CEMIPLIMAB for Merkel cell carcinoma

Inclusion criteria

• {"criterion_text":"- 1. Patient has signed informed written consent.\n- 2. Patients is 18 years and older at time of signing of written informed consent.\n- 3. Patient has diagnosis of Merkel cell carcinoma in clinical stage II, or in stage I with minimum diameter of 1 cm, with the primary tumor already removed and a planned sentinel lymph node biopsy still pending.\n- 4. Patient has ECOG performance status 0-2.\n- 5. Patients has adequate laboratory parameters particularly for the blood count, renal and liver function parameters. a. Absolute number of neutrophils ≥ 1.5 x 10⁹ /L b. Platelets ≥ 75 x 10⁹ /L c. Hemoglobin ≥ 9 g/dL d. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with Gilbert´s Disease and total bilirubin up to 3x ULN may be eligible after approval from trial’s medical expert) e. AST (SGOT) and ALT (SGPT) ≤ 3x ULN f. AP ≤ 2.5x ULN g. Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min\n- 6. Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of Cemiplimab. Male patients must refrain from donating sperm during this same period. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy.\n- 7. Patient must be willing to allow translational work-up of tissue samples (primary tumor, sentinel lymph node biopsy)."}

Exclusion criteria

• {"criterion_text":"- 1. Patient has prior sentinel lymph node removal for the current MCC.\n- 10. Patient has Active infection requiring systemic therapy, including uncontrolled HIV, HBV and HCV infection or diagnosis of immunodeficiency. NOTE: Patients are eligible if: • Patients have controlled HIV infection with CD4 counts is > 350 cells/µL and viral load is undetectable [HIV RNA PCR]. Patients with controlled HIV infection must be monitored per local standards during the trial. • Patients positive for HBV surface antigen have controlled HBV infection receiving anti-viral therapy and with undetectable serum viral load [HBV DNA PCR]. Patients with controlled infection must undergo periodic monitoring of HBV DNA and must remain on anti-viral therapy for at least 6 months after last dose of Cemiplimab • Patients positive for HCV antibody have controlled HCV infection with undetectable viral load [HCV RNA PCR]\n- 11. Patent received vaccination with any live vaccine (e.g., intranasal flu vaccine) within 4 weeks before the first dose of Cemiplimab or planned vaccination with live vaccine during the trial.\n- 12. Female patients, who are pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment.\n- 13. Patient has evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the study medications, puts the patient at higher risk for treatment- related complications or may affect the interpretation of study results.\n- 14. Patient has known substance abuse or other psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.\n- 15. Patient is legally incapacitated or has limited legal capacity.\n- 2. Patients received prior treatment with immunotherapy (such as PD-1/PD-L1 or CTL4) or any other systemic anti-tumor (MCC) therapy (incl. investigational therapies)\n- 3. Patient has active or a history of hematological neoplasms including chronic lymphocytic leukemia (CLL), irrespective if these require treatment or not.\n- 4. Patient had prior organ transplantation including allogenic stem-cell transplantation.\n- 5. Patient receives immunosuppressive concomitant medication, EXCEPT for the following: i. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra- articular injection). ii. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent. iii. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n- 6. Patient has known hypersensitivity to any component of the Cemiplimab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein.\n- 7. Patient has active autoimmune or inflammatory disorders\n- 8. Patient has history of interstitial lung disease\n- 9. Patient has active infection requiring systemic therapy."}

Primary endpoints

• {"endpoint_text":"- Nodal micrometastases-free rate defined as the rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy","definition_or_measurement_approach":"Defined as the rate of patients without nodal micrometastases after 2 cycles of treatment; assessment determined by sentinel lymph node biopsy."}

Secondary endpoints

• {"endpoint_text":"- Recurrence-free survival (RFS) defined as time from randomization until date of to the date of the first of the following events: i. MCC progression or ii. MCC recurrence or iii. MCC-related death (DSS)\n- Overall survival (OS), defined as time from randomization until date of death from any cause\n- Disease specific survival (DSS), defined as time from randomization until date of MCC-related death\n- Quality of life (QoL) using FACT-M questionnaire: (i) FCRI-SF questionnaire (ii) mFACT-M questionnaire\n- Descriptive comparison of neoadjuvant Cemiplimab with placebo treatment prior to sentinel lymph node biopsy regarding: nodal micrometastases-free rate, RFS, OS, DSS, QoL\n- Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5\n- Descriptive comparison of safety between neoadjuvant Cemiplimab and placebo treatment prior to sentinel lymph node biopsy\n- Correlation of identified biomarker with clinical outcome, i.e., nodal metastases-free rate, RFS, OS","definition_or_measurement_approach":"RFS: time from randomization to first event (MCC progression, recurrence, or MCC-related death). OS: time from randomization to death from any cause. DSS: time from randomization to MCC-related death. QoL assessed using FACT-M, FCRI-SF and mFACT-M questionnaires. Safety assessed by incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE v5. Biomarker correlations assessed versus clinical outcomes (nodal metastases-free rate, RFS, OS). Descriptive comparisons between neoadjuvant Cemiplimab and placebo for listed efficacy and safety endpoints."}

Germany

Earliest CTIS Part Ii Submission Date

28-10-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

132

Number Of Sites

14

Number Of Participants

135

Primary sponsor

Full Name

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Translational Skin Cancer Research - University Duisburg-Essen","duties_or_roles":"Central Pathological Evaluation","organisation_type":"Health care"}
• {"country":"Germany","full_name":"Medicoline Pharma Solutions KG","duties_or_roles":"","organisation_type":"Pharmaceutical company"}