Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07594015
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Endometrial Cancer

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Participants will receive 200mg of Pembrolizumab intravenously on Day 1 of every 21 day cycle, as per standard of care and as per institutional guidelines.
  • Lenvatinib — DRUG
    Participants will self-administer Lenvatinib orally at a daily dose of 20mg or every 21 day cycle, as per standard of care and as per institutional guidelines.

Study Details

The purpose of this study is to determine the efficacy and safety of Pembrolizumab in combination with Lenvatinib in recurrent, mismatch repair-proficient endometrial cancer after failure of first-line therapy with a platinum-based doublet chemotherapy and immunotherapy.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2031
Completion
Jun 1, 2031

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab in combination with Lenvatinib
    Participants will receive Pembrolizumab in combination with Lenvatinib after failure of first-line therapy with a platinum-based doublet chemotherapy in combination with immunotherapy. Participants may receive treatment for a total of up to approximately 24 months, or until participants have progression of disease or experience a Grade 4 or higher severe adverse event (SAE). Total participation duration is approximately 26 months.

Primary Outcome Measure

Clinical Benefit Rate [ Time Frame: Baseline, Up to 18 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33146
Navya Nair, MD, MPH
[email protected]
305-243-2233
Abdulrahman Sinno, MD
[email protected]
305-243-2233
Navya Nair, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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