Advanced Cancer Clinical Trial
Official title:
A Phase 3 Trial of Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer After Platinum-Based Chemotherapy (BRAVA)
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.
The purpose of this Phase 3 trial is to demonstrate prolongation of OS in patients treated with BAL as compared to IC chemotherapy. This Phase 3 trial is an open-label, randomized study with single-agent BAL or 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. Population: Patients with recurrent, unresectable, or metastatic cervical cancer who have progressed after receiving at least 1 prior line of platinum-containing chemotherapy with or without bevacizumab. In this study, > 50% of patients will have received prior treatment with bevacizumab, which will be determined prior to enrollment. Stratification - Histology (squamous cell carcinoma [SCC] vs adenocarcinoma [AC] or adenosquamous carcinoma [ASC]) - Region of the world (United States or Europe Union or Australia vs other countries) - Eastern Cooperative Oncology Group (ECOG) status 0 vs 1 Randomization • 2:1, BAL: IC chemotherapy Approximately 486 patients will be enrolled and randomized with 2:1 allocation between the BAL and IC chemotherapy arms. ;
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