Evaluation of immunological effects of the hedgehog inhibitors on basal cell carcinoma - An open label, prospective, observational biomarker study of the DeCOG.

Phase 1

• Conditions: Basal cell carcinoma; MedDRA version: 21.1Level: LLTClassification code 10064679Term: Basal cell carcinoma of skin in situSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-001309-22-DE
• Lead Sponsor: IQVIA Commercial GmbH & Co. OHG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-15
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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 < 2x upper limit of normal (ULN) or glomerular filtration rate > 30mL/min,
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5x ULN, bilirubin < 3x ULN.
10. Adequate contraception according to Pregnancy Prevention Program of the respective hedgehog inhibitor.
11. No concomitant use of other approved or investigational antitumor agents.
12. No other serious illnesses, in particular hematological neoplasia, which might impact the outcome of the patient or the uptake of the drug significantly.
13. Consent to participation in the the prospective skin cancer patients’ registry of Arbeitsgemeinschaft Dermatologische Onkologie (ADOREG) is mandatory for study participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified