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New treatment option for Merkel Cell Carcinoma
Official title Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT04975152
What this study is testing
What is Cemiplimab-Rwlc?
Cemiplimab-Rwlc is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for merkel cell carcinoma.
Also referred to as Libtayo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients must be considered candidates for wide local surgical excision and may be candidates for sentinel lymph node biopsy. If sentinel biopsy is...
- 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...
- Provision of signed and dated informed consent form
You likely can't join if
- Concurrent malignancy other than localized CSCC and/or history of malignancy other than Merkel cell carcinoma within 3 years of date of registration...
- Patients with hematologic malignancies (eg, chronic lymphocytic leukemia [CLL]).
- Ongoing or recent (within 5 years of registration date) evidence of significant autoimmune disease that required treatment with systemic...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
What rules you out
- 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...
- Patients with hematologic malignancies (eg, chronic lymphocytic leukemia [CLL]).
- Ongoing or recent (within 5 years of registration date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse...
- 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...
- 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.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency. NOTES:
- Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with...
- Patients with HBV (hepatitis B surface antigen positive; HepBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection AND receiving anti- viral therapy for HBV) are permitted. Patients...
- History of immune related pneumonitis within the last 5 years.
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A...
- History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.
- Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.
- Patients with a history of solid organ transplant (exception: patients with prior corneal transplant are not excluded).
- Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that, in the opinion of the investigator, renders the patient unsuitable for participation in a...
- Known psychiatric or substance abuse disorders that would interfere with participation with the requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.