NeoMatryx - Neoadjuvant Merkel cell carcinoma therapy (Tx) with the PD-1 inhibitor Cemiplimab – A randomized, double-blind, placebo-controlled, non-comparative Phase II study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 May 2026 → ongoing

Decision date (initial)

2026-01-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Regeneron Pharmaceuticals

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The primary objective is to evaluate the immediate efficacy of neoadjuvant anti-PD-1 antibody Cemiplimab treatment prior to sentinel lymph node biopsy in patients with clinical stage I or II Merkel cell carcinoma (MCC).

Secondary objectives 4

1. To characterize the sustained efficacy, i.e., improved RFS and DSS, of neoadjuvant Cemiplimab treatment prior to sentinel lymph node biopsy in patients with clinical stage I or II MCC
2. To evaluate safety and tolerability of neoadjuvant Cemiplimab treatment prior to sentinel lymph node biopsy in patients with clinical stage I or II MCC.
3. To compare descriptively neoadjuvant Cemiplimab with placebo treatment prior to sentinel lymph node biopsy in patients with clinical stage I or II MCC.
4. Investigation of prognostic and predictive biomarkers to estimate the risk of lymph node metastases and signs of immune activation in the sentinel lymph nodes.

Conditions and MedDRA coding

Merkel Cell Carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Patient has signed informed written consent.
2. 2. Patients is 18 years and older at time of signing of written informed consent.
3. 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.
4. 4. Patient has ECOG performance status 0-2.
5. 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
6. 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.
7. 7. Patient must be willing to allow translational work-up of tissue samples (primary tumor, sentinel lymph node biopsy).

Exclusion criteria 15

1. 1. Patient has prior sentinel lymph node removal for the current MCC.
2. 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)
3. 3. Patient has active or a history of hematological neoplasms including chronic lymphocytic leukemia (CLL), irrespective if these require treatment or not.
4. 4. Patient had prior organ transplantation including allogenic stem-cell transplantation.
5. 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).
6. 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.
7. 7. Patient has active autoimmune or inflammatory disorders
8. 8. Patient has history of interstitial lung disease
9. 9. Patient has active infection requiring systemic therapy.
10. 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]
11. 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.
12. 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.
13. 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.
14. 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.
15. 15. Patient is legally incapacitated or has limited legal capacity.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Nodal micrometastases-free rate defined as the rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy

Secondary endpoints 8

1. 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)
2. Overall survival (OS), defined as time from randomization until date of death from any cause
3. Disease specific survival (DSS), defined as time from randomization until date of MCC-related death
4. Quality of life (QoL) using FACT-M questionnaire: (i) FCRI-SF questionnaire (ii) mFACT-M questionnaire
5. Descriptive comparison of neoadjuvant Cemiplimab with placebo treatment prior to sentinel lymph node biopsy regarding: nodal micrometastases-free rate, RFS, OS, DSS, QoL
6. Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5
7. Descriptive comparison of safety between neoadjuvant Cemiplimab and placebo treatment prior to sentinel lymph node biopsy
8. Correlation of identified biomarker with clinical outcome, i.e., nodal metastases-free rate, RFS, OS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Sponsor organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Address

Steinbacher Hohl 2-26, Praunheim Praunheim

City

Frankfurt Am Main

Postcode

60488

Country

Germany

Scientific contact point

Organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Contact name

Clinical Trial Project Manager

Public contact point

Organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Contact name

Clinical Trial Project Manager

Third parties 2

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications