Basal cell carcinoma MedDRA version: 21.1 Level: LLT Classification code 10064679 Term: Basal cell carcinoma of skin in situ System Organ Class: 100000004864
Conditions
Sponsors
IQVIA Commercial GmbH & Co. OHG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of advanced BCC (surgery or radiotherapy not possible, contra¬indicated or refused by patient). 2. Decision to perform medical treatment with a hedgehog inhibitor with either sonidegib or vismodegib as SoC by an interdisciplinary tumor board. Patients who already received a previous hedgehog inhibitor treatment which was discontinued at least 90 days before start of actual hedgehog inhibitor treatment may also be enrolled. 3. Possibility and consent to perform one biopsy of at least 0.5ccm (pea-sized) before initiation of treatment and an additional biopsy 14 days after start of treatment, respectively. 4. Age = 18 years. 5. Ability to understand and sign a written informed consent. 6. Expected survival of at least 6 months. 7. ECOG performance status 0, 1 or 2. 8. Rest period of at least 2 weeks to prior major surgery, radiotherapy or any previous systemic or local treatment. 9. Adequate laboratory parameters including blood count, renal and liver function parameters. - hemoglobin > 9g/L, thrombocytes > 75.000/µL, leukocytes > 2000/µL, - creatinine 30mL/min, - alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Current use of immunosuppressive medication, EXCEPT for the following: - Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection), - Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent, - Steroids as premedication for hypersensitivity reactions (e.g., Computed tomography [CT] scan premedication). 2. Active infection requiring systemic therapy. 3. Known history of testing positive for Human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 4. Pregnancy or lactation period. 5. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent. 6. Known alcohol or drug abuse. 7. Legal incapacity or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: Immunologic assessment of advanced Basal Cell Carcinoma before and during hedgehog inhibitor therapy as measured by single cell ribonucleicacid-sequencing (scRNA-seq) and T-cell receptor sequencing (scTCR-seq) in 10X Genomics technology, bulk transcriptomics by EDGEseq, and multiplexed immunofluoresence. ;Secondary Objective: Secondary objective: Efficacy of hedgehog inhibition.;Primary end point(s): Quantification as well as differentiation and activation status of tumor-infiltrating T cells.;Timepoint(s) of evaluation of this end point: Timepoints of evaluation: day 14, 6 and 12 weeks after start of hedgehog inhibitor therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumor response at month three after start of hedgehog-inhibitor therapy (end of study).;Timepoint(s) of evaluation of this end point: Month three after start of hedgehog-inhibitor therapy (end of study). | — |
Countries
Germany
Contacts
Public ContactSponsor
IQVIA Commercial GmbH & Co. OHG
Outcome results
None listed