Tremelimumab + Olaparib for Recurrent Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen BySarah 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.

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.

My condition worsened while I was on a PARP inhibitor treatment.

I can take care of myself and am up and about more than half of my waking hours.

I responded well to my last platinum-based cancer treatment without it getting worse.

My thyroid function is normal, with no symptoms of dysfunction.

I've had chemotherapy after my first-line maintenance therapy with a PARP inhibitor.

My cancer responds to platinum-based treatment and is a high-grade type in the ovary, peritoneum, or fallopian tube.

I am 18 years old or older.

My first cancer treatment included platinum-based drugs.

Exclusion Criteria

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

I have received anti-CTLA-4 antibody therapy before.

I haven't taken immunosuppressive drugs in the last 14 days.

I do not show signs of blood disorders like MDS or AML.

I have not had a blood transfusion in the last 28 days.

I have not received any live vaccines in the last 30 days.

I have not had any type of organ or tissue transplant from a donor.

I regularly take drugs that weaken my immune system for cancer or other illnesses.

I am not currently taking strong CYP3A4 inhibitors or inducers.

I do not have a bowel obstruction.

My ECG shows a QT interval over 470 msec, or I have a family history of long QT syndrome.

I stopped my cancer hormone therapy at least 28 days ago.

I have not had major surgery in the last 28 days.

I do not have significant liver disease like hepatitis or cirrhosis.

I do not have an active infection needing antibiotics, except for simple UTIs.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (olaparib, tremelimumab)Experimental Treatment4 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 Control4 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.

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lynparza for: