NCT06266338

Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)

A Phase 2A, Prospective, Open Label, Single Institution Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to gather information about an investigational drug combination, Lenvatinib in combination with pembrolizumab, that may help to treat cervical cancers. In this study, we are looking to see whether the combination of lenvatinib and pembrolizumab has any effect on slowing tumor growth in cervical cancer tumors.

Detailed description

Dose of pembrolizumab : The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). for a total of 35 cycles of pembrolizumab. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression. Lenvatinib Dosing Regimen: lenvatinib 20 mg/day plus pembrolizumab 200 mg Q3W.

Conditions

• Cervix Cancer
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg IV q 3 weeks
DRUG	Lenvatinib	20 mg PO daily

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2024-02-20
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study