Study on PARP Inhibitor and CTLA-4 Blocker for BRCA-Related Ovarian Cancer
Sponsor: New Mexico Cancer Research Alliance
ClinicalTrials ID:NCT02571725
This clinical trial is testing a new treatment combining a PARP inhibitor (Olaparib) and a CTLA-4 blocker (Tremelimumab) to see if it can safely and effectively treat women with recurrent ovarian cancer linked to BRCA gene mutations.
Patient Parameters
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Program Overview
Ovarian cancer affects about 21,000 women in the U.S. each year, with 10% of cases linked to inherited gene mutations, particularly in the BRCA1 or BRCA2 genes. These mutations hinder the repair of DNA damage in cells. PARP inhibitors, like Olaparib, target these cancer cells by blocking another DNA repair pathway, which can lead to cancer cell death. While PARP inhibitors have improved the time patients live without the cancer getting worse, they haven't increased overall survival. Some studies suggest that combining PARP inhibitors with immune system treatments, like CTLA-4 blockers, might improve long-term survival. This study aims to test the safety and effectiveness of combining Olaparib with Tremelimumab in women with recurrent ovarian cancer linked to BRCA mutations.
Description
Olaparib is a drug that blocks certain proteins (PARP-1, PARP-2, and PARP-3) involved in repairing DNA damage in cells. In cancers with BRCA mutations, this can lead to cancer cell death. Tremelimumab is an antibody that helps the immune system attack cancer cells by blocking a protein called CTLA-4, which normally helps keep the immune system in check. By blocking CTLA-4, Tremelimumab may help the immune system better fight cancer. This study is testing whether combining these two drugs can improve outcomes for women with BRCA-related ovarian cancer. Previous studies in mice have shown promising results, and this trial will evaluate if the combination is safe and effective in humans.
Eligibility Criteria
Inclusion Criteria
- Women with recurrent ovarian, fallopian tube, or primary peritoneal cancer that cannot be cured with standard treatments.
- Must have a confirmed BRCA1 or BRCA2 gene mutation.
- Must have measurable cancer that can be tracked using scans or exams.
- Can have cancer that is sensitive or resistant to platinum-based chemotherapy.
- Must have had at least one prior treatment with platinum-based chemotherapy.
- No limit on the number of previous treatments.
- Must be in good overall health with a performance status of 0, 1, or 2.
- Must have adequate blood counts and organ function.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
- Must be able to understand and sign a consent form.
- Must meet specific pre-entry requirements.
Exclusion Criteria
- Must have recovered from recent surgery, radiation, or chemotherapy.
- No active infections requiring antibiotics, except simple urinary tract infections.
- Must stop any cancer hormone therapy at least one week before joining the study.
- Must stop any other cancer treatments at least three weeks before joining the study.
- Must stop any radiation therapy at least four weeks before joining the study.
- Cannot have autoimmune disorders or conditions needing immune-suppressing drugs.
- Cannot have HIV or other immune deficiencies.
- Cannot have allergies to similar drugs used in the study.
- Cannot have uncontrolled illnesses or psychiatric conditions that affect study participation.
- Cannot use certain medications that affect drug metabolism.
- Cannot have severe side effects from previous cancer treatments.
- Cannot be pregnant or breastfeeding.
- Cannot be in another clinical trial.
- For Phase 2, additional exclusions include heart rhythm issues or previous treatment with CTLA-4 blockers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Southwest Gynecologic Oncology Associates | 87106 | Albuquerque | New Mexico |
| University of New Mexico Comprehensive Cancer Center | 87131 | Albuquerque | New Mexico |
| The Ohio State University | 43210 | Columbus | Ohio |
| University of Virginia Cancer Center | 22903 | Charlottesville | Virginia |
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