advanced or metastatic cutaneous squamous cell carcinoma MedDRA version: 24.1 Level: LLT Classification code 10085908 Term: Cutaneous squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: LIBTAYO®
Product Name: Cemiplimab
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Cemiplimab
CAS Number: 1801342-60-8
Concentration unit: mg mi
Sponsors
Muehlenkreiskliniken AoeR
Eligibility
Sex/Gender
All
Inclusion 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. 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
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. Vaccination with any live vaccine (e.g. intranasal flu vaccine) within 4 weeks before the first dose of PD-1 inhibitor or planned vaccination with live vaccine during the trial 7. Any other systemic anti-tumor therapy in the last 4 weeks. 8. Pregnancy or lactation period. 9. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent. 10. Known alcohol or drug abuse. 11. Legal incapacity or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to investigate effects of Cemiplimab treatment on cSCC precursors (actinic keratoses (AK)) in patients who receive Cemiplimab as SoC for advanced cutaneous squamous cell carcinoma (cSCC). ;Secondary Objective: The secondary objective is to evaluate efficacy of Cemiplimab treatment on cSCC. The translational objective is the characterization of the tumor immunology and biology on response to Cemiplimab.;Primary end point(s): Clinical assessment of the severity of actinic keratoses during PD-1 inhibitior therapy as measure for efficacy.;Timepoint(s) of evaluation of this end point: week 3, 6, 12, 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints • Overall response rate defined as percentage of patients with CR and PR Translational Endpoints • Induction or boost of intralesional immune responses (as measured by immunohistology, mRNA expression and T-cell receptor repertoire usage analyses; variables will be determined at baseline and under therapy. • Analyses of predictive markers for AK response • Analysis of predictive markers for cSCC response ;Timepoint(s) of evaluation of this end point: • Overall response rate at 12 weeks and 24 weeks of cSCC • Translational Endpoints at week 3, 6, 12, 24 | — |
Countries
Germany
Contacts
Public ContactSkin Cancer Center Minden
Muehlenkreiskliniken AoeR
Outcome results
None listed