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A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer

NCT05033132 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-03-28

No results posted yet for this study

Summary

This is an open-label, multi-center Phase II clinical trial to assess the efficacy, safety, and pharmacokinetics of Balstilimab (Treatment Arm 1 - monotherapy) or in combination with Zalifrelimab (Treatment Arm 2 - combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy.

Conditions

Interventions

DRUG

Balstilimab

Anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody

DRUG

Balstilimab + Zalifrelimab

An anti-PD-1 monoclonal antibody in combination with a cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • 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
2021-10-01
Primary Completion
2024-12-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05033132 on ClinicalTrials.gov