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Pembrolizumab and Lenvatinib in Patients With High Risk Locally Advanced Cervix Cancer

NCT07368985 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-01-27

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the combination of Pembrolizumab and Lenvatinib works to treat locally advanced cervical cancer in adults that will undergo primary chemoradiation and brachytherapy. It will also learn about the safety of the combination of Pembrolizumab and Lenvatinib. The main questions it aims to answer are:

* Does the combination of Pembrolizumab and Lenvatinib improve progression free survival at two years after treatment?
* What side effects do participants have when taking the combination of Pembrolizumab and Lenvatinib? Researchers will compare the combination of Pembrolizumab and Lenvatinib to existing results with primary chemoradiatoin and brachytherapy to see if the combination of Pembrolizumab and Lenvatinib works to treat locally advanced cervical cancer.

Participants will:

* Visit the clinic to receive Pembrolizumab intra venously once every 3 weeks for 5 cycles and then once very 6 weeks for a maximum of 2-years
* Take Lenvatinib orally every day starting at the earliest 8 weeks after the last brachytherapy to a maximum of 1 year
* Visit the clinic for checkups and tests during scheduled visits

Conditions

  • Cervical Cancer by FIGO Stage 2018
  • Squamous Cell Carcinoma FIGO 2018 Stage IIIA, IIIB, IIIC1-IIIC2
  • Adenocarcinoma or Adeno-squamous Carcinoma Stage IB3-IIIC2

Interventions

DRUG

pembrolizumab and lenvatinib

Patients will undergo standard of care chemoradiation (CRT: combined external beam radiotherapy with weekly cisplatin) followed by MRI guided brachytherapy, this will be combined with the following study drugs: Pembrolizumab: 5 intravenous administrations of Pembrolizumab (200 mg) every 3 weeks with the first administration at the start of chemoradiotherapy, followed by subsequent doses of 400 mg IV Pembrolizumab at 6 weeks intervals, starting week 16 up to week 102 with a maximum of 15 cycles. Lenvatinib: the combination with Lenvatinib will start after recovery, along with the 6 weekly cycles of Pembrolizumab, e.g. around 8-9 weeks after brachytherapy (week 16), at a dose of 20 mg daily oral and will continue up to week 48.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-10-31
Completion
2029-10-31
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07368985 on ClinicalTrials.gov