Triple Combination Immunotherapy for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+429 other locations

Overseen byJung-min Lee

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

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and cediranib may work better in increasing the duration of time that the cancer does not progress compared to the usual treatment.

Eligibility Criteria

This trial is for women with certain types of ovarian, fallopian tube, or peritoneal cancer that has returned after platinum therapy. Participants must have had at least two prior treatments and can have had bevacizumab, PARP inhibitors, or immune checkpoint blockade. They should not have primary platinum-refractory disease or a history of severe bowel issues within the last 3 months.

Inclusion Criteria

I have previously used a PARP inhibitor.

Side effects from my previous treatments are mild or gone, except for hair loss or skin color changes.

I have previously been treated with immune checkpoint inhibitors.

+14 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

You have a condition that causes problems with blood clotting or excessive bleeding.

I do not have an active infection like TB, hepatitis B, or C.

+15 more

Participant Groups

The study compares combinations of durvalumab (an immunotherapy), olaparib (a PARP inhibitor), and cediranib (a drug blocking tumor growth) against standard treatments to see if they extend the time without cancer progression in patients with recurrent platinum-resistant ovarian-related cancers.

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm IV (cediranib maleate, olaparib)Experimental Treatment7 Interventions

Patients receive cediranib maleate PO QD on days 1-28 and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.

Group II: Arm III (durvalumab, cediranib maleate)Experimental Treatment8 Interventions

Patients receive durvalumab IV over 60 minutes on day 1 and cediranib maleate PO QD Monday through Friday. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.

Group III: Arm II (durvalumab, cediranib maleate, olaparib)Experimental Treatment9 Interventions

Patients receive durvalumab IV over 60 minutes on day 1, cediranib maleate PO QD Monday through Friday, and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.

Group IV: Arm I (paclitaxel, doxorubicin, topotecan hydrochloride))Active Control9 Interventions

Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15, or pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8 and 15 or days 1-5 per the discretion of the treating physician. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.