drugset / Trial / NCT04042116
A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
Phase 1/2
Suspended
227 enrolled
Clovis Oncology, Inc.
Bristol-Myers Squibb · collabEuropean Network of Gynaecological Oncological Trial Groups (ENGOT) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect)
Timeline
- Start
- 2019-07-29
- Primary completion
- 2023-07
- Completion
- 2024-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lucitanib | Small molecule | 6 mg | Oral |
| Subject | Lucitanib | Small molecule | 10 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |