Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery

Part of paid clinical trials in Miami, Florida.

Sponsor
Thomas Jefferson University
Study ID
NCT05929664
Phase
PHASE2
Status
Suspended

Conditions

Eligibility Criteria

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

Interventions

  • Cemiplimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Fianlimab — BIOLOGICAL
    Fianlimab (REGN3767) administered intravenously in combination with Cemiplimab.

Study Details

A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at least 2 and up to 6 infusions of immunotherapy prior to surgical resection. If patients have progression on neoadjuvant treatment, they may switch to standard of care surgical resection or hedgehog inhibitors prior to surgery. The primary endpoints are objective response rate and disease control rate. Safety and surgical benefit rate (de-escalation of surgery) with preservation of key anatomic structures are secondary endpoints. Correlative endpoints include analysis of pre and post treatment primary tumor and blood samples compared for histology, tumor genetics and immune cell composition.

Key Dates

Start date
Jul 5, 2023
Status verified
May 2026
Primary completion
Jul 5, 2031
Completion
Jul 5, 2031

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Cemiplimab
    Patients will undergo 2 infusions of Cemiplimab (Cemi), 350 mg every 3 weeks. Patients undergo CT or MRI scans and collection of blood samples throughout the trial. Patients also undergo biopsies during screening and on study. The recommended dose of Cemiplimab is 350 mg as an intravenous infusion over 30 minutes every 3 weeks (constituting one cycle). Dosing will occur in this manner for a single dose of 350mg Cemiplimab every 3 weeks constituting 1 cycle of therapy. Patients will undergo at least 2 cycles of Cemiplimab and at most, 4 additional cycles dependent upon treatment response.
  • Experimental: Cohort 2: Fianlimab + Cemiplimab
    Patients will undergo infusions of Cemiplimab (C) and Fianlimab (F), 350 mg Cemiplimab + 1600 mg Fianlimab every 3 weeks. Fianlimab in combination with cemiplimab can be administered to patients in a sequential order through co-administration, or concurrently via a fixed-dose combination (FDC). When the FDC is used, the drug product containing co-formulated drugs in a vial is injected into the IV bag and delivered intravenously to the patient. FDC of fianlimab 1600 mg + cemiplimab 350 mg will be administered as a single infusion over 30 to 40 minutes every 3 weeks (constituting one cycle). Patients will undergo at least 2 cycles of the FDC and at most, 4 additional cycles dependent upon treatment response.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 6 months post surgery (up to Day 309 +/- 3 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Miami Health SystemMiamiFlorida33136-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Vanderbilt UniversityNashvilleTennessee37232-

Find similar trials in Miami, FL

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By research site
University of Miami Health System· Miami, FLThomas Jefferson University Hospital· Philadelphia, PAVanderbilt University· Nashville, TN

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