Basal cell carcinoma in 24-30 patients
Conditions
Interventions
Trade Name: Opdivo
Product Name: Opdivo
Pharmaceutical Form: Solution for infusion
Sponsors
Department of Dermatology, Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives: • Tolerability of AFL+Nivolumab evaluated as local skin reactions • Detection of intra-tumoral Nivolumab evaluated by ELISA with anti-anti-PD1 • Analysis and quantification of PD-L1 expression (tumor cells and TILs) evaluated by IHC ;Primary end point(s): 1. the immunological response of AFL as monotherapy and AFL+Nivolumab in BCC evaluated by IHC 2. the clinical response of AFL as monotherapy and AFL+Nivolumab in BCC evaluated by tumor reduction measured in mm and documented by clinical photos;Main Objective: The study aim is to assess the immunological and clinical response in BCC treated with AFL or intratumoral nivolumab as monotherapy and compare with BCC treated with combination-therapy of AFL and the anti-PD1-drug Nivolumab (intratumoral). Primary objectives 1. To investigate the immunological response of AFL or intratumoral nivolumab as monotherapy and AFL+Nivolumab (intratumoral) in BCC 2. To investigate the clinical response of AFL or nivolumab (intratumoral) as monotherapy and AFL+Nivolumab in BCC ;Timepoint(s) of evaluation of this end point: 1. the immunological response of AFL as monotherapy and AFL+Nivolumab in BCC evaluated by IHC performed 1 week efter AFL+Nivolumab exposure 2. the clinical response of AFL as monotherapy and AFL+Nivolumab in BCC evaluated by tumor reduction measured in mm and documented by clinical photos evaluated 12 weeks after AFL+Nivolumab exposure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Tolerability of AFL+Nivolumab evaluated as local skin reactions 2. Detection of intra-tumoral Nivolumab evaluated by ELISA with anti-anti-PD1 3. Analysis and quantification of PD-L1 expression (tumor cells and TILs) evaluated by IHC ;Timepoint(s) of evaluation of this end point: 1. Tolerability of AFL+Nivolumab evaluated as local skin reactions 1 week and 12 weeks after exposure 2. Detection of intra-tumoral Nivolumab evaluated by ELISA with anti-anti-PD1 1 week after Nivolumab exposure 3. Analysis and quantification of PD-L1 expression (tumor cells and TILs) evaluated by IHC performed at baseline visit prior to AFL+Nivolumab exposure | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology
Bispebjerg Hospital
Outcome results
None listed