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NCT Number: NCT07808515

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Histologic confirmation of BCC by local board-certified pathologist, as described in the protocol
  • At least one lesion that is measurable by study criteria, defined as ≥ 1cm in at least one dimension, as assessed by radiology and/or digital medical photography, as described in the protocol
  • The treating physician must document that the participant is not appropriate for curative-intent surgery or curative-intent radiation
  • The treating physician must document that the participant does not wish to receive a hedgehog pathway inhibitor (HHI) or is not a candidate for an HHI
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Subsequent Therapy Arm - specific inclusion criteria:

  • Documentation of histopathologic diagnosis of basal cell carcinoma - NOT necessary
  • Submission of tumor or blood for exploratory correlative research - NOT necessary

Key Exclusion Criteria:

  • Metastatic disease to lymph node(s) or distant site(s) (Note: involvement of lymph node due to direct invasion from overlying cutaneous BCC is still considered laBCC, and is not excluded)
  • History or current evidence of significant cardiovascular disease, as described in the protocol
  • Exposure to any prior systemic therapy (eg, HHI or an immune checkpoint inhibitor) or locally injectable agent for laBCC, as described in the protocol
  • Current participation OR past participation in another investigational trial in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical trial.

Subsequent Therapy Arm - specific exclusion criteria:

  • Receipt of any anti-cancer therapy (including HHIs, radiation, surgery, or other systemic therapy) for BCC, AFTER treatment on Arms A, B, or C.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

cemiplimab

Drug

Administered per the protocol

Other names: Libtayo®, REGN2810

Vidutolimod

Drug

Administered per the protocol

Other names: CMP001

Fianlimab

Drug

Administered per the protocol

Other names: REGN3767

Primary outcomes

  1. Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria

    Time frame: Up to approximately 3 years

    Composite Response Criteria integrates radiology findings [Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] and external lesion assessments from digital photography [modified World Health Organization (WHO) criteria].

Secondary outcomes

  1. Duration of Response (DOR) by BICR per Composite Response Criteria

    Time frame: Up to approximately 3 years

  2. Time to Response (TTR) by BICR per Composite Response Criteria

    Time frame: Up to approximately 3 years

  3. Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria

    Time frame: Up to approximately 3 years

  4. Progression-Free Survival (PFS) by BICR per Composite Response Criteria

    Time frame: Up to approximately 3 years

  5. Objective Response by investigator review per Composite Response Criteria

    Time frame: Up to approximately 3 years

  6. DOR by investigator review per Composite Response Criteria

    Time frame: Up to approximately 3 years

  7. TTR by investigator review per Composite Response Criteria

    Time frame: Up to approximately 3 years

  8. Complete Response (CR) by investigator review per Composite Response Criteria

    Time frame: Up to approximately 3 years

  9. PFS by investigator review per Composite Response Criteria

    Time frame: Up to approximately 3 years

  10. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 3 years

  11. Severity of TEAEs

    Time frame: Up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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