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NCT05529316 · ClinicalTrials.gov registry record · Phase 2
A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma
A Phase 2 study of Advanced Melanoma, sponsored by Agenus.
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT05529316: Active Phase 2 study of Advanced Melanoma, sponsored by Agenus.
NCT05529316 is a Phase 2 study of Advanced Melanoma that is active but no longer recruiting, run by Agenus. The registered enrollment target is 150 participants, roughly in line with the 165-participant average among 21 other Advanced Melanoma trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05529316, a Phase 2 study of Advanced Melanoma, is active but no longer recruiting, sponsored by Agenus.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Objective response rate will be determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Conditions Studied
Interventions
- DRUG Balstilimab
- DRUG Botensilimab
Study Locations (20)
Other
- Universitair Ziekenhuis Brussel - Jette
- Oncosite - Centro de Pesquisa Clinica Em Oncologia - Ijuí
- Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho - Jaú
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Porto Alegre
- INCA II - Instituto Nacional de Cancer Jose Alencar Gomes da Silva - Rio de Janeiro
- Hospital Sirio Libanes - São Paulo
- Real e Benemerita Associaçao Portuguesa de Beneficencia - A Beneficencia Portuguesa de Sao Paulo - São Paulo
- Hospital A.C. Camargo Cancer Center - São Paulo
- CHU Amiens Picardie - Hopital Sud - Amiens
- CHU Grenoble-Alpes - Hopital Michallon - La Tronche
- Centre Leon Berard - Lyon
- CHU de Nantes - Nantes
- AP-HP Hopital Saint-Louis - Paris
California
- Virginia K. Crosson Cancer Center at St. Jude Medical Center - Fullerton
- Providence Saint John's Health Center - Santa Monica
Arizona
- Scottsdale Healthcare Hospitals DBA HonorHealth - Scottsdale
Connecticut
- Yale University School of Medicine - Yale Cancer Center - New Haven
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Massachusetts
- Dana-Farber Cancer Institute - Boston
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
What the registry record for NCT05529316 still lists
NCT05529316 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 165-participant average among 21 other Advanced Melanoma trials with a reported enrollment target.
The record links to 1 condition, with Advanced Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Balstilimab is the first listed.
NCT05529316 names 20 study sites across 7 states, led by Other, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05529316 about?
NCT05529316 is a clinical study titled "A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma". 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.
What is the current status of trial NCT05529316?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2022-12-12. Estimated completion is 2028-02.
What conditions does trial NCT05529316 study?
This clinical trial studies the following conditions: Advanced Melanoma.
What interventions are being tested in trial NCT05529316?
The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG).
Who is sponsoring clinical trial NCT05529316?
This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05529316 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05529316's enrollment target sits among peer trials
150 6th of 21 higher than 15 of 21 other Advanced Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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