Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell Carcinomas

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aim is to assess the immunological and clinical response in basal cell carcinoma (BCC) treated with ablative fractionated laser (AFL) as monotherapy and compare with BCC treated with combination-therapy of AFL and the anti-PD1-drug nivolumab and with nivolumab as monotherapy.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bispebjerg Hospital
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• Patients 18 years or older

• Clinical suspicion of BCC or histologically verified BCC at baseline and histologically verified BCC at visit 2, irrespective of histologic subtype with diameter ≥7 mm at baseline.

• Signed informed consent.

• Female subjects of childbearing potential* must be confirmed not pregnant by a negative pregnancy test prior to study treatment and must use a safe contraceptive method

Exclusion Criteria:

• Concomitant treatment with 5-FU or imiquimod

• Concomitant chemotherapeutic treatment

• Concomitant systemic immunotherapeutic treatment, including Prednisolone

• Pregnant or lactating women

• Allergies to anti-PD1

• Patients with a tendency to form keloids

• Other skin diseases or tattoos in the treatment area