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

NCT07808515 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: CMP001-ONC-2607
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Locally Advanced Basal Cell Carcinoma

Keywords

BCC; laBCC; Skin Cancer; Non-melanoma skin cancer; Surgically unresectable; Unsuitable for radiotherapy; Inoperable Basal Cell Carcinoma; Recurrent Basal Cell Carcinoma; Cutaneous Basal Cell Carcinoma; Keratinocyte Carcinoma; High-Risk Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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

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

  Up to approximately 3 years

Secondary Outcomes (11)

• Duration of Response (DOR) by BICR per Composite Response Criteria

  Up to approximately 3 years

• Time to Response (TTR) by BICR per Composite Response Criteria

  Up to approximately 3 years

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

  Up to approximately 3 years

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

  Up to approximately 3 years

• Objective Response by investigator review per Composite Response Criteria

  Up to approximately 3 years

Study Arms (4)

Arm A

EXPERIMENTAL

Drug: Cemiplimab

Arm B

EXPERIMENTAL

Drug: Cemiplimab; Drug: Vidutolimod

Arm C

EXPERIMENTAL

Drug: Cemiplimab; Drug: Fianlimab

Subsequent Therapy Arm

EXPERIMENTAL

Drug: Cemiplimab; Drug: Vidutolimod; Drug: Fianlimab

Interventions

Vidutolimod DRUG

Administered per the protocol

Also known as: CMP001

Arm B; Subsequent Therapy Arm

Fianlimab DRUG

Administered per the protocol

Also known as: REGN3767

Arm C; Subsequent Therapy Arm

Cemiplimab DRUG

Administered per the protocol

Also known as: Libtayo®, REGN2810

Arm A; Arm B; Arm C; Subsequent Therapy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Basal Cell

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 9, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): November 13, 2030
• Study Completion (Estimated): November 13, 2030
• Last Updated: September 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf