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
Public ClinicalTrials.gov record NCT04526899. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
Study identification
- NCT ID
- NCT04526899
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 184 participants
Conditions and interventions
Interventions
- BNT111 Biological
- Cemiplimab Biological
Biological
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
- May 18, 2021
- Primary completion
- Jan 24, 2024
- Completion
- Nov 23, 2025
- Last update posted
- Jan 7, 2026
2021 – 2025
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of Arizona College Of Medicine | Tucson | Arizona | 85724 | — |
| University of California, San Francisco: Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158-3214 | — |
| Sylvester Comprehensive Cancer Center/ UMHC | Miami | Florida | 33136 | — |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68310 | — |
| Atlantic Health System / Morristown Medical Center | Morristown | New Jersey | 07962 | — |
| Inova Dwight and Martha Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
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 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04526899, 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 Jan 7, 2026 · Synced May 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04526899 live on ClinicalTrials.gov.