Tremelimumab + Olaparib for Recurrent Ovarian Cancer

Recruiting at 20 trial locations

Overseen by Sarah F Adams

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well olaparib with or without tremelimumab works in treating patients with ovarian, fallopian tube, or peritoneal cancer that has come back (recurrent). PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and tremelimumab together may work better than olaparib alone in treating patients with ovarian, fallopian tube, or peritoneal cancer.

Research Team

Sarah F Adams

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with recurrent high-grade ovarian, fallopian tube, or peritoneal cancer that's sensitive to platinum-based therapy. Participants must have a BRCA1/2 mutation and measurable disease. They should not have progressed on PARP inhibitors if used before and can't be pregnant. People with certain heart conditions, active infections, autoimmune diseases requiring recent treatment, or those on immunosuppressants are excluded.

Inclusion Criteria

My body weight is over 30 kg.

Your white blood cell count is at least 1,500 per microliter.

I have used a PARP inhibitor for my BRCA1 or BRCA2 mutation.

Exclusion Criteria

I have moderate to severe nerve pain or damage.

I have an autoimmune disease treated with medication in the last 2 years.

I do not have any serious ongoing illnesses that could affect my participation in the study.

Treatment Details

Interventions

• Olaparib (PARP Inhibitor)
• Tremelimumab (Monoclonal Antibodies)

Trial Overview The study is testing the effectiveness of combining Olaparib (a PARP inhibitor) with Tremelimumab (an immunotherapy drug) versus using Olaparib alone in patients whose cancer has returned. It aims to see if this combination helps the immune system better attack cancer cells and prevents them from repairing themselves.

Participant Groups

Group I: Arm II (olaparib, tremelimumab) Experimental Treatment 4 Interventions

Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

Group II: Arm I (olaparib) Active Control 4 Interventions

Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+