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

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.

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

My ovarian or related cancer has returned or worsened after initial treatments.

I have measurable cancer spread in my abdomen or behind it, according to specific criteria.

My kidney function, measured by creatinine clearance, is adequate.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

I haven't had a stroke, heart attack, or severe chest pain in the last 6 months.

I have a history of autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis.

I have an active infection in my abdomen.

I have cancer that has spread to my brain or surrounding membranes.

I have a chronic lung condition that needs steroids, oxygen, or has led to hospital stays.

I have previously received immune checkpoint inhibitor therapy.

I have low grade ovarian, fallopian tube, or peritoneal cancer.

Treatment Details

The 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.

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.

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

🇺🇸 Approved in United States as Yervoy for: