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Pembrolizumab and Lenvatinib Arm for Cervical Cancer

Phase 2

Recruiting

Led By Jayanthi Lea, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of squamous, adenocarcinoma or adenosquamous cervical cancer, that is recurrent or metastatic

Female participants must not be pregnant, not breastfeeding, and meet contraceptive requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 36 months

Awards & highlights

Study Summary

"This trial aims to study a new drug combination of Lenvatinib and pembrolizumab to see if it can slow down the growth of cervical cancer tumors."

Who is the study for?

This trial is for individuals with cervical cancer that has spread (metastatic) or come back (recurrent). Participants should meet certain health standards, but specific inclusion and exclusion criteria are not listed.Check my eligibility

What is being tested?

The study is testing a combination of two drugs, Lenvatinib and Pembrolizumab, to see if they can slow down the growth of tumors in patients with cervical cancer.See study design

What are the potential side effects?

While specific side effects are not detailed here, Pembrolizumab may cause immune system reactions or infusion-related symptoms. Lenvatinib might lead to high blood pressure, fatigue, and digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cervical cancer has returned or spread and is confirmed by a biopsy.

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I am not pregnant, not breastfeeding, and follow birth control guidelines.

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My side effects from previous cancer treatments have mostly gone away.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have Hepatitis B but am on antiviral therapy with an undetectable viral load.

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My blood pressure is under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1

Secondary outcome measures

Progression Free Survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors v1.1

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab and Lenvatinib ArmExperimental Treatment2 Interventions

Pembrolizumab 200 mg q 3 weeks IV Lenvatinib 20 mg PO QD Continue q3 weeks Pembrolizumab and Lenvatinib will be given together in this trial for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing and Lenvatinib daily. Participants who complete study intervention after 2 years of pembrolizumab and lenvatinib are eligible for up to 1 year of additional pembrolizumab and lenvatinib (second course) upon experiencing disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2005

Completed Phase 4

~2690

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,116 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,705 Total Patients Enrolled

Jayanthi Lea, MDPrincipal InvestigatorProfessor and Division Chief, Obstetrics & Gynecology, OB-Gynecologic Oncology

3 Previous Clinical Trials

26 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"As per clinicaltrials.gov, this particular investigation is not currently seeking volunteers. Initially shared on 4/1/2024 and most recently revised on 2/9/2024, it remains inactive in terms of participant recruitment. Nonetheless, there are a noteworthy 419 other ongoing studies that are actively enrolling patients at present."

Answered by AI

What is the safety profile of the combination treatment involving Pembrolizumab and Lenvatinib for individuals?

"The safety assessment for the Pembrolizumab and Lenvatinib Arm was rated as 2 by our team at Power on a scale of 1 to 3. This rating is due to being in Phase 2, where there exists some data supporting safety but efficacy evidence is lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jayanthi Lea 2024. "Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06266338.

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