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 2026-10-30.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
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:
389 studies on the registry are indexed under Carcinoma, Basal Cell; 69 are open to participants now.
This study's planned enrollment of 135 is above the median of 50 across 272 interventional studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Compared within Carcinoma, Basal Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Skin Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Subsequent Therapy Arm - specific inclusion criteria:
Key Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cemiplimab
Drug: Cemiplimab · Drug: Vidutolimod
Drug: Cemiplimab · Drug: Fianlimab
Drug: Cemiplimab · Drug: Vidutolimod · Drug: Fianlimab
Administered per the protocol
Also known as: Libtayo®, REGN2810
Administered per the protocol
Also known as: CMP001
Administered per the protocol
Also known as: REGN3767
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
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
No study locations are listed for this record.
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2030, 48 months later.
Of 43 phase 2 interventional studies under Carcinoma, Basal Cell, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 67. This study's planned 48 months is close to that.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cemiplimab