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New treatment option for Merkel Cell Carcinoma, Stage I
Official title Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab
ClinicalTrials.gov ID: NCT07387198
What this study is testing
What is Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles?
Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles is an investigational medicine, being studied as a potential treatment for merkel cell carcinoma, stage i.
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 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- 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...
- Patient has ECOG performance status 0-2.
- Patients has adequate laboratory parameters particularly for the blood count, renal and liver function parameters.
You likely can't join 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...
- Patient has active or a history of hematological neoplasms including chronic lymphocytic leukemia (CLL), irrespective if these require treatment or...
- 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...
- Patient has known hypersensitivity to any component of the Cemiplimab formulation as well as a known history of severe allergic, anaphylactic, or...
See the full eligibility criteria
- 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...
- Patient must be willing to allow translational work-up of tissue samples (PT, sentinel lymph node biopsy).
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
- Mannheim, Baden-Wurttemberg, Germany
- Tübingen, Baden-Wurttemberg, Germany
- Regensburg, Bavaria, Germany
- Würzburg, Bavaria, Germany
- Hamburg, Free and Hanseatic City of Hamburg, Germany
- Frankfurt am Main, Hesse, Germany
- Bielefeld, North Rhine-Westphalia, Germany
- Cologne, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Minden, North Rhine-Westphalia, Germany
- Mainz, Rhineland-Palatinate, Germany
- Leipzig, Saxony, Germany
- Erfurt, Thuringia, Germany
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 Heidelberg, Baden-Wurttemberg, Germany; Mannheim, Baden-Wurttemberg, Germany; Tübingen, Baden-Wurttemberg, Germany; Regensburg, Bavaria, Germany; Würzburg, Bavaria, Germany; Hamburg, Free and Hanseatic City of Hamburg, Germany and 8 more location(s). 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.