Spots Global Cancer Trial Database for Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
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Trial Identification
Brief Title: Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
Official Title: A Phase 2A, Prospective, Open Label, Single Institution Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
Study ID: NCT06266338
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UT Southwestern Medical Center, Dallas, Texas, United States
Contact Details
Name: Jayanthi Lea, MD
Affiliation: Professor and Division Chief, Obstetrics & Gynecology, OB-Gynecologic Oncology
Role: PRINCIPAL_INVESTIGATOR
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