Pembrolizumab and Lenvatinib in Advanced Cervical Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT04865887
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200mg, every 3 weeks, IV infusion
  • Lenvatinib — DRUG
    20 mg (2 capsules x10mg), daily, orally

Study Details

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.

Key Dates

Start date
Oct 7, 2022
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab with Lenvatinib

Primary Outcome Measure

Objective Response Rate [ Time Frame: up to 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Jamie Magnanti
202-687-3937
Samir Khleif, MD (PRINCIPAL_INVESTIGATOR)
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912
Emily Sarria
706-721-5557
Sharad Ghamande, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer Center at Hackensack UMCHackensackNew Jersey07601
Oncology Clinical Research Referral Office
551-996-1777
Donna McNamara, MD (PRINCIPAL_INVESTIGATOR)

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