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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

Study 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 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%
Chest pain
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Dry mouth
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Cardiac failure
2%
Sepsis
2%
Atrial fibrillation
2%
Embolism
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
1%
Pneumothorax
1%
Ileus
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion
1%
Femur fracture
1%
Pancytopenia
1%
Syncope
1%
Gastrointestinal haemorrhage
1%
Colitis
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Hypercalcaemia
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Superior vena cava syndrome
1%
Bronchial obstruction
1%
Performance status decreased
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
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
Etigilimab
2023
Completed Phase 2
~10
Nivolumab
2014
Completed Phase 3
~4750

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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,999 Previous Clinical Trials
1,794,071 Total Patients Enrolled
47 Trials studying Ovarian Cancer
16,735 Patients Enrolled for Ovarian Cancer
Shannon N WestinPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
1,176 Total Patients Enrolled

Media Library

Etigilimab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05026606 — Phase 2
Ovarian Cancer Research Study Groups: Treatment (etigilimab, nivolumab)
Ovarian Cancer Clinical Trial 2023: Etigilimab Highlights & Side Effects. Trial Name: NCT05026606 — Phase 2
Etigilimab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05026606 — Phase 2
~5 spots leftby Jun 2025