EUCTR2021-006372-17-DE
Active, not recruiting
Phase 1
Evaluation of clinical and immunological effects of PD-1 inhibition on actinic keratoses in patients with advanced or metastatic cutaneous squamous cell carcinoma in combination with a pronounced field cancerization – An open label, prospective, observational biomarker study of the DeCOG - Field Cancerization
Muehlenkreiskliniken AoeR0 sites20 target enrollmentDecember 7, 2021
Conditionsadvanced or metastatic cutaneous squamous cell carcinomaMedDRA version: 24.1Level: LLTClassification code 10085908Term: Cutaneous squamous cell carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsLIBTAYO®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- advanced or metastatic cutaneous squamous cell carcinoma
- Sponsor
- Muehlenkreiskliniken AoeR
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Centrally confirmed histological diagnosis of advanced cutaneous squamous cell carcinoma (cSCC): either locally advanced or metastatic, surgery or radiotherapy not possible, contraindicated or refused by patient.
- •2\. Coexistence of cSCC precursor lesions, i.e. field cancerization larger than 5x5cm and/or at least 6 separate actinic keratosies.
- •3\. Decision to perform medical treatment with PD\-1 inhibitor as Standard of Care.
- •4\. 18 years and older.
- •5\. Ability to understand and sign a written informed consent.
- •6\. Expected survival of at least 6 months.
- •7\. ECOG performance status: 0\-2\.
- •8\. Washout period of at least 2 weeks to prior major surgery, radiotherapy or any previous systemic or local treatment.
- •9\. Adequate laboratory parameters particularly for the blood count, renal and liver function parameters.
- •10\. In female patients: adequate contraception or no childbearing potential.
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., CT scan premedication).
- •2\. Prior organ transplantation including allogenic stem\-cell transplantation.
- •3\. Active infection requiring systemic therapy.
- •4\. Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
- •5\. Hematological neoplasms including chronic lymphocytic leukemia (CLL).
- •6\. Pregnancy or lactation period.
- •7\. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
Outcomes
Primary Outcomes
Not specified
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