Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma (NCT04869137) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma
United States26 participantsStarted 2021-05-28
Plain-language summary
This is a single arm trial of participants with Merkel cell carcinoma receiving a combination of lenvatinib plus pembrolizumab.
Who can participate
Age range18 Years
SexALL
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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 (AJCC 8th edition) at the time of enrollment.
* Male participants:
* A male participant must agree to use contraception 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:
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance in protocol during the treatment period and for at least 30 days after the last dose of study treatment.
* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
* 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. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
* Have an Eastern Cooperative Onco…
What they're measuring
1
Pathological Complete Response
Timeframe: 1 year
Trial details
NCT IDNCT04869137
SponsorH. Lee Moffitt Cancer Center and Research Institute