NCT05033132

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

An Open-label, Multicenter Phase II Study Evaluating Balstilimab Alone or Balstilimab in Combination With Zalifrelimab in Patients With Advanced Cervical Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Cervical Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2021-09-02
• Last updated: 2024-03-28

Locations

43 sites across 1 country: China

Regulatory

• FDA-regulated drug study