Immunotherapy Clinical Trial
Official title:
Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell
Verified date | September 2020 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | November 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Dermatology | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | immunological response of AFL and nivolumab as monotherapy and AFL+Nivolumab in BCC | IHC as CD8/CD3 ratio CD4+Foxp3+/CD4 ratio |
1 week | |
Primary | investigate the clinical response of AFL and Nivolumab as monotherapy and AFL+Nivolumab in BCC | evaluated by tumor reduction measured in mm and documented by clinical photos | 12 weeks | |
Secondary | Tolerability of AFL, intratumoral nivolumab and AFL+Nivolumab | evaluated as local skin reactions 1 week and 12 weeks after exposure | 12 weeks | |
Secondary | Detection of intra-tumoral Nivolumab | evaluated by ELISA with anti-anti-PD1 | 1 week | |
Secondary | Analysis and quantification of PD-L1 expression (tumor cells and TILs) | evaluated by IHC | 2 weeks |
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