Clinical trial · Interventional
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
NCT02996110CI-TRIAL-00062748FRACTION-RCCcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-813160 | Drug | — | UNRESOLVED |
| BMS-986205 | Drug | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Relatlimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Nivolumab + Ipilimumab
- description
- Nivolumab + Ipilimumab
- interventionNames
- Biological: Nivolumab
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Nivolumab + Relatlimab
- description
- Nivolumab + Relatlimab
- interventionNames
- Biological: Nivolumab
- Biological: Relatlimab
- type
- EXPERIMENTAL
- label
- Nivolumab + BMS-986205
- description
- Nivolumab + BMS-986205
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChoueiri 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. PMID 36328377