NCT07808515Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 13 Nov 2026
- Primary completion date
- 13 Nov 2030
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Melanoma
- NCT number
- NCT07808515
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 135
- From 13 Nov 2026 to the primary completion date, 13 Nov 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.