Description:
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
Title
- Brief Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
CA018-005
- SECONDARY ID:
2016-003082-26
- NCT ID:
NCT02996110
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | Opdivo, BMS-936558 | Nivolumab + BMS-813160 |
| Ipilimumab | BMS-734016, Yervoy | Nivolumab + Ipilimumab |
| Relatlimab | BMS-986016 | Nivolumab + Relatlimab |
| BMS-986205 | | Nivolumab + BMS-986205 |
| BMS-813160 | | Nivolumab + BMS-813160 |
Purpose
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 Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab + Ipilimumab | Active Comparator | Nivolumab + Ipilimumab | |
| Nivolumab + Relatlimab | Experimental | Nivolumab + Relatlimab | |
| Nivolumab + BMS-986205 | Experimental | Nivolumab + BMS-986205 | |
| Nivolumab + BMS-813160 | Experimental | Nivolumab + BMS-813160 (CCR2/5 dual antagonist) | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Up to 24 weeks |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Safety as measured by incidence of AEs (Adverse Events) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Safety as measured by incidence of SAEs (Serious Adverse Events) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Tolerability as measured by incidence of AEs |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Tolerability as measured by SAEs |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
June 17, 2020
