Nivolumab +/- Ipilimumab for Advanced Gynecologic Cancers with Peritoneal Carcinomatosis

Recruiting in Palo Alto (17 mi)

Overseen byAmir A Jazaeri

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase Ib trial studies the side effects and best dose of nivolumab with or without ipilimumab in treating patients with female reproductive cancer that has come back (recurrent) or is high grade and has spread extensively throughout the peritoneal cavity (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Research Team

Amir A Jazaeri

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women with high-grade gynecologic cancers that have returned or spread, specifically ovarian, fallopian tube, peritoneal, endometrial, or cervical cancers. Participants must have tried standard treatments without success and meet certain health criteria like blood counts and organ function. Pregnant women or those with low-grade tumors, prior immunotherapy use, autoimmune diseases, recent heart issues or severe infections are excluded.

Inclusion Criteria

You have a platelet count of at least 100,000 per milliliter of blood.

Your total bilirubin level should be no higher than 1.5 times the upper limit of normal.

You have enough infection-fighting white blood cells in your body.

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Exclusion Criteria

I have had cancer before, but my doctor thinks it might not come back during the study.

I am currently hospitalized for an infection or another serious illness.

You have a health condition that the doctor thinks could make it unsafe for you to take the checkpoint inhibitor treatment.

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Treatment Details

Interventions

Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe study tests the safety and optimal doses of nivolumab alone or combined with ipilimumab in treating recurrent female reproductive cancers. These drugs are types of immunotherapy called monoclonal antibodies which may boost the immune system to fight cancer cells more effectively.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Group II (nivolumab and ipilimumab)Experimental Treatment4 Interventions

Patients receive nivolumab as in group I and ipilimumab i.p. on day 1. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Group I (nivolumab)Experimental Treatment3 Interventions

Patients receive nivolumab i.p. over 90 minutes on days 1, 15, and 29. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.