NCT04943627

Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)

A Phase 3 Trial of Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer After Platinum-Based Chemotherapy (BRAVA)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Advanced Cancer
• Metastatic Cervical Cancer

Interventions

Type	Name	Description
DRUG	Balstilimab (BAL)	Anti-PD-1 Monoclonal antibody
DRUG	Topotecan	Chemotherapy
DRUG	Vinorelbine	Chemotherapy
DRUG	Gemcitabine	Chemotherapy
DRUG	Irinotecan	Chemotherapy
DRUG	Pemetrexed	Chemotherapy

Timeline

• Start date: 2021-08-02
• Primary completion: 2021-10-22
• Completion: 2021-10-22
• First posted: 2021-06-29
• Last updated: 2022-10-05

Locations

3 sites across 2 countries: United States, Armenia

Regulatory

• FDA-regulated drug study