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A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)

NCT03495882 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-08-11

Study results available
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Summary

This is a Phase 1/2, open-label study of zalifrelimab (AGEN1884) in combination with balstilimab (AGEN2034) in participants with locally advanced, recurrent and/or metastatic solid tumors including cervical cancer. Balstilimab is a novel, fully human monoclonal immunoglobulin G4 antibody, designed to block program cell death-1 (PD-1). Zalifrelimab is a novel, fully human monoclonal immunoglobulin G1 antibody, designed to block cytotoxic T-lymphocyte antigen-4 (CTLA-4).

Conditions

Interventions

DRUG

Zalifrelimab

Zalifrelimab was administered over 30 minutes and following the infusion of balstilimab.

DRUG

Balstilimab

Balstilimab infusion was administered over 30 minutes.

Sponsors & Collaborators

  • Agenus Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Agenus Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2022-07-15
Completion
2022-07-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Georgia
  • Hungary
  • Moldova
  • Poland
  • Spain
  • Ukraine

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 NCT03495882 on ClinicalTrials.gov