Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Elizabeth K. Lee MD
Study ID
NCT05296512
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Gynecologic Cancer
  • Ovarian Clear Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Lenvatinib — DRUG
    Lenvatinib is an oral capsule medication that will be taken by mouth once daily, every day of each 21-day treatment cycle. Treatment will be administered on an outpatient basis.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered intravenously (IV) on Day 1 of every 21-day treatment cycle. Treatment will be administered on an outpatient basis. Pembrolizumab will be given up to 35 cycles (approximately 24 months). Participants who stop pembrolizumab treatment with SD or better may be eligible for up to an additional 17 cycles (approximately 12 months) of pembrolizumab treatment ("Pembrolizumab Re-Treatment") if they progress after stopping pembrolizumab and while receiving lenvatinib.

Study Details

This research study is being done to test the efficacy and safety of combining the study drugs pembrolizumab and lenvatinib in patients with clear cell ovarian cancer. The names of the study drugs involved in this study are: * Lenvatinib * Pembrolizumab

Key Dates

First listed
Mar 25, 2022
Start date
Sep 23, 2022
Status verified
Dec 2025
Primary completion
Sep 23, 2026
Completion
Nov 15, 2028

Study Design

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

Arms

  • Experimental: PEMBROLIZUMAB and LENVATINIB
    The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The names of the study drugs involved in this study are: * Lenvatinib * Pembrolizumab Treatment will continue until progression of disease or unacceptable toxicity. Participants will be followed for up to 36 months after discontinuation of study treatment.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: ORR expected to be observed up to 3 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Chicago MedicineChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Mayo Clinic Comprehensive Cancer CenterRochesterMinnesota55905-

Find similar trials in Chicago, IL

By research site
University of Chicago Medicine· Chicago, ILDana Farber Cancer Institute· Boston, MAMayo Clinic Comprehensive Cancer Center· Rochester, MN

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