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Triple therapy aims to cure High-Risk skin cancer without disfigurement

NCT ID NCT07251413

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining an immunotherapy drug (cemiplimab), a topical cream (imiquimod), and laser therapy before surgery can cure high-risk basal cell skin cancer. About 18 adults with large or difficult-to-treat tumors will receive the combination or immunotherapy alone. The goal is to increase the chance of a definitive cure and reduce the need for disfiguring surgery.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 18 people

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

Started

Oct 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent. 2. Histologically confirmed diagnosis of basal cell carcinoma (BCC), potentially resectable with curative intention. 1. The definition of resectability will be determined locally by the surgeon according to his/her criteria and local standard guidelines. The validated classification from University Hospital of Lille should be used for guidance in resectability assessment (Appendix 11). 2. Surgery would be recommended in routine clinical practice. 3. Patient should be considered as high risk, defined as: 1. at least 1 large lesion (≥ 2 cm in diameter in trunk/extremities or any size in Head, neck, hands, feet, pretibial, and anogenital) still resectable, but with increased risk for cosmetic disfigurement or functional defects by assessment of the enrolling physician. 2. Having basosquamous, infiltrative, sclerosing/morpheaform, micronodular, and BCC with carcinosarcomatous differentiation features in any portion of the tumor. 3. Patients with large (≥ 3 cm in diameter in areas of intermedium risk of recurrence such as forehead, cheek, chin, neck, scalp or ≥ 5 cm for lesions in trunk/extremities) recurrent basal cell carcinoma are also eligible. 4. Multicentric tumors that would require a cosmetic disfigurement or functional defects by assessment of the enrolling physician will be eligible. 4. At least one measurable lesion by RECIST v1.1 (Appendix 3). 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 6. Life expectancy of at least 24 weeks. 7. Pretreatment tumor tissue sample available. Note: If the biopsy is considered by the investigator to pose an unacceptable safety risk to the patient or would compromise tumor measurements, the biopsy requirement may be waived for an individual patient after notification of the medical monitor. For patients without on-study screening biopsy, an archival FFPE tissue sample (block or 25 unstained slides) should be provided. 8. Adequate normal organ and marrow function as defined below: 1. Absolute neutrophil count ≥ 1.5 x 109 cells/L 2. Platelets ≥ 75 x 109/L 3. Hemoglobin ≥ 8 g/dL 4. Aspartate and alanine aminotransferases (AST, ALT) ≤ 3 x upper limit of normal (ULN) and alkaline phosphatase \<2.5x ULN 5. Thyroid stimulating hormone (TSH) within normal limits, or Total triiodothyronine (T3) is within normal limits, or Free T3 and free thyroxine (T4) are within the normal limits 6. Total bilirubin ≤ 2 x ULN (except patients with documented Gilbert's syndrome; up to 3 x ULN) 7. Creatinine \< 2 mg/dl (or a glomerular filtration rate \> 60) 9. Female patients of childbearing potential (WOCBP) must provide a negative urine pregnancy test 72 hours prior to the first administration of study treatment, and must agree to: (I) use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%; refer to Appendix 6); (II) refrain from donating ovules; and (III) refrain from breastfeeding for the duration of the study treatment and for 180 days after the last dose of cemiplimab. \- A woman is considered of childbearing potential ( i.e. fertile) following menarche and until becoming postmenopausal unless permanently sterile. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply: 1. Amenorrheic for ≥1 year in the absence of chemotherapy and/or hormonal treatments 2. Luteinizing hormone (LH) and/or follicle stimulating hormone and/or estradiol levels in the postmenopausal range 3. Radiation induced oophorectomy with last menses \>1 year ago 4. Chemotherapy induced menopause with \>1 year interval since last menses 5. Surgical sterilization (bilateral oophorectomy or hysterectomy) 6. Women \<50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy) 7. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 10. Male participants of reproductive potential are eligible to participate if they agree to the following starting with the first dose of study treatment through at least 180 days (a spermatogenesis cycle) after the last dose of study treatment: 1. Refrain from donating sperm plus, either: 2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent, or 3. Must agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a WOCBP who is not currently pregnant. Exclusion Criteria: 1. Distant metastatic disease (M1), visceral and/or distant nodal. 2. Patients who have another malignancy that is progressing or requires active treatment, except: 1. Non-melanoma skin cancer that has undergone potentially curative therapy In situ cervical carcinoma 2. Any tumor that has been deemed to be effectively treated with definitive local control (with or without continued adjuvant hormonal therapy). 3. Patients who have received a previous systemic treatment for cancer within the last previous 3 months or 5 half-lives (whichever is latest), including immunotherapy, prior to initiation of dosing within this protocol. 4. History of, or significant evidence of risk for, severe chronic inflammatory or autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that has resolved, or psoriasis that does not require systemic treatment are permitted. 5. Patients who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization. Note: Patients should remain on antiviral therapy throughout trial treatment and follow. 6. Patients with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted. 7. Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 100 on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards. 8. Active tuberculosis. 9. Receipt of a live vaccine within 28 days of enrollment. 10. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation. 11. Recipient of a solid organ transplant (other than corneal transplants). 12. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. 13. Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment. Notes: Physiologic replacement doses are allowed even if they are \>10 mg of prednisone/day or equivalent. Inhaled or topical steroids at standard doses are allowed. Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication are eligible for the study. 14. Has participated in a study of an investigational agent or an investigational device within 4 weeks of enrollment. 15. Dementia or significantly altered mental status, or any social or economic conditions that would prohibit or interfere with the understanding or rendering of informed consent and compliance with the requirements of this protocol. 16. Female patients who are pregnant or breast-feeding.

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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 places running it

    4 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Hospital Clínic de Barcelona. Carrer de Villarroel, 170, L'Eixample

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital Miguel Servet de Zaragoza. P.º de Isabel la Católica, 1-3

    RECRUITING

    Zaragoza, Zaragoza, 5009, Spain

  • Hospital Ramón y Cajal. M-607, Km. 9, 100, Fuencarral-El Pardo,

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Dexeus - Grupo Quirónsalud. Carrer de Sabino Arana, 19 Ed, Distrito de Les Corts

    RECRUITING

    Barcelona, Barcelona, 08028, Spain

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