Etigilimab + Nivolumab for Ovarian Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Up to 24 months

20 Participants Needed

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.

Research Team

Shannon N Westin

Principal Investigator

M.D. Anderson Cancer Center

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)

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive etigilimab and nivolumab intravenously. Etigilimab is administered on days 1 and 15, and nivolumab on days 2 and 15 of cycle 1, then both on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for up to 24 months.

Up to 24 months

Bi-weekly visits for IV administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits at 30 and 90 days.

90 days

2 visits (in-person)

Treatment Details

Interventions

• Etigilimab
• Nivolumab

Trial Overview The 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

Group I: Treatment (etigilimab, nivolumab) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+