Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02996110
Recruitment Status : Active, not recruiting
First Posted : December 19, 2016
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: Nivolumab Biological: Ipilimumab Biological: Relatlimab Drug: BMS-986205 Drug: BMS-813160 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : February 8, 2022
Estimated Study Completion Date : January 27, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab
 Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified Dose on Specified Days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Nivolumab + Relatlimab
Nivolumab + Relatlimab
 Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Relatlimab
Specified Dose on Specified Days
Other Name: BMS-986016
Experimental: Nivolumab + BMS-986205
Nivolumab + BMS-986205
 Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Specified Dose on Specified Days
Experimental: Nivolumab + BMS-813160
Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
 Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-813160
Specified Dose on Specified Days


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 24 weeks ]
  2. Duration of Response (DOR) [ Time Frame: Up to 24 weeks ]
  3. Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Safety as measured by incidence of AEs (Adverse Events) [ Time Frame: Up to 2 years ]
  2. Safety as measured by incidence of SAEs (Serious Adverse Events) [ Time Frame: Up to 2 years ]
  3. Tolerability as measured by incidence of AEs [ Time Frame: Up to 2 years ]
  4. Tolerability as measured by SAEs [ Time Frame: Up to 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996110


Locations
Show Show 32 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02996110    
Other Study ID Numbers: CA018-005
2016-003082-26 ( EudraCT Number )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: February 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Linrodostat
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors