CClinicalTrials.gg
Sign In
Not yet recruitingNCT07808515Updated Sep 9, 2026

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

A Phase 2 interventional study of Cemiplimab and Vidutolimod in Locally Advanced Basal Cell Carcinoma, sponsored by Regeneron Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Histologic confirmation of BCC by local board-certified pathologist, as described in the protocol
  2. 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
  3. The treating physician must document that the participant is not appropriate for curative-intent surgery or curative-intent radiation
  4. 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
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Subsequent Therapy Arm - specific inclusion criteria:

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

Key Exclusion Criteria:

  1. 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)
  2. History or current evidence of significant cardiovascular disease, as described in the protocol
  3. Exposure to any prior systemic therapy (eg, HHI or an immune checkpoint inhibitor) or locally injectable agent for laBCC, as described in the protocol
  4. 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:

1. 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

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
135 participants (estimated)

Study arms

  • Experimental
    Arm A

    Drug: Cemiplimab

  • Experimental
    Arm B

    Drug: Cemiplimab · Drug: Vidutolimod

  • Experimental
    Arm C

    Drug: Cemiplimab · Drug: Fianlimab

  • Experimental
    Subsequent Therapy Arm

    Drug: Cemiplimab · Drug: Vidutolimod · Drug: Fianlimab

Interventions

  • DrugCemiplimab

    Administered per the protocol

    Also known as: Libtayo®, REGN2810

  • DrugVidutolimod

    Administered per the protocol

    Also known as: CMP001

  • DrugFianlimab

    Administered per the protocol

    Also known as: REGN3767

05

What researchers measure

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 \[modified World Health Organization (WHO) criteria\].

    Time frame: Up to approximately 3 years

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07808515
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Nov 13, 2030 (estimated)
Completion
Nov 13, 2030 (estimated)
Last update
Sep 9, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Skin Neoplasms→

Other studies from this sponsor

Regeneron Pharmaceuticals

Start the discussion