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Recruiting Phase 2 NCT04519151

Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer

Trial Parameters

Condition Ovarian Neoplasms
Sponsor Sheba Medical Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 24
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2021-04-12
Completion 2023-11
Interventions
PembrolizumabLenvatinib

Brief Summary

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.

Eligibility Criteria

Inclusion Criteria: 1. Female participants who are at least 18 years of age on the day of signing informed consent, with histologically-confirmed diagnosis of EOC (except from low grade tumors and mucinous histology). 2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive during the treatment period and for at least 120 days after the last dose of study treatment. 3. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 4. Have measurable disease at baseline based on RECIST 1.1. Lesions 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. Have received a front-line platinum-based regimen per local standard of care or treatment guideline following the primary or interval debunking surgery with radiol

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