Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT04865887

Pembrolizumab and Lenvatinib in Advanced Cervical Cancer

Led by Georgetown University · Updated on 2025-10-07

35

Participants Needed

4

Research Sites

194 weeks

Total Duration

On this page

Sponsors

G

Georgetown University

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a phase II trial of combination therapy of pembrolizumab and lenvatinib in patients with locally advanced or metastatic cervical cancer that had failed first line of therapy. The hypothesis is the combination of lenvatinib and pembrolizumab will overcome vascular endothelial growth factor (VEGF)-mediated immunosuppression to enhance the response of patients with locally advanced or metastatic cervical cancer.

CONDITIONS

Official Title

Pembrolizumab and Lenvatinib in Advanced Cervical Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants at least 18 years old with confirmed locally advanced or metastatic cervical cancer
  • Progression or intolerance to at least one prior therapy in the locally advanced or metastatic setting
  • Female participants not pregnant, not breastfeeding, and either not of childbearing potential or agreeing to contraceptive guidance during treatment and for 120 days after last dose
  • Provide written informed consent
  • Have measurable disease based on RECIST 1.1 criteria
  • Provide archival tumor tissue or a new biopsy sample not previously irradiated
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Adequate organ function as defined by specific blood count and chemistry criteria measured within 28 days before treatment
Not Eligible

You will not qualify if you...

  • Positive pregnancy test within 72 hours prior to treatment start or pregnancy during study
  • Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
  • Prior systemic anti-cancer therapy including investigational agents within 4 weeks unless recovered from side effects
  • Prior radiotherapy within 2 weeks before treatment without recovery from toxicities
  • Receipt of live or live attenuated vaccines within 30 days prior to first study drug dose
  • Participation in another investigational study or use of investigational devices within 4 weeks
  • Immunodeficiency or recent use of systemic immunosuppressive therapy within 7 days
  • Active additional malignancy requiring treatment within past 3 years (except certain skin and in situ cancers)
  • Active central nervous system metastases or carcinomatous meningitis without stability
  • Severe hypersensitivity to pembrolizumab, lenvatinib, or their components
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History or current pneumonitis or interstitial lung disease requiring steroids
  • Active infection requiring systemic therapy
  • Known HIV, active Hepatitis B or C infection
  • Conditions or treatments that interfere with study participation or results
  • Psychiatric or substance abuse disorders affecting cooperation
  • Pregnant, breastfeeding, or planning pregnancy during study
  • Uncontrolled high blood pressure despite medication
  • Uncorrected electrolyte abnormalities
  • Significant cardiovascular impairment or recent major cardiac events
  • Bleeding or clotting disorders or risk of severe hemorrhage
  • Proteinuria greater than 1+ on urine dipstick unless quantified below 1 g/24 hours
  • Gastrointestinal conditions affecting absorption of lenvatinib
  • Prolonged QTc interval over 480 ms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

2

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Withdrawn

3

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

4

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States, 07601

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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