Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab

NCT07387198 | Not Yet Recruiting Phase 2

• 1 other identifier: NeoMatryx
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Merkel Cell Carcinoma, Stage I; Merkel Cell Carcinoma, Stage II; Neoadjuvant Immunotherapy

Keywords

merkel cell carcinoma; sentinel lymph node; PD-1 antibody; skin cancer; Cemiplimab; MCC

Outcome Measures

Primary Outcomes (1)

• Nodal micrometastases-free rate

  rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy

  up to 36 months

Secondary Outcomes (6)

• Recurrence-free survival

  up to 66 months

• Overall survival

  up to 66 months

• Disease specific survival

  up to 66 months

• Quality of life using FCRI-SF questionnaire

  up to 66 months

• Safety (AEs and SAEs)

  up to 66 months

Other Outcomes (1)

• Investigation of prognostic and predictive biomarkers to estimate the risk of lymph node metastases and signs of immune activation in the sentinel lymph nodes

  up to 66 months

Study Arms (2)

Arm A (Cemiplimab)

EXPERIMENTAL

2 cycles of Cemiplimab (350 mg, i.v., Q3W) followed by sentinel lymph node biopsy

Drug: Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles

Arm B (placebo)

PLACEBO COMPARATOR

2 cycles of placebo followed by sentinel lymph node biopsy

Drug: Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.

Interventions

Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles. DRUG

Patients will receive NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.

Arm B (placebo)

Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles DRUG

Patients will receive Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles

Also known as: LIBTAYO

Arm A (Cemiplimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• AST (SGOT) and ALT (SGPT) ≤ 3x ULN
• AP ≤ 2.5x ULN
• Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
• 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.
• Patient must be willing to allow translational work-up of tissue samples (PT, sentinel lymph node biopsy).

You may not qualify if:

• 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.
• 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).
• 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.
• Patient has active infection requiring systemic therapy.
• 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.

Sponsors & Collaborators

• Prof. Gutzmer, Skin Cancer Center Minden, Johannes-Wesling-Klinikum Minden, Germany: collaborator
• Prof. Becker, Translational Skin Cancer Research University Duisburg-Essen, Germany: collaborator
• Regeneron Pharmaceuticals: collaborator
• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead

Study Sites (14)

Nationales Centrum für Tumorerkrankungen

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Baden-Wurttemberg, 68161, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Klinikum Bielefeld

Bielefeld, North Rhine-Westphalia, 33647, Germany

Location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, 32429, Germany

Location

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Helios Klinikum Erfurt

Erfurt, Thuringia, 99089, Germany

Location

MeSH Terms

Conditions

Carcinoma, Merkel Cell; Skin Neoplasms

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Salah Al-Batran, Prof. Dr.

  Institut für Klinische Krebsforschung IKF GmbH

  STUDY DIRECTOR

• Ralf Gutzmer, Prof. Dr. med.

  Johannes Wesling Klinikum Minden

  PRINCIPAL INVESTIGATOR

• Juergen C. Becker, Prof. Dr. Dr.

  Translational Skin Cancer Research University Duisburg-Essen, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralf Gutzmer, Prof. Dr. med.

CONTACT

Ralf.Gutzmer@Muehlenkreiskliniken.de

Michelle Tez

CONTACT

tez.michelle@ikf-khnw.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): July 31, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (14)