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

ClinicalTrials.gov ID: NCT05529316

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05529316
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: Agenus Inc.; Industry
Enrollment: 150 participants

Conditions and interventions

Conditions

Advanced Melanoma

Interventions

Botensilimab Drug
Balstilimab Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 12, 2022 (Actual)
Primary completion: Apr 27, 2026 (Actual)
Completion: Apr 27, 2026 (Actual)
Last update posted: Oct 19, 2026

2022 – 2026

United States locations

U.S. sites: 7
U.S. states: 6
U.S. cities: 7

Facility	City	State	ZIP	Site status
Scottsdale Healthcare Hospitals DBA HonorHealth	Scottsdale	Arizona	85258	—
Virginia K. Crosson Cancer Center at St. Jude Medical Center	Fullerton	California	92835	—
Providence Saint John's Health Center	Santa Monica	California	90404	—
Yale University School of Medicine - Yale Cancer Center	New Haven	Connecticut	06520-8028	—
Georgetown University Medical Center	Washington D.C.	District of Columbia	20057	—
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	—
John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	07601	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05529316, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 19, 2026 · Synced Nov 14, 2026