A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07808515
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Basal Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Administered per the protocol
  • Vidutolimod — DRUG
    Administered per the protocol
  • Fianlimab — DRUG
    Administered per the protocol

Study Details

This study will test an experimental Regeneron drug called cemiplimab ("study drug") given alone or in combination with other anti-cancer drugs ("combination treatment") to see if they can help treat laBCC. The study is looking at: * What side effects cemiplimab, alone or in a combination treatment, might cause * How well cemiplimab, alone or in a combination treatment, works * How cemiplimab, alone or in a combination treatment could affect the immune system, which can help researchers understand why cemiplimab, alone or in a combination treatment, works better in some participants than others

Key Dates

First listed
Sep 9, 2026
Start date
Oct 15, 2026
Status verified
Jul 2026
Primary completion
Nov 13, 2030
Completion
Nov 13, 2030

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Experimental: Arm B
  • Experimental: Arm C
  • Experimental: Subsequent Therapy Arm

Primary Outcome Measure

Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria [ Time Frame: Up to approximately 3 years ]

Central Contacts

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