NCT05529316

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

A Multicohort, Open Label, Phase 2 Study of Botensilimab (AGEN1181) for Treatment of Advanced Melanoma Refractory to Prior Checkpoint Inhibitor Therapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase 2 study will enroll up to approximately 220 evaluable adult participants with a histologically confirmed diagnosis of either Stage III (unresectable) or Stage IV cutaneous melanoma and who have had prior treatments with anti-programmed death (ligand) 1 \[PD-(L)1\]. This study will consist of 2 parts. Part 1 consists of 2 cohorts (Cohorts A and B) that will receive botensilimab monotherapy. In Cohort A, participants refractory to PD-(L)1 will receive botensilimab. In Cohort B, participants refractory to PD-(L)1 and cytotoxic T-lymphocyte antigen 4 (CTLA-4) will receive botensilimab. Part 2 consists of Cohorts A and B that will receive botensilimab combination therapy. In Cohort A, participants refractory to PD-(L)1 will receive botensilimab in combination with balstilimab. In Cohort B, participants refractory to PD-(L)1 and CTLA-4 will receive botensilimab in combination with balstilimab.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Botensilimab	An anti-CTLA-4 monoclonal antibody
DRUG	Balstilimab	An anti-PD-1 monoclonal antibody

Timeline

• Start date: 2022-12-12
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2022-09-07
• Last updated: 2026-01-16

Locations

51 sites across 10 countries: United States, Belgium, Brazil, France, Germany, Italy, Russia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study