Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma

NCT04975152 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MCC-20794
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to determine if Cemiplimab-rwlc (called Cemiplimab in this document) given prior to tumor resection surgery is safe and effective in treating (1) Merkel Cell Carcinoma or (2) Cutaneous Squamous Cell Carcinoma (CSCC).

Conditions

Merkel Cell Carcinoma; Cutaneous Squamous Cell Carcinoma

Keywords

Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events Related to Study Treatment

  Number of participants with adverse events after receiving at least one dose of cemiplimab

  Beginning of treatment to end of follow up, up to 3 years

Secondary Outcomes (2)

• Relapse Free Survival

  Up to 3 years

• Overall Survival

  Up to 3 years

Study Arms (1)

Neoadjuvant Cemiplimab Treatment

EXPERIMENTAL

Participants will receive cemiplimab 350 mg IV at least 3 weeks prior to surgical resection. After surgery they will continue to receive 350 mg cemiplimab every 3 weeks for up to 8 additional doses.

Drug: Cemiplimab-Rwlc

Interventions

Cemiplimab-Rwlc DRUG

Flat dose of cemiplimab-rwlc 350 mg IV every 3 weeks, up to 9 cycles.

Also known as: Libtayo

Neoadjuvant Cemiplimab Treatment

Eligibility Criteria

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

You may qualify if:

• Histologically proven diagnosis of Merkel cell carcinoma (MCC).
• Clinical stage I-II MCC (AJCC 8th edition) either newly diagnosed or previously diagnosed with recent disease recurrence. This includes patients with a previous diagnosis of clinical Stage I-II who present with local or regional disease recurrence.
• Patients must be considered candidates for wide local surgical excision and may be candidates for sentinel lymph node biopsy. If sentinel biopsy is determined to not be clinically indicated then it would not be required to be completed and only the tumor excision would be required.
• Patients with stage III to stage IV (M0) CSCC of the head/neck, extremity, or trunk, and selected patients with stage II CSCC (≥3 cm longest diameter lesion in an aesthetically-sensitive region), for whom surgery is planned.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged at least 18 years
• ECOG performance Status of 0, 1, or 2
• Adequate baseline laboratory assessments within 28 days of study registration:
• Adequate hepatic function: i. Total bilirubin ≤1.5 x upper limit of normal (ULN) (NOTE: For patients with Gilbert's syndrome, total bilirubin ≤3 x ULN) ii. Transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) ≤3 x ULN iii. Alkaline phosphatase (ALP) ≤2.5 x ULN
• Adequate renal function: Serum creatinine ≤1.5 x ULN or estimated creatinine clearance (CrCl) \>30 mL/min according to the method of Cockcroft and Gault.
• Adequate bone marrow function: i. Hemoglobin ≥9.0 g/dL ii. Absolute neutrophil count (ANC) ≥1.0 x 109/L iii. Platelet count ≥75 x 109/L
• Patients who are HIV+ with undetectable HIV viral load are eligible.
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of cemiplimab administration.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

You may not qualify if:

• Concurrent malignancy other than localized CSCC and/or history of malignancy other than Merkel cell carcinoma within 3 years of date of registration on the study, except for tumors with negligible risk of metastasis or death, such as adequately treated (BCC) of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, or low- risk early stage prostate adenocarcinoma (T1-T2aN0M0 and Gleason score ≤6 and prostate-specific antigen (PSA) ≤10 ng/mL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of \>12 months for which the management plan is active surveillance.
• Patients with hematologic malignancies (eg, chronic lymphocytic leukemia \[CLL\]).
• Pregnancy or lactation.
• Has participated in a study of an investigational agent or an investigational device within weeks of the enrollment date.
• Receipt of a live vaccine within 28 days of the registration date.
• Has had prior systemic anti-cancer immunotherapy for MCC. Examples of immune modulating agents include but are not limited to blockers of CTLA-4, 4-1BB (CD137), or OX-40, therapeutic vaccines, anti-PD-1/PD-L1.
• Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab/placebo.
• NOTE: Patients who require brief course of corticosteroids (eg, prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded. People taking steroids for physiologic replacement (ie, adrenal insufficiency) are NOT excluded.
• NOTE: Patients receiving bisphosphonates or denosumab are not excluded.
• Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.
• Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to screening.
• Patients with myocardial infarction within 6 months prior to the registration date.
• Any infection requiring hospitalization and/or intravenous antibiotic therapy within 2 weeks of the registration date.
• Active tuberculosis.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Regeneron Pharmaceuticals: collaborator
• Sanofi-Synthelabo: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Carcinoma, Merkel Cell; Skin Neoplasms

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

• Ahmad Tarhini, MD, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 23, 2021
• Study Start: October 22, 2021
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)