What is the mechanism of action of this treatment?

Monoclonal antibodies like etigilimab and nivolumab work by enhancing the immune system's ability to fight ovarian cancer. Etigilimab targets TIGIT, a protein that suppresses immune responses, while nivolumab targets PD-1, a protein that inhibits T-cell activity. By blocking these proteins, these treatments can restore and boost the immune system's ability to attack cancer cells. This is crucial for ovarian cancer patients, especially those with platinum-resistant disease, as it provides a new treatment option when traditional chemotherapy is no longer effective.

What side effects are associated with this type of intervention?

Common side effects of treatments for ovarian cancer using monoclonal antibodies and immune checkpoint inhibitors, such as etigilimab and nivolumab, include immune-related adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe side effects are less frequent but can occur. Ocular side effects, including uveitis and autoimmune retinopathy, may also be observed.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of ovarian cancer, focusing on enhancing the immune response against cancer cells. Bevacizumab, an anti-VEGF antibody, is approved for use in combination with chemotherapy for advanced ovarian cancer. Additionally, pembrolizumab, a PD-1 inhibitor, has shown promise in treating ovarian cancer with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). These treatments, like etigilimab and nivolumab, aim to boost the body's immune system to target and destroy cancer cells.

What other types of research exist?

Promising alternatives to Etigilimab and Nivolumab for ovarian cancer patients include Pembrolizumab, Atezolizumab, and combination therapies such as Pembrolizumab with Lenvatinib. These therapies have shown efficacy in various cancers and are being explored for ovarian cancer treatment.

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Checkpoint Inhibitor

Etigilimab + Nivolumab for Ovarian Cancer

Phase 2

Waitlist Available

Led By Shannon N Westin

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, possible blood disorders like anemia or clotting issues, and increased risk of infections.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Objective response rate (ORR)

Secondary study objectives

Disease control rate (DCR)

Immunological changes

Median immune-related progression free survival (irPFS)

+1 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Etigilimab

2021

Completed Phase 2

~80

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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

Monoclonal antibodies like etigilimab and nivolumab work by enhancing the immune system's ability to fight ovarian cancer. Etigilimab targets TIGIT, a protein that suppresses immune responses, while nivolumab targets PD-1, a protein that inhibits T-cell activity. By blocking these proteins, these treatments can restore and boost the immune system's ability to attack cancer cells. This is crucial for ovarian cancer patients, especially those with platinum-resistant disease, as it provides a new treatment option when traditional chemotherapy is no longer effective.