EUCTR2019-003310-14-DK
Active, not recruiting
Phase 1
aser immunotherapy with and without topical anti-PD1 in basal cell carcinomas - Laser immunotherapy and topical anti-PD1
Department of Dermatology, Bispebjerg Hospital0 sites20 target enrollmentNovember 19, 2019
DrugsOpdivo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Basal cell carcinoma in 24-30 patients
- Sponsor
- Department of Dermatology, Bispebjerg Hospital
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients 18 years or older
- •Histologically verified BCC, 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •Concomitant treatment with 5\-FU or imiquimod
- •Concomitant chemotherapeutic treatment
- •Concomitant systemic immunotherapeutic treatment
- •Pregnant or lactating women
- •Allergies to anti\-PD1
- •Patients with a tendency to form keloids
- •Other skin diseases or tattoos in the treatment area.
Outcomes
Primary Outcomes
Not specified
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