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A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (FRACTION-RCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02996110
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 15, 2016
First Posted Date  ICMJE December 19, 2016
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE January 17, 2017
Estimated Primary Completion Date January 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • Objective Response Rate (ORR) [ Time Frame: Up to 24 weeks ]
  • Duration of Response (DOR) [ Time Frame: Up to 24 weeks ]
  • Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Safety as measured by incidence of AEs (Adverse Events) [ Time Frame: Up to 2 years ]
  • Safety as measured by incidence of SAEs (Serious Adverse Events) [ Time Frame: Up to 2 years ]
  • Tolerability as measured by incidence of AEs [ Time Frame: Up to 2 years ]
  • Tolerability as measured by SAEs [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • Safety as measured by incidence of AEs (Adverse Events) [ Time Frame: Up to 268 days ]
  • Safety as measured by incidence of SAEs (Serious Adverse Events) [ Time Frame: Up to 268 days ]
  • Tolerability as measured by incidence of AEs [ Time Frame: Up to 268 days ]
  • Tolerability as measured by SAEs [ Time Frame: Up to 268 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Official Title  ICMJE A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Other Names:
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Other Names:
    • BMS-734016
    • Yervoy
  • Biological: Relatlimab
    Other Name: BMS-986016
  • Drug: BMS-986205
  • Drug: BMS-813160
Study Arms  ICMJE
  • Active Comparator: Nivolumab + Ipilimumab
    Nivolumab + Ipilimumab
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Nivolumab + Relatlimab
    Nivolumab + Relatlimab
    Interventions:
    • Biological: Nivolumab
    • Biological: Relatlimab
  • Experimental: Nivolumab + BMS-986205
    Nivolumab + BMS-986205
    Interventions:
    • Biological: Nivolumab
    • Drug: BMS-986205
  • Experimental: Nivolumab + BMS-813160
    Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
    Interventions:
    • Biological: Nivolumab
    • Drug: BMS-813160
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2017)
200
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
650
Estimated Study Completion Date  ICMJE January 18, 2023
Estimated Primary Completion Date January 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Israel,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02996110
Other Study ID Numbers  ICMJE CA018-005
2016-003082-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP