NCT05296512

Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer

A Phase II Trial of Pembrolizumab and Lenvatinib in Patients With Recurrent or Persistent Clear Cell Carcinoma of the Ovary

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Elizabeth K. Lee MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is an open label, non-randomized, single cohort phase II trial. Participants with recurrent or persistent clear cell ovarian carcinoma (CCOC) will be treated with the investigational combination of pembrolizumab and lenvatinib until progression of disease or unacceptable toxicity. The names of the study drugs involved in this study are: * Lenvatinib * Pembrolizumab The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment until progression of disease or unacceptable toxicity. Participants will be followed for 36 months thereafter. It is expected that about 31 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drugs work in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved lenvatinib or pembrolizumab for your specific disease but it has been approved for other uses.

Conditions

• Ovarian Clear Cell Carcinoma
• Gynecologic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-23
• Primary completion: 2026-09-23
• Completion: 2028-11-15
• First posted: 2022-03-25
• Last updated: 2025-12-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study