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
- Cervical Cancer
- Metastatic Cervical Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pembrolizumab — DRUG200mg, every 3 weeks, IV infusion
- Lenvatinib — DRUG20 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | Samir Khleif, MD (PRINCIPAL_INVESTIGATOR) |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | - |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | Sharad Ghamande, MD (PRINCIPAL_INVESTIGATOR) |
| John Theurer Cancer Center at Hackensack UMC | Hackensack | New Jersey | 07601 | Donna McNamara, MD (PRINCIPAL_INVESTIGATOR) |
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