PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer (NCT02571725)
A Phase 1-2 Study of the Combination of Olaparib and Tremelimumab, in BRCA1 and BRCA2 Mutation Carriers With Recurrent Ovarian Cancer
๐ฉบ Plain-English Summary (8th-Grade Level)
Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten percent are attributed to hereditary syndromes, most commonly the result of mutations in the breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results in the inability to repair double-stranded breaks in DNA. Treating these tumors with poly(adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitors results in the specific killing of BRCA negative cells by blocking a second DNA-repair mechanism. Treatment of ovarian cancer patients with PARP inhibitors has resulted in improved progression free survival (PFS), but not overall survival (OS). It's not completely understood why this is the case, but some preclinical studies using ovarian cancer models in mice have suggested that combining PARP inhibitors with immune system modulators like T cell checkpoint inhibitors improves long-term survival. Therefore, the purpose of this study is to evaluate the safety and efficacy of a combination of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.
Who can join: Review the eligibility criteria below.
Location: Moffitt Cancer Center โ Tampa, Florida
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (5 Sites)
- Moffitt Cancer Center โ Tampa, Florida
- Southwest Gynecologic Oncology Associates โ Albuquerque, New Mexico
- University of New Mexico Comprehensive Cancer Center โ Albuquerque, New Mexico
- The Ohio State University โ Columbus, Ohio
- University of Virginia Cancer Center โ Charlottesville, Virginia
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ovarian Cancer
- Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy โ New York, New York
- Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer โ Pittsburgh, Pennsylvania
- Trial on Radical Upfront Surgery in Advanced Ovarian Cancer โ New York, New York
- Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) โ Duarte, California
- Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) โ Little Rock, Arkansas
- NeoVax With Nivolumab in Patients With Ovarian Cancer โ Boston, Massachusetts
Explore by condition: All Ovarian Cancer clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.