Study on Adding Immunotherapy Drug Tremelimumab to Olaparib for Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04034927
This clinical trial is exploring whether combining the immunotherapy drug tremelimumab with the PARP inhibitor olaparib can better treat ovarian, fallopian tube, or peritoneal cancer that has returned after treatment.
Patient Parameters
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Program Overview
This study is testing if the combination of two drugs, olaparib and tremelimumab, can more effectively treat ovarian, fallopian tube, or peritoneal cancer that has come back. Olaparib is a drug that stops cancer cells from repairing themselves, while tremelimumab helps the immune system attack cancer cells. The trial aims to see if using both drugs together works better than using olaparib alone.
Description
The study has two main goals: to ensure the safety of using olaparib with tremelimumab and to compare how long patients live without their cancer getting worse when treated with either olaparib alone or with both drugs. Researchers will also look at how well the cancer responds to treatment and overall survival rates.
Participants will be divided into two groups. One group will receive olaparib alone, while the other group will receive both olaparib and tremelimumab. Olaparib is taken orally twice a day, and tremelimumab is given through an IV every four weeks for the first four doses, then every 12 weeks for up to two years. Patients will have regular scans and blood tests to monitor their progress.
After finishing the treatment, participants will have follow-up visits monthly for three months, then every three months for two years, and every six months for three more years.
Eligibility Criteria
Inclusion Criteria
- Have recurrent ovarian, fallopian tube, or peritoneal cancer that is sensitive to platinum-based treatments.
- Have a BRCA1 or BRCA2 mutation if diagnosed with a different type of cancer.
- Cancer must not have returned for at least six months after the last platinum-based treatment.
- Must have had a positive response to previous platinum-based treatment.
- Must have measurable cancer according to specific criteria.
- Must be 18 years or older and weigh more than 30 kg.
- Must have good overall health with specific blood counts and organ function.
- Must be able to swallow pills and not have digestive issues that affect absorption.
- Women must not be pregnant and must use effective birth control during and after the study.
- Must have a life expectancy of at least 12 weeks.
- Must not have active brain metastases unless treated and stable.
- HIV-positive patients must have an undetectable viral load.
- Must provide informed consent to participate.
Exclusion Criteria
- Have an active infection requiring antibiotics.
- Have significant liver disease or untreated hepatitis.
- Have received cancer treatment within 28 days before starting the study.
- Have had major surgery within 28 days before starting the study.
- Are using immunosuppressive medication within 14 days before starting the study.
- Have an autoimmune disease requiring treatment in the past two years.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled health conditions that could interfere with the study.
- Are pregnant or breastfeeding.
- Have received a live vaccine within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| Hartford Hospital | 06102 | Hartford | Connecticut |
| Augusta University Medical Center | 30912 | Augusta | Georgia |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| University of New Mexico Cancer Center | 87106 | Albuquerque | New Mexico |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| UHHS-Chagrin Highlands Medical Center | 44122 | Beachwood | Ohio |
| Case Western Reserve University | 44106 | Cleveland | Ohio |
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