← Back to Search

Checkpoint Inhibitor

Etigilimab + Nivolumab for Ovarian Cancer

Phase 2

Recruiting

Led By Shannon Westin, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histology showing recurrent clear cell ovarian, peritoneal, or fallopian tube cancer

Has primary central nervous system (CNS) malignancy or known unrelated/active CNS metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial tests if adding a drug to nivolumab can help fight resistant ovarian, fallopian tube and peritoneal cancers.

Who is the study for?

This trial is for adults with recurrent clear cell ovarian, peritoneal, or fallopian tube cancer that hasn't responded to platinum-based therapy. Participants must have good organ function and no major unresolved health issues. They can't have had recent cancer treatments, use immunosuppressive drugs, or have certain medical conditions that could affect the study's results.Check my eligibility

What is being tested?

The study tests if etigilimab combined with nivolumab can control advanced ovarian cancers resistant to standard treatments. It's a single-arm phase II trial where all participants receive both drugs to see how effective this combination is.See study design

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, digestive problems such as nausea or diarrhea, skin issues like rash or itching, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is a recurrent clear cell type in the ovary, peritoneum, or fallopian tube.

Select...

I do not have brain cancer or cancer spread to my brain or its coverings.

Select...

I am 18 years old or older.

Select...

My cancer got worse or came back within 6 months after platinum-based treatment.

Select...

I am post-menopausal or not pregnant if pre-menopausal.

Select...

I am willing and able to follow all study requirements, including treatments, biopsies, and visits.

Select...

I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

1Treatment groups

Experimental Treatment

Group I: Etigilimab plus NivolumabExperimental Treatment2 Interventions

Participants will receive the study drugs on Days 1 and 15 of each study cycle,Cycle 1, Participants will receive the drugs on separate days (etigilimab on Day 1 and nivolumab on Day 2). Starting with Cycle 2, you will receive both drugs on Day 1 (separated by 2 hours).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mereo BioPharmaIndustry Sponsor

22 Previous Clinical Trials

1,702 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,341 Total Patients Enrolled

46 Trials studying Ovarian Cancer

16,725 Patients Enrolled for Ovarian Cancer

Shannon Westin, MDPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

453 Total Patients Enrolled

2 Trials studying Ovarian Cancer

85 Patients Enrolled for Ovarian Cancer

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05715216 — Phase 2

Ovarian Cancer Research Study Groups: Etigilimab plus Nivolumab

Ovarian Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05715216 — Phase 2

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715216 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of Etigilimab and Nivolumab been sanctioned by the FDA?

"Due to the lack of efficacy data and presence of safety information, our team gave etigilimab plus nivolumab a score of 2 on its risk assessment scale."

Answered by AI

Is this research endeavor presently open to volunteers?

"According to the clinicaltrials.gov database, this particular study is not looking for volunteers at present; its initial posting was on July 31st 2023 and final edit occured on January 27th 2023. Nonetheless, there are 656 other studies presently recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer

2023. "EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05715216.