basal cell carcinoma MedDRA version: 20.0 Level: LLT Classification code 10007286 Term: Carcinoma basal cell System Organ Class: 100000004864
Conditions
Interventions
Product Name: PD-L1 (Long1)
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: PD-L1 9-28
CAS Number: 190396-06-6
Current Sponsor code: PDL1 Long1
Other descr
Sponsors
Herlev and Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 At least 1 histological verified superficial or nodular basal cell carcinoma on the body or limbs of bigger than 14 mm in the longest diameter Willing to provide three 3 mm biopsies from the lesion/lesions Not previously treated with a hedgehog pathway inhibitor or retinoids ECOG performance score 0-1 For women: Agreement to use contraceptive methods with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: The patient has a history of life-threatening or severe immune related adverse events on treatment with another immunotherapy and is considered to be at risk of not recovering The patient has a history of severe clinical autoimmune disease The patient has a history of pneumonitis, organ transplant, human immunodeficiency virus positive, active hepatitis B or hepatitis C The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders) The patient is pregnant or breastfeeding The patient is unable to voluntarily agree to participate by signed informed consent or assent The patient has an active infection requiring systemic therapy The patient has received a live virus vaccine within 30 days of planned start of therapy Known side effects to Montanide ISA-51 Significant medical disorder according to investigator; e.g. severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus Concurrent treatment with other experimental drugs Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc. Severe allergy or anaphylactic reactions earlier in life.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the phase 1 study is to investigate overall response rate and immunogenicity after vaccination with PD-L1 in patients with basal cell carcinoma ;Secondary Objective: Assess the immunologic response to vaccination with PD-L1 peptide i perifial blood and biopsies before, during and after vaccination ;Primary end point(s): Disease control rate (DCR) defined as complete response (CR), partial response (PR), or stable disease (SD) of target lesion after 6 treatments with IO103. Rate of patients with CR, PR and SD. Objective and relative (%) reduction of the largest diameter of target lesion after 6 treatments with IO103. ;Timepoint(s) of evaluation of this end point: Baseline, then after second and sixth vaccination and during follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immune responses in biopsies from basal cell carcinomas (BCC) after treatment with IO103. Immune responses in skin delayed type hypersensitivity (DTH) Incidence of treatment emergent adverse events safety and tolerability) ;Timepoint(s) of evaluation of this end point: Blood samples (around 110mL per sample) will be taken at baseline (immediately before the 1st vaccination) and immediately before the 6th vaccination for isolation of PBMC and serum. A tumor biopsy will be obtained at baseline (screening) and after 2 and 6 vaccinations. | — |
Countries
Denmark
Contacts
Public ContactDept of Dermatology and Allergy
Herlev and Gentofte Hospital
Outcome results
None listed