Can pairing immunotherapy drugs shrink Hard-to-Treat skin cancers?
NCT ID NCT07808515
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing the drug cemiplimab, given alone or with other anti-cancer drugs, in people with locally advanced basal cell carcinoma that cannot be treated with surgery or radiation. The trial compares how well the combinations work against cemiplimab by itself and tracks side effects. It also studies how the treatments affect the immune system to understand why some people respond better than others.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cemiplimab, alone or combined with vidutolimod or fianlimab
- What this could lead to
- If the combinations work better than cemiplimab alone, doctors could have stronger options for basal cell carcinoma that cannot be removed with surgery or radiation.
- What could go wrong
- This is a Phase 2 trial, so researchers are still learning whether the combinations help and how safe they are. Immune-based cancer drugs can cause serious side effects, and the combinations may not outperform cemiplimab by itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 135 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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