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Merkel Cell Carcinoma, Stage IPhase 2NeoMatryxNCT07387198

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

A Phase 2 study testing Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles in people with Merkel Cell Carcinoma, Stage I and Merkel Cell Carcinoma, Stage II, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 14 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
14 sitesGermany
Study dates
29 May 2026to 31 Jul 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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:
  • Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection).
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  • Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent.
  • 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.
  • 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 p 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].
  • 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
  • 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 β-HCG pregnancy test result within 7 days prior to initiation of study treatment.
  • 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.
  • 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
  • Patient is legally incapacitated or has limited legal capacity

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ralf Gutzmer, Prof. Dr. med. contact

Ralf.Gutzmer@Muehlenkreiskliniken.de

Michelle Tez contact

tez.michelle@ikf-khnw.de

14 sites in 1 country

Germany14 sites, 14 recruiting

  • Klinikum Bielefeld

    Bielefeld, North Rhine-Westphalia, 33647

    Selma Ugurel, Prof. Dr.

    Recruiting

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

    Cindy Franklin, Prof. Dr.

    Not yet recruiting

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, 99089

    Rudolph Herbst, Prof. Dr.

    Recruiting

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

    Dirk Schadendorf, Prof. Dr.

    Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

    Bastian Schilling, Prof. Dr.

    Not yet recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

    Christoffer Gebhardt, Prof. Dr.

    Recruiting

  • Nationales Centrum für Tumorerkrankungen

    Heidelberg, Baden-Wurttemberg, 69120

    Jessica Hassel, Prof. Dr.

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

    Jan Christoph Simon, Prof. Dr.

    Not yet recruiting

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131

    Stefan Grabbe, Prof. Dr.

    Recruiting

  • Universitätsklinikum Mannheim

    Mannheim, Baden-Wurttemberg, 68161

    Jochen Utikal, Prof. Dr.

    Recruiting

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia, 32429

    Ralf Gutzmer, Prof. Dr.

    Not yet recruiting

  • Universitätsklinikum Regensburg

    Regensburg, Bavaria, 93053

    Sebastian Haferkamp, Prof. Dr.

    Not yet recruiting

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

    Ulrike Leiter-Stöppke, Prof. Dr.

    Recruiting

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

    Anja Gieserich, Dr.

    Recruiting

Other trials in Germany

About this study

Official title: Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab - A Randomized, Double-blind, Placebo-controlled, Non-comparative Phase II Study

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.

Being tested
Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles, Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.
Keywords
merkel cell carcinoma, sentinel lymph node, PD-1 antibody, skin cancer, Cemiplimab, MCC
Medical subject headings
Carcinoma, Merkel Cell, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called LIBTAYO

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

  • 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.

Study groups in NCT07387198
Study groupRoleWhat they receive
Arm A (Cemiplimab)Experimental2 cycles of Cemiplimab (350 mg, i.v., Q3W) followed by sentinel lymph node biopsy
Receives: Drug: Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles
Arm B (placebo)Placebo comparator2 cycles of placebo followed by sentinel lymph node biopsy
Receives: Drug: Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nodal micrometastases-free rate

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

    Measured: up to 36 months

Secondary outcomes (6)

  1. Recurrence-free survival

    time from randomization until date of the first of the following events: MCC progression, MCC recurrence, and MCC-related death

    Measured: up to 66 months

  2. Overall survival

    time from randomization until date of death from any cause

    Measured: up to 66 months

  3. Disease specific survival

    time from randomization until date of MCC-related death

    Measured: up to 66 months

  4. Quality of life using FCRI-SF questionnaire

    Quality of life determined using the FCRI-SF questionnaire

    Measured: up to 66 months

  5. Safety (AEs and SAEs)

    incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5

    Measured: up to 66 months

  6. Quality of life using the mFACT-M questionnaire

    Quality of life determined using the mFACT-M questionnaire

    Measured: up to 66 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start29 May 2026
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07387198
Sponsor's protocol ID
NeoMatryx
Acronym
NeoMatryx
Status last verified
Jun 2026
First submitted
28 Jan 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles in people with Merkel Cell Carcinoma, Stage I and Merkel Cell Carcinoma, Stage II, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 14 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ralf Gutzmer, Prof. Dr. med. (Ralf.Gutzmer@Muehlenkreiskliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nodal micrometastases-free rate (time frame: up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07387198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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