Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab (NCT07387198) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab
Germany135 participantsStarted 2026-06
Plain-language summary
The study is a randomized, double blind, placebo-controlled, non-comparative phase II trial that investigates the efficacy of neoadjuvant anti-PD-1 antibody Cemiplimab treatment in patients with clinical stage I or II Merkel cell carcinoma who have have undergone primary tumour excision and are pending sentinel lymph node biopsy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient has signed informed written consent.
✓. Patients is 18 years and older at time of signing of written informed consent
✓. Patient has diagnosis of Merkel cell carcinoma in clinical stage II, or in stage I with minimum diameter of 1 cm, with primary tumor already removed and a planned sentinel lymph nodes biopsy still pending.
✓. Patient has ECOG performance status 0-2.
✓. Patients has adequate laboratory parameters particularly for the blood count, renal and liver function parameters.
✓. Absolute number of neutrophils ≥ 1.5 x 109/L
✓. Platelets ≥ 75 x 109/L
✓. Hemoglobin ≥ 9 g/dL
Exclusion criteria
✕. Patient has prior sentinel lymph node removal for the current MCC.
✕. 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)
✕. Patient has active or a history of hematological neoplasms including chronic lymphocytic leukemia (CLL), irrespective if these require treatment or not.
✕. Patient had prior organ transplantation including allogenic stem-cell transplantation.
What they're measuring
1
Nodal micrometastases-free rate
Timeframe: up to 36 months
Trial details
NCT IDNCT07387198
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
. Patient receives immunosuppressive concomitant medication, EXCEPT for the following:
✕. 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.
✕. Patient has active autoimmune or inflammatory disorders.
✕. Patient has history of interstitial lung disease.