Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT05033132
Status:
WITHDRAWN
Last Update Posted:
2024-03-28
First Post:
2021-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer
Sponsor:
Agenus Inc.
Organization:
Study Overview
Official Title:
An Open-label, Multicenter Phase II Study Evaluating Balstilimab Alone or Balstilimab in Combination With Zalifrelimab in Patients With Advanced Cervical Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never initiated.
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: