Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants who are at least 18 years of age on the day of signing informed consent.
Histologically confirmed diagnosis of squamous, adenocarcinoma or adenosquamous cervical cancer, that is recurrent or metastatic.
Prior therapy: May have received up to 2 prior lines of systemic chemotherapy in the setting of advanced, metastatic (Stage IVB) or recurrent cervical cancer. May have received prior checkpoint inhibitor for advanced, metastatic (Stage IVB) or recurrent cervical cancer. May have received prior bevacizumab or antiangiogenic agent for recurrent or metastatic cervical cancer,
Include whether prior checkpoint inhibitor was used in first line setting or second line setting.
Disqualifiers
A WOCBP who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
Drug200 mg IV q 3 weeks
Lenvatinib
Drug20 mg PO daily
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab and Lenvatinib ArmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1
Objective Response (ORR) is defined as a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to Recist (Response Evaluation Criteria in Solid Tumors) v1.1.
Time frame
Baseline up to approximately 36 monthsSecondary outcomes
1
Progression Free Survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors v1.1
Safety and tolerability of lenvatinib and pembrolizumab after prior checkpoint inhibitor and/or other prior treatment. Adverse events will be assessed as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Time frame
PFS is defined as the time from the first dose date until the date of the first documented disease progression, or death up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov