drugset / Trial / NCT07368985

Pembrolizumab and Lenvatinib in Patients With High Risk Locally Advanced Cervix Cancer

NCT07368985 ↗

Phase 2 Not yet recruiting 87 enrolled Prof. Dr. Remi A. Nout Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if the combination of Pembrolizumab and Lenvatinib works to treat locally advanced cervical cancer in adults that will undergo primary chemoradiation and brachytherapy. It will also learn about the safety of the combination of Pembrolizumab and Lenvatinib. The main questions it aims to answer are: * Does the combination of Pembrolizumab and Lenvatinib improve progression free survival at two years after treatment? * What side effects do participants have when taking the combination of Pembrolizumab and Lenvatinib? Researchers will compare the combination of Pembrolizumab and Lenvatinib to existing results with primary chemoradiatoin and brachytherapy to see if the combination of Pembrolizumab and Lenvatinib works to treat locally advanced cervical cancer. Participants will: * Visit the clinic to receive Pembrolizumab intra venously once every 3 weeks for 5 cycles and then once very 6 weeks for a maximum of 2-years * Take Lenvatinib orally every day starting at the earliest 8 weeks after the last brachytherapy to a maximum of 1 year * Visit the clinic for checkups and tests during scheduled visits

Timeline

Start
2026-03
Primary completion
2029-10
Completion
2029-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 20 mg Oral
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous