A study to investigate the clinical and immunological effects on field cancerization in patients treated with PD-1 inhibition for advanced or metastatic cutaneous squamous cell carcinoma

Phase 1

• Conditions: advanced or metastatic cutaneous squamous cell carcinoma; MedDRA version: 24.1Level: LLTClassification code 10085908Term: Cutaneous squamous cell carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-006372-17-DE
• Lead Sponsor: Muehlenkreiskliniken AoeR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-07
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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.
11. No concomitant use of other approved or investigational antitumor agents.
12. No other serious illnesses, which might impact the outcome of the patient or the uptake of the drug significantly.
13. Patient consents to participate in the translational research project.

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.
8. Known alcohol or drug abuse.
9. Legal incapacity or limited legal capacity.

Study & Design

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