Clinical trial · Interventional
Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
A Phase 1/1b Study of Sitravatinib in Combination With Nivolumab and Ipilimumab in Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
NCT04518046CI-TRIAL-00077758completedPhase 1ClinicalTrials.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)
Study 516-008 is an open-label Phase 1 dose escalation/Phase 1b dose expansion study evaluating the safety and tolerability, clinical activity, and PK of sitravatinib in combination with nivolumab and ipilimumab for the treatment of ccRCC and potentially other solid tumor types.
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 |
|---|---|---|---|
| Clear-Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Sitravatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation
- description
- Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.
- interventionNames
- Drug: Sitravatinib
- Drug: Nivolumab
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- Phase 1b Dose Escalation Cohort A
- description
- Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment
- interventionNames
- Drug: Sitravatinib
- Drug: Nivolumab
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under consideration) * No prior treatment with systemic therapy (for initial cohorts under consideration) * Adequate bone marrow and organ function Exclusion Criteria: * Known or suspected presence of other cancer * Brain metastases (for initial cohorts under consideration) * Carcinomatous meningitis * Immunocompromising conditions * Impaired heart function * Active or prior documented autoimmune disease
References
Publications (1)
- DERIVEDMsaouel P, Yu K, Yuan Y, Chen J, Yan X, Karki M, Duan F, Sheth RA, Rao P, Sircar K, Shah AY, Zurita AJ, Genovese G, Li M, Yeh CC, Dang M, Han G, Chu Y, Hallin M, Olson P, Yang R, Slavin D, Der-Torossian H, Chin CD, Tannir NM, Wang L, Gao J. Sitravatinib in combination with nivolumab plus ipilimumab in patients with advanced clear cell renal cell carcinoma: a phase 1 trial. Nat Commun. 2025 Jan 10;16(1):578. doi: 10.1038/s41467-024-55642-8. PMID 39794332