Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04869137
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Merkel Cell Carcinoma
  • Neuroendocrine Carcinoma of the Skin
  • Trabecular Carcinoma of the Skin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib Oral Product — DRUG
    20mg of Lenvatinib will be taken orally once daily
  • Pembrolizumab — DRUG
    200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.

Study Details

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

Key Dates

Start date
May 28, 2021
Status verified
Mar 2026
Primary completion
Sep 13, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib plus Pembrolizumab
    Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.

Primary Outcome Measure

Pathological Complete Response [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-

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By research site
Moffitt Cancer Center· Tampa, FL

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