Clinical trial · Interventional
A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
NCT03606174CI-TRIAL-00069071terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to sponsor decision / portfolio prioritization, and not due to safety reasons.
Summary
Brief summary (as posted)
The study will evaluate the clinical activity of PD-(L)1 Checkpoint Inhibitor regimens in combination with the investigational agent sitravatinib in patients with advanced or metastatic urothelial carcinoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma Bladder | — | UNRESOLVED | — |
| Urothelial Carcinoma of the Renal Pelvis and Ureter | Renal Pelvis and Ureter Urothelial Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma Ureter | — | UNRESOLVED | — |
| Urothelial Carcinoma Urethra | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enfortumab vedotin | Drug | Enfortumab Vedotin | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Sitravatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Patients previously treated with checkpoint inhibitor and platinum-based chemotherapy. Nivolumab over 30 min IV infusion (240 mg IV every 2 weeks or 480 mg every 4 weeks) and sitravatinib 120 mg orally once per day continuously in 28-day cycles.
- interventionNames
- Drug: Sitravatinib
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Patients previously treated with checkpoint inhibitor, but ineligible for platinum-based chemotherapy. Nivolumab over 30 min IV infusion (240 mg IV every 2 weeks or 480 mg every 4 weeks) and sitravatinib 120 mg orally once per day continuously in 28-day cycles.
- interventionNames
- Drug: Sitravatinib
- Drug: Nivolumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of urothelial carcinoma * Adequate bone marrow and organ function Exclusion Criteria: * Uncontrolled tumor in the brain * Unacceptable toxicity with prior checkpoint inhibitor * Impaired heart function
References
Publications (0)
Data not yet available
No reference posted for this study.