PARP Inhibitor + CTLA-4 Blockade for Ovarian Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: New Mexico Cancer Care Alliance

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sarah F. Adams

Principal Investigator

University of New Mexico Comprehensive Cancer Center

Eligibility Criteria

This trial is for women with recurrent ovarian cancer linked to BRCA mutations, who've had platinum-based chemo. They must have good organ function and a performance status of 0-2, indicating they can carry out daily activities with varying degrees of assistance. Participants need measurable disease and cannot be on other cancer treatments or have autoimmune diseases, uncontrolled illnesses, or known allergies to the drugs being tested.

Inclusion Criteria

Patients must meet pre-entry requirements as specified

My organs and bone marrow are functioning well.

My ovarian, fallopian tube, or peritoneal cancer has returned and cannot be cured with standard treatments.

Exclusion Criteria

I stopped my cancer hormone therapy at least a week ago.

You have HIV or other immune system problems.

I stopped all cancer treatments at least 3 weeks ago.

Treatment Details

Interventions

• Olaparib (PARP Inhibitor)
• Tremelimumab (Checkpoint Inhibitor)

Trial Overview The study tests Olaparib (a PARP inhibitor) combined with Tremelimumab (an anti-CTLA-4 antibody) in treating BRCA mutation-associated ovarian cancer. It aims to see if this combo improves survival rates by targeting DNA repair mechanisms in cancer cells while also stimulating the immune system.

Participant Groups

Group I: Olaparib and Tremelimumab Experimental Treatment 2 Interventions

Each cycle is 28 days: Olaparib at 300 mg, orally, twice daily + Tremelimumab at 10 mg/kg, intravenously, every 4 weeks for the first 6 doses, then every 12 weeks until disease progression or unacceptable toxicity. * If 1 of the first 3 patients experiences a regimen-limiting toxicity (RLT), 3 more patients will be treated with 10 mg/kg Tremelimumab in Phase 1. If 2 or more of 6 patients experience RLT, then 6 mg/kg Tremelimumab will be tested * If at 6 mg/kg, 1 or more of 3 patients experience RLT, 3 patients will be treated at 3 mg/kg Tremelimumab * If at 3 mg/kg, 1 or more patients experience RLT, the study will be discontinued for safety purposes In Phase 2, patients will receive doses of Olaparib and Tremelimumab determined in the Phase 1 portion as described above, based on tolerability.

Who Is Running the Clinical Trial?

New Mexico Cancer Care Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

New Mexico Cancer Research Alliance

Lead Sponsor

Trials

71

Recruited

52,500+