Study on Pembrolizumab for Treating Recurrent Ovarian Cancer
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT03732950
This clinical trial is exploring how well the drug pembrolizumab works in treating ovarian cancer that has returned after previous treatments. Pembrolizumab is a type of medication that may help stop cancer cells from growing and spreading.
Patient Parameters
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Program Overview
The purpose of this study is to see if pembrolizumab, a type of monoclonal antibody, can effectively treat ovarian cancer that has come back after previous treatments. The study will look at how well the drug works in shrinking tumors and how long patients can live without the cancer getting worse. It will also assess the safety and side effects of pembrolizumab when used alone.
Description
This study aims to evaluate the effectiveness of pembrolizumab in patients with recurrent ovarian cancer. The main goal is to see how well the drug works in shrinking tumors, as measured by specific criteria. Researchers will also look at how long patients can live without the cancer progressing and assess the safety and side effects of the treatment.
Participants will receive pembrolizumab through an IV every three weeks for up to two years, as long as the cancer does not worsen and there are no severe side effects. After finishing the treatment, participants will have follow-up visits to monitor their health.
The study will also explore the relationship between certain genetic markers in the tumors and the effectiveness of pembrolizumab.
Eligibility Criteria
Inclusion Criteria
- Be willing and able to provide written consent to participate.
- Have received 1-5 previous treatments for recurrent ovarian cancer and have had a break of at least 3 months since the last treatment.
- Have measurable cancer that can be tracked using standard criteria.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a confirmed diagnosis of recurrent ovarian, fallopian, or primary peritoneal cancer.
- Provide a tumor tissue sample for analysis.
- Have adequate blood cell counts and organ function as determined by specific tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for 120 days after the last dose.
Exclusion Criteria
- Currently participating in another study or have recently received an investigational treatment.
- Have a diagnosis of immunodeficiency or are taking immunosuppressive medications.
- Have a history of active tuberculosis.
- Have allergies to pembrolizumab or its ingredients.
- Have received certain cancer treatments recently and have not fully recovered from side effects.
- Have another active cancer that requires treatment, except for certain skin cancers or in situ cervical cancer.
- Have active brain metastases or cancer in the brain lining.
- Have an active autoimmune disease requiring treatment in the past two years.
- Have a history of lung inflammation or active infections requiring treatment.
- Have any condition that might interfere with the study or are not in the best interest to participate.
- Are pregnant or breastfeeding, or planning to conceive during the study period.
- Have received prior therapy with similar drugs to pembrolizumab.
- Have a history of HIV or active hepatitis B or C.
- Have received a live vaccine recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | 90095 | Los Angeles | California |
| University of Minnesota/Masonic Cancer Center | 55455 | Minneapolis | Minnesota |
| Mayo Clinic | 55905 | Rochester | Minnesota |
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