Etigilimab + Nivolumab for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen byShannon N Westin

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing the combination of two drugs, etigilimab and nivolumab, in patients whose ovarian, peritoneal, or fallopian tube cancer has returned and does not respond to other treatments. These drugs help the immune system fight cancer and stop it from growing. The goal is to see if this combination can better control the cancer and understand its effects on the immune system.

Eligibility Criteria

This trial is for adults with recurrent clear cell ovarian, peritoneal, or fallopian tube cancer that's resistant to platinum-based therapy. Participants must have measurable disease, acceptable organ function tests, and an ECOG performance status of 0 or 1. Pregnant women and those not using birth control are excluded.

Inclusion Criteria

Your blood test shows that you have enough infection-fighting cells called neutrophils (ANC > 1500/mm^3) within 28 days of starting the study treatment.

Willingness and ability to comply with the protocol for the duration of the study

AST/ALT =< 2.5 x ULN or =< 5 x ULN if liver metastases are present (within 28 days of starting study treatment)

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Exclusion Criteria

You received a live vaccine in the past month before starting the trial.

You currently have a blockage in your small or large intestine that has not been treated.

You are currently receiving any type of medication for cancer treatment, such as chemotherapy, immunotherapy, biologic therapy, or hormone therapy.

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Treatment Details

Interventions

Etigilimab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe trial studies the effects of combining two immunotherapy drugs: Etigilimab and Nivolumab. It aims to see if this combination can help control cancer growth in patients whose disease has returned after platinum-based treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (etigilimab, nivolumab)Experimental Treatment2 Interventions

Patients receive etigilimab IV over 30-90 minutes on days 1 and 15 and nivolumab IV over 30 minutes on days 2 and 15 of cycle 1 and days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.