drugset / Trial / NCT04800978
Combination of Durvalumab and BVAC-C in Patients With HPV 16 or 18 Positive Cervical Cancer Failure to First-Line Platinum-based Chemotherapy
Phase 2
Unknown
37 enrolled
Samsung Medical Center
Asan Medical Center · collabNational Cancer Center, Korea · collabSeoul National University Bundang Hospital · collabSeoul National University Hospital · collabSeverance Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an exploratory, open label, multi-center trial to evaluate the safety and efficacy of combination of durvalumab with BVAC-C in patients with cervical cancer refractory to or relapse after platinum-based first-line chemotherapy with safety lead-in phase. The study consists of 2 parts: part A, a safety lead-in phase, and part B, an exploratory safety and efficacy evaluation phase. Part A will be conducted as a 3+3 dose escalation manner, and part B will be conducted as a non-randomized single arm study. •Part A: Open-labeled; 3+3 dose-escalation; Multi-center; safety lead-in phase •Part B: Open-labeled; Non-randomized, Single arm; Multi-center, efficacy evaluation phase
Timeline
- Start
- 2021-06-14
- Primary completion
- 2024-08-31
- Completion
- 2024-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BVAC-C | Vaccine | 1e+08 cells | — |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | — |