drugset / Trial / NCT04943627
Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)
Phase 3
Withdrawn
Agenus Inc.
European Network of Gynaecological Oncological Trial Groups (ENGOT) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This Phase 3 trial is an open-label, randomized study with single-agent Balstilimab (BAL) or Investigator Choice (IC) chemotherapy (single-agent gemcitabine, irinotecan, pemetrexed, vinorelbine, or topotecan) in patients with recurrent, persistent, or metastatic cervical cancer who have progressed after receiving platinum based chemotherapy.
Timeline
- Start
- 2021-08-02
- Primary completion
- 2021-10-22
- Completion
- 2021-10-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balstilimab | Monoclonal antibody | 300 mg | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Comparator | Topotecan | Small molecule | 1 mg/m2 | Intravenous |
| Comparator | Topotecan | Small molecule | 1.25 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 30 mg/m2 | Intravenous |