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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination of etigilimab and nivolumab to determine its effectiveness in controlling certain types of ovarian, fallopian tube, and peritoneal cancers that have returned and resist standard platinum-based treatments. These drugs are a type of immunotherapy, helping the body’s immune system fight cancer. Suitable candidates for this trial have clear cell ovarian cancer, or similar cancers, that have not improved with previous platinum treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using etigilimab and nivolumab together is generally safe and well-tolerated. Studies have not identified any new safety issues with these treatments, meaning no unexpected side effects have emerged beyond what doctors already know.

Positive results in patients with other cancers, such as cervical cancer, suggest that this combination might be effective without causing significant harm. Researchers are testing the treatment to determine its effectiveness for ovarian cancer that doesn't respond to other treatments.

While all treatments can have side effects, existing research on this combination indicates it is quite manageable in terms of safety for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining etigilimab and nivolumab for ovarian cancer because this duo offers a novel approach. Unlike traditional treatments like chemotherapy, which attack cancer cells directly, this combination leverages the body's immune system. Etigilimab targets a protein called TIGIT, which often helps cancer cells hide from the immune system, while nivolumab blocks the PD-1 pathway, effectively releasing the brakes on immune cells. This dual action aims to enhance the immune response against cancer, offering hope for better outcomes.

What evidence suggests that etigilimab and nivolumab might be an effective treatment for ovarian cancer?

Research shows that using etigilimab and nivolumab together may help treat certain cancers. One study found that 25% of patients responded positively, with tumors either shrinking or not growing. The treatment proved safe, with no new safety issues. This trial will evaluate the combination of etigilimab and nivolumab for ovarian cancer. This combination has shown early success in treating other hard-to-treat cancers, such as cervical cancer, with some patients experiencing partial or complete disappearance of their cancer. These findings suggest that etigilimab and nivolumab might help control ovarian cancer that does not respond to platinum-based treatments. ^{1 2 3 4 5}

Who Is on the Research Team?

Shannon N Westin

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. mereobiopharma.com mereobiopharma.com/our-pipeline/etigilimab-mph313/

Etigilimab At the March 29, 2023, data cutoff, the objective response rate (ORR) was 25% in a total of 40 patients treated with the combination therapy including those ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.2651

Safety and efficacy of etigilimab in combination with ... Etig+nivo is safe and well tolerated with no new safety signals. Early efficacy was noted in cervical cancer (1CR, 1PR and 1SD) and uveal melanoma (3 SDs >20 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04761198

NCT04761198 | A Study of Etigilimab and Nivolumab in ... This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05026606

Study Details | NCT05026606 | EON: A Single-arm Phase II ... To estimate the objective response rate of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer. To ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/28/5/882/681700/A-Phase-1a-b-Open-Label-Dose-Escalation-Study-of

A Phase 1a/b Open-Label, Dose-Escalation Study of ... This study was designed to evaluate the safety, tolerability, and preliminary efficacy of etigilimab alone (Phase 1a) and in combination with the anti–PD-1 ...