Locally Advanced Basal Cell CarcinomaPhase 2NCT07808515
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
A Phase 2 study testing Cemiplimab, Vidutolimod and Fianlimab in people with Locally Advanced Basal Cell Carcinoma, run by Regeneron Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Basal Cell Carcinoma
- What is being tested?
- Cemiplimab, Vidutolimod and Fianlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2026to 13 Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm
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
- Being tested
- Cemiplimab, Vidutolimod, Fianlimab
- 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
- Medical subject headings
- Skin Neoplasms, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called Libtayo®, REGN2810
Administered per the protocol
VidutolimodDrug
Also called CMP001
Administered per the protocol
FianlimabDrug
Also called REGN3767
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Cemiplimab |
| Arm B | Experimental | Not described Receives: Drug: Cemiplimab; Drug: Vidutolimod |
| Arm C | Experimental | Not described Receives: Drug: Cemiplimab; Drug: Fianlimab |
| Subsequent Therapy Arm | Experimental | Not described Receives: Drug: Cemiplimab; Drug: Vidutolimod; Drug: Fianlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Up to approximately 3 years
Secondary outcomes (11)
Duration of Response (DOR) by BICR per Composite Response Criteria
Measured: Up to approximately 3 years
Time to Response (TTR) by BICR per Composite Response Criteria
Measured: Up to approximately 3 years
Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria
Measured: Up to approximately 3 years
Progression-Free Survival (PFS) by BICR per Composite Response Criteria
Measured: Up to approximately 3 years
Objective Response by investigator review per Composite Response Criteria
Measured: Up to approximately 3 years
DOR by investigator review per Composite Response Criteria
Measured: Up to approximately 3 years
TTR by investigator review per Composite Response Criteria
Measured: Up to approximately 3 years
Complete Response (CR) by investigator review per Composite Response Criteria
Measured: Up to approximately 3 years
PFS by investigator review per Composite Response Criteria
Measured: Up to approximately 3 years
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to approximately 3 years
Severity of TEAEs
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start13 Nov 2026 (estimated)
- Primary completion13 Nov 2030 (estimated)
- Study completion13 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808515
- Sponsor's protocol ID
- CMP001-ONC-2607
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm
- ClinicalTrials.gov ID
- NCT07808515
- Acronym / sponsor ID
- CMP001-ONC-2607
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 13 Nov 2030 (estimated)
- Study completion
- 13 Nov 2030 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: Libtayo®, REGN2810Administered per the protocol | Drug | Arm A, Arm B, Arm C, Subsequent Therapy Arm |
| VidutolimodAlso: CMP001Administered per the protocol | Drug | Arm B, Subsequent Therapy Arm |
| FianlimabAlso: REGN3767Administered per the protocol | Drug | Arm C, Subsequent Therapy Arm |
Primary outcome
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].
11 secondary outcomes
Duration of Response (DOR) by BICR per Composite Response Criteria
Time frame: Up to approximately 3 years
Time to Response (TTR) by BICR per Composite Response Criteria
Time frame: Up to approximately 3 years
Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria
Time frame: Up to approximately 3 years
Progression-Free Survival (PFS) by BICR per Composite Response Criteria
Time frame: Up to approximately 3 years
Objective Response by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
DOR by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
TTR by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
Complete Response (CR) by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
PFS by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 years
Severity of TEAEs
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab, Vidutolimod and Fianlimab in people with Locally Advanced Basal Cell Carcinoma, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.