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  • Cancer Type: Cutaneous
  • Study Type: Treatment
  • NCT#: NCT04869137
  • Phase: Phase II
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  • Overview

    Study Title:

    Neoadjuvant Lenvatinib Plus Pembrolizumab in Resectable Merkel Cell Carcinoma


    This is a single arm trial of participants with Merkel cell carcinoma receiving a combination of lenvatinib plus pembrolizumab.


    Primary Objective - Assess the pathological complete response rate for resectable Merkel cell carcinoma treated with the combination of pembrolizumab and lenvatinib in the neoadjuvant setting. Secondary Objective - Assess the progression free survival of resectable Merkel cell carcinoma treated with neoadjuvant pembrolizumab and lenvatinib

  • Treatments




    E7080 (Lenvatinib); Lenvatinib (Lenvima); Pembrolizumab (Keytruda)

  • Inclusion Criteria

    • Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Merkel cell carcinoma will be enrolled in this study. The clinical stage of the patient must be stage II, III, or IV at the time of enrollment
    • Have clinically or radiographically detectable disease that is felt by the treating physician to be amenable to complete surgical resection
    • Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Be willing and able to perform home blood pressure monitoring
    • Have adequate organ function as defined by protocol
    • Male participants must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 days after the last dose of study treatment and refrain from donating sperm during this period.
    • Female participants are eligible to participate is they are not pregnant, not breastfeeding, and at least one of the following childbearing potential as defined by protocol:
    • A. Not a woman of childbearing potential as defined in protocol OR
    • B. A woman of childbearing potential who agrees to follow the contraceptive guidance per protocol during the treatment period and for at least 30 days after the last dose of the study treatment.
  • Exclusion Criteria

    • A WOCBP who has a positive urine pregnancy test
    • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
    • Has receive prior therapy with a systemic anti-VEGFR inhibitor for oncologic purposes
    • Uncontrolled blood pressure in spite of an optimized regimen of antihypertensive medication
    • Significant cardiovascular impairment defined by protocol
    • Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage
    • Participants having > 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is > Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to [randomization /allocation]
    • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (> Has received a live vaccine within 30 days prior to the first dose of study drug
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
    • Has known active CNS metastases and/or carcinomatous meningitis
    • Has severe hypersensitivity (>Grade 3) to pembrolizumab and/or any of its excipients
    • Has active autoimmune disease that has required systemic treatment in the past 2 years
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
    • Has an active infection requiring systemic therapy
    • Has a known history of HIV
    • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.

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