A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (FRACTION-RCC)
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ClinicalTrials.gov Identifier: NCT02996110 |
Recruitment Status :
Active, not recruiting
First Posted : December 19, 2016
Last Update Posted : March 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer | Biological: Nivolumab Biological: Ipilimumab Biological: Relatlimab Drug: BMS-986205 Drug: BMS-813160 | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab
|
Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
Biological: Ipilimumab Specified Dose on Specified Days
Other Names:
|
Experimental: Nivolumab + Relatlimab
Nivolumab + Relatlimab
|
Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
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:
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:
Drug: BMS-813160 Specified Dose on Specified Days |
- 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 ]
- 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 ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |