Cemiplimab Plus Imiquimod and Laser Therapy As Neoadjuvant Treatment In Cutaneous Basal Cell Carcinoma

Sponsor
Instituto Oncológico Dr Rosell
Study ID
NCT07251413
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cutaneous Basal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cemiplimab — DRUG
    cemiplimab 350 mg every 3 weeks for a total of 4 neoadjuvant cycles (12 weeks).
  • Topical imiquimod — DRUG
    Topical imiquimod 5% cream self-applied once daily 5 days per week (plus low-intensity laser therapy at 1- or 3-week interval),

Study Details

Basal cutaneous cell carcinoma (BCC) is the most common skin cancer. Early-stage disease is managed with surgery or radiation that cure more than 95% of patients. Surgical excision is the treatment of choice and by far the most convenient and effective means of achieving cure of any invasive BCC, Surgery is rarely contra-indicated even in old, debilitated patients, but in locally advanced tumors surgery has the potential of having functional and cosmetic consequences, due to a big tumor size or difficult locations and it is not uncommon tumors that are borderline for the indication of curative surgery. Patients with high-risk disease who have large primary lesions are usually not amenable to a definitive cure with local intervention and may experience significant morbidity, disfigurement, or functional deficits. In some patients, the tumors recur and progress locally being radiotherapy and Hedgehog inhibition therapy available options. Recently, cemiplimab was the first immunotherapy approved by the FDA and EMEA for locally advanced BCC after Hedgehog pathway inhibition The imiquimod (1-(2-methylpropyl)-1-H-imidazole \[4,5-c\] quinolone-amine) is a synthetic compound capable of activating the cells of the immune system, helping to control viruses, tumors, and intracellular parasites The combination of imiquimod plus anti PD-1 antibody could be synergistic. The main hypoteis is that combining cemiplimab, an immune checkpoint inhibitor targeting PD-1, and local treatment with the Toll-like receptor 7 (TLR7) agonist imiquimod may increase immune response against tumor and result in an increase in the rate of definitive cure y in patients with basal cell carcinoma (BCC) who have a high risk of recurrence after surgery alone or a high risk of morbidity, disfigurement, or functional deficits: to increase the rate of definitive cure. The CEMIQUID study main aims to evaluate: 1. The safety and toxicity of the combination of intravenous cemiplimab plus topical imiquimod (plus fractional laser therapy) as neoadjuvant treatment in patients with high risk and potentially resectable BCC. 2. The antitumoral activity in terms of 3-years rate of relapse-free survival (RFS) according to RECIST 1.1 of intravenous cemiplimab as single therapy or in combination with topical imiquimod plus fractional laser therapy as neoadjuvant treatment in patients with high risk and potentially resectable BCC. Patients with high risk, potentially resectable basal cell carcinoma (BCC), enrolled in the Phase Ib part of the study will receive treatment with intravenous (iv) cemiplimab plus topical imiquimod plus fractional laser therapy as neoadjuvant treatment. Patients enrolled in the Phase II part will be randomized to receive neoadjuvant cemiplimab as a single agent or the Phase Ib combination with imiquimod and fractional laser therapy

Key Dates

Start date
Oct 22, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1: cemiplimab neoadjuvant treatment
    Patients will be treated with single agent intravenous cemiplimab 350 mg every 3 weeks for a total of 4 neoadjuvant cycles (12 weeks).
  • Experimental: Cohort 2: cemiplimab plus topical imiquimod (plus fractional laser therapy) as neoadjuvant
    Patients will be treated with intravenous cemiplimab 350 mg every 3 weeks in combination with topical imiquimod 5% cream self-applied once daily 5 days per week (plus low-intensity laser therapy at 1- or 3-week interval), for a total of 4 neoadjuvant cycles (12 weeks).

Primary Outcome Measure

Incidence adverse events (AE) and treatment-related AEs (TRAEs) assessed by NCI CTCAE v5.0 [ Time Frame: During DLT evaluation period, the first 3 weeks of treatment for each patient ]

Central Contacts