Pembrolizumab for Recurrent Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Gottfried E. Konecny, MD - Gynecologic ...

Overseen byGottfried Konecny, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well pembrolizumab works in treating participants with ovarian cancer that has come back after previous treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Eligibility Criteria

This trial is for individuals with recurrent ovarian cancer, including peritoneal and fallopian tube cancers. Participants must have had 1-5 previous treatments, a gap of at least 3 months since the last treatment, be in good physical condition (ECOG 0 or 1), and have adequate organ function. Women of childbearing age must agree to use contraception during the study and for four months after.

Inclusion Criteria

Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

My white blood cell count is high enough for treatment.

Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

+15 more

Exclusion Criteria

I have recovered from any major surgery before starting treatment.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have or had lung inflammation not caused by an infection.

+18 more

Participant Groups

The trial is testing Pembrolizumab, a monoclonal antibody designed to block cancer growth by interfering with tumor cells' ability to evade immune detection. It's given to participants whose ovarian cancer has returned despite prior treatments.

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention

Participants receive pembrolizumab intravenously IV on day 1. Courses repeat every 3 weeks for up to 35 courses (2 years) in the absence of disease progression or unacceptable toxicity.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: