
facility: Local Institution - 0008
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Local Institution - 0005
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0043
state: North Carolina
city: Columbus
country: United States
facility: Local Institution - 0014
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Allentown
country: United States
facility: Local Institution - 0002
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Local Institution - 0025
state: Tennessee
city: Dallas
country: United States
facility: Ut Southwestern Medical Center
state: Texas
city: Charlottesville
country: United States
facility: Local Institution - 0024
state: Virginia
city: Seattle
country: United States
facility: University of Washington - Seattle Cancer Care Alliance
state: Washington
city: Westmead
country: Australia
facility: Local Institution - 0032
state: New South Wales
city: Bentleigh
country: Australia
facility: Monash Medical Centre Clayton
state: Victoria
city: Linz
country: Austria
facility: Local Institution - 0044
state: Oberösterreich
city: Hamilton
country: Canada
facility: Local Institution - 0038
state: Ontario
city: Oshawa
country: Canada
facility: Local Institution - 0029
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0035
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0034
state: Quebec
city: Québec
country: Canada
facility: Local Institution - 0030
state: Quebec
city: Haifa
country: Israel
facility: Local Institution
city: Ramat Gan
country: Israel
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution - 0010
city: Napoli
country: Italy
facility: Local Institution - 0012
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.