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Study of Pembrolizumab and Lenvatinib for Cervical Cancer

This study is looking at how a combination of two drugs, pembrolizumab and lenvatinib, might help treat cervical cancer that has come back or spread. Pembrolizumab is a checkpoint inhibitor, which means it helps your immune system fight cancer. You may be able to join if you are a woman at least 18 years old with recurrent or metastatic (spread) cervical cancer. The researchers want to see if this drug combination can shrink tumors. The study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. The study will look at how well the drug combination works.
What's involved
You would receive pembrolizumab intravenously (through a vein) every 3 weeks and take lenvatinib by mouth daily. This treatment could last for up to 35 cycles of pembrolizumab, with a possibility of more if needed.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works for up to approximately 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06266338

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~30 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:PembrolizumabLenvatinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1
Measured over Baseline up to approximately 36 months

Conditions

Cervix Cancer
Cervical Cancer

Explore related trials

Cervical CarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Jayanthi Lea, MD · PRINCIPAL_INVESTIGATOR · Professor and Division Chief, Obstetrics & Gynecology, OB-Gynecologic Oncology

Who to contact

Annette Paulsen
[email protected]
214-645-7097
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP)
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. 8. Participants must have a PD-L1 diagnostic test of primary or recurrent archival tumor tissue. 9. Participants may have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all the following criteria:
Known history of HBV or HCV infection
As mandated by local health authority 17. Hepatitis B positive subjects
Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. 18. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.

Exclusion

Known history of HBV and HCV infection
As mandated by local health authority 15. Has had major surgery within three weeks prior to first dose of study interventions.

What this trial measures

  • Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1Baseline up to approximately 36 months

    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.