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Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer

NCT05296512 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-16

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Lenvatinib

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.

DRUG

Pembrolizumab

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.

Sponsors & Collaborators

Principal Investigators

  • Elizabeth K Lee, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2026-09-23
Completion
2028-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05296512 on ClinicalTrials.gov