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

NCT04943627 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-10-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Balstilimab (BAL)

Anti-PD-1 Monoclonal antibody

DRUG

Topotecan

Chemotherapy

DRUG

Vinorelbine

Chemotherapy

DRUG

Gemcitabine

Chemotherapy

DRUG

Irinotecan

Chemotherapy

DRUG

Pemetrexed

Chemotherapy

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Agenus Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Agenus Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2021-10-22
Completion
2021-10-22
FDA Drug
Yes

Countries

  • United States
  • Armenia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943627 on ClinicalTrials.gov