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

Summary

This trial is testing the side effects and possible benefits of two immunotherapy drugs, etigilimab and nivolumab, in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back and is resistant to platinum-based therapy.

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.Check my eligibility

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.See study design

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

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

Primary outcome measures

Incidence of adverse events

Objective response rate (ORR)

Secondary outcome measures

Disease control rate (DCR)

Immunological changes

Median immune-related progression free survival (irPFS)

+1 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Neutropenia

21%

Pyrexia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Hypothyroidism

Abdominal pain upper

Upper respiratory tract infection

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hypertension

Bronchitis

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Hyperkalaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Dry mouth

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Myocardial infarction

Metastases to central nervous system

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Embolism

Cardiac failure

Malignant pleural effusion

Sepsis

Atrial fibrillation

General physical health deterioration

Adrenal insufficiency

Neoplasm progression

Cancer pain

Confusional state

Circulatory collapse

Bronchial obstruction

Pneumothorax

Atrial flutter

Ileus

Bone pain

Small intestinal haemorrhage

Pericardial effusion

Femur fracture

Pancytopenia

Colitis

Small intestinal obstruction

Hypercalcaemia

Syncope

Pericardial effusion malignant

Superior vena cava syndrome

Gastrointestinal haemorrhage

Lung cancer metastatic

Performance status decreased

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

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

2014

Completed Phase 3

~4740

Do I qualify?Apply below to find out

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.