What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, particularly those involving immune checkpoint inhibitors like Nivolumab, can lead to immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy, another common treatment, often results in side effects including nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Combining these treatments, as in the trial with Etigilimab and Nivolumab, may result in a combination of these side effects, necessitating close monitoring and management.

What prior FDA approvals exist?

Nivolumab, a PD-1 inhibitor, has been approved by the FDA for various cancers, including ovarian cancer, as part of immunotherapy regimens. These drugs work by enhancing the body's immune response against cancer cells. While TIGIT inhibitors like Etigilimab are still under investigation and not yet FDA-approved for ovarian cancer, they represent a promising area of research in combination with existing immunotherapies like Nivolumab.

What other types of research exist?

Promising alternatives to Etigilimab and Nivolumab for ovarian cancer patients include pembrolizumab combined with lenvatinib, which has shown improved progression-free survival and overall survival in endometrial cancer, and avelumab, a PD-L1 inhibitor, which has demonstrated durable responses in mesothelioma. Additionally, novel agents like utomilumab, a 4-1BB/CD137 agonist, in combination with pembrolizumab, have shown safety and clinical activity in advanced solid tumors and may be worth exploring.

← 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

Must not have

Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus

Current or prior use of immunosuppressive medication within 14 days before the first dose of trial therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, etigilimab and nivolumab, to help patients with certain types of cancer that don't respond to standard treatments. The drugs work by boosting the immune system's ability to attack cancer cells.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have active infections like TB, hepatitis B, C, or HIV.

Select...

I have not taken immunosuppressive medication in the last 14 days.

Select...

I have had cancer before, but it was a different type.

Select...

I currently have a blockage in my intestines.

Select...

I do not have any unmanaged ongoing illnesses.

Select...

I have not had major surgery within the last 28 days.

Select...

I have previously been treated with specific immune therapies.

Select...

I have received an organ transplant from another person.

Select...

I have or had an autoimmune or inflammatory disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Etigilimab

2021

Completed Phase 2

~80

Nivolumab

2015

Completed Phase 3

~4010

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while targeted therapy focuses on specific molecules involved in cancer growth. Immunotherapy, such as the combination of Etigilimab (a TIGIT inhibitor) and Nivolumab (a PD-1 inhibitor), enhances the immune system's ability to recognize and destroy cancer cells. Etigilimab blocks the TIGIT receptor, and Nivolumab inhibits the PD-1 pathway, both preventing cancer cells from evading immune detection. This is particularly important for ovarian cancer patients with platinum-resistant disease, as these therapies offer new avenues for treatment by leveraging the body's own immune system.