Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma
NCT05529316 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05529316
The ClinicalTrials.gov registry entry for NCT05529316 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agenus, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05529316 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05529316?
The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05529316?
This trial is sponsored by Agenus, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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