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A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

NCT05529316 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-16

No results posted yet for this study

Summary

This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.

Conditions

Interventions

DRUG

Botensilimab

An anti-CTLA-4 monoclonal antibody

DRUG

Balstilimab

An anti-PD-1 monoclonal antibody

Sponsors & Collaborators

  • 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
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • France
  • Germany
  • Italy
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

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 NCT05529316 on ClinicalTrials.gov