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Can pairing immunotherapy drugs shrink Hard-to-Treat skin cancers?

NCT ID NCT07808515

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.