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A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment
NCT04526899 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.
Conditions Studied
Interventions
- BIOLOGICAL Cemiplimab
- BIOLOGICAL BNT111
Study Locations (20)
Other
- Border Medical Oncology — East Albury
- Gold Coast Hospital — Southport
- Melanoma Institute Australia — Sydney
- Klinik für Dermatologie, Dermatochirurgie, Allergologie, Klinikum Bremen-Ost, Gesundheitnord GmbH — Bremen
- Universitätsklinikum Essen (AoR) — Essen
- Universitätsklinikum Freiburg, Klinik füer Dermatologie und Venerologie — Freiburg im Breisgau
- Universitätsklinikum Heidelberg — Heidelberg
- Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel Hautkrebszentrum Kiel — Kiel
- Universitätsklinikum Leipzig — Leipzig
- Universitätsmedizin der Johannes Gutenberg Universität Mainz KoeR — Mainz
- Universitätsklinikum Mannheim GmbH — Mannheim
- Klinikum Nürnberg Nord — Nuremberg
- University Hospital Tübingen — Tübingen
- Klinikum der Julius-Maximilians-Universität Würzburg — Würzburg
Arizona
- University Of Arizona College Of Medicine — Tucson
California
- University of California, San Francisco: Helen Diller Family Comprehensive Cancer Center — San Francisco
Florida
- Sylvester Comprehensive Cancer Center/ UMHC — Miami
Nebraska
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha
New Jersey
- Atlantic Health System / Morristown Medical Center — Morristown
Virginia
- Inova Dwight and Martha Schar Cancer Institute — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2021-05-19 |
| Est. Completion | 2025-11-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04526899
The ClinicalTrials.gov registry entry for NCT04526899 describes a study currently listed as completed. 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 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Unresectable Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Cemiplimab 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: NCT04526899 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Arizona, California. 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 NCT04526899 about?
NCT04526899 is a clinical study titled "A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment". This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III o...
What is the current status of trial NCT04526899?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2021-05-19. Estimated completion is 2025-11-24.
What conditions does trial NCT04526899 study?
This clinical trial studies the following conditions: Unresectable Melanoma, Melanoma Stage IV, Melanoma Stage III. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04526899?
The interventions under investigation include: Cemiplimab (BIOLOGICAL), BNT111 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04526899?
This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04526899 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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