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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
BioNTech SE
Study ID
NCT04526899
Phase
PHASE2
Status
Completed

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV
  • Unresectable Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT111 — BIOLOGICAL
    IV injection
  • Cemiplimab — BIOLOGICAL
    IV infusion

Study Details

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.

Key Dates

Start date
May 19, 2021
Status verified
Dec 2025
Primary completion
Jan 25, 2024
Completion
Nov 24, 2025

Study Design

Enrollment
184 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BNT111 + cemiplimab
  • Experimental: BNT111 monotherapy
  • Experimental: Cemiplimab monotherapy

Primary Outcome Measure

Arm 1: Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
University Of Arizona College Of MedicineTucsonArizona85724-
University of California, San Francisco: Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-3214-
Sylvester Comprehensive Cancer Center/ UMHCMiamiFlorida33136-
Oncology Hematology West P.C. dba Nebraska Cancer SpecialistsOmahaNebraska68310-
Atlantic Health System / Morristown Medical CenterMorristownNew Jersey07962-
Inova Dwight and Martha Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Tucson, AZ

By research site
University Of Arizona College Of Medicine· Tucson, AZUniversity of California, San Francisco: Helen Diller Family Comprehensive Cancer Center· San Francisco, CASylvester Comprehensive Cancer Center/ UMHC· Miami, FLOncology Hematology West P.C. dba Nebraska Cancer Specialists· Omaha, NEAtlantic Health System / Morristown Medical Center· Morristown, NJInova Dwight and Martha Schar Cancer Institute· Fairfax, VA

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