Trial Outcomes & Findings for 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 (NCT NCT05715216)

Last Updated: 2026-07-08

Results Overview

Clinical benefit was defined as objective response or stable disease (SD) for greater than or equal to 4 months. Best overall response will be used for estimating Objective Response Rate, Complete Response (CR) + Partial Response (PR).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

39 months

Results posted on

2026-07-08

Participant Flow

The total recruitment time for this study was 51 months, from October 2021 to January 2025.

Participant milestones

Participant milestones
Measure	Nivolumab + Etigilimab Nivolumab 240 mg IV every 2 weeks + Etigilimab 20 mg/kg IV every 2 weeks for each 28 day cycle
Overall Study STARTED	23
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab + Etigilimab Nivolumab 240 mg IV every 2 weeks + Etigilimab 20 mg/kg IV every 2 weeks for each 28 day cycle
Overall Study Withdrawal by Subject	1
Overall Study Decline in performance status	2
Overall Study Early progression of disease	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab + Etigilimab n=23 Participants Nivolumab 240 mg IV every 2 weeks + Etigilimab 20 mg/kg IV every 2 weeks for each 28 day cycle
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=9 Participants
Age, Categorical >=65 years	2 Participants n=9 Participants
Age, Continuous	53.6 years n=9 Participants
Sex: Female, Male Female	23 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	3 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	2 Participants n=9 Participants
Race (NIH/OMB) White	17 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants
Region of Enrollment United States	23 participants n=9 Participants

PRIMARY outcome

Timeframe: 39 months

Population: Out of 23 participants, 19 were evaluable for response

Outcome measures

Outcome measures
Measure	Nivolumab + Etigilimab n=19 Participants Nivolumab 240 mg IV every 2 weeks + Etigilimab 20 mg/kg IV every 2 weeks for each 28 day cycle
Objective Response Rate of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer. Objective response rate	15 percentage of participants Interval 3.2 to 37.9
Objective Response Rate of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer. Clinical benefit rate	30 percentage of participants Interval 11.9 to 54.3

PRIMARY outcome

Timeframe: 39 months

Outcome measures

Outcome measures
Measure	Nivolumab + Etigilimab n=23 Participants Nivolumab 240 mg IV every 2 weeks + Etigilimab 20 mg/kg IV every 2 weeks for each 28 day cycle
The Toxicity of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer. Grade 3/4 adverse events	47.8 percentage of participants
The Toxicity of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer. DLTs	0 percentage of participants

SECONDARY outcome

Timeframe: 39 months

Duration of Response is defined as time from first treatment to documented disease progression.

Outcome measures

Outcome measures
Measure	Nivolumab + Etigilimab n=23 Participants Nivolumab 240 mg IV every 2 weeks + Etigilimab 20 mg/kg IV every 2 weeks for each 28 day cycle
Duration of Response of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer	8.6 months Interval 5.4 to 20.0

Adverse Events

Nivolumab + Etigilimab

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab + Etigilimab n=23 participants at risk Nivolumab 240 mg IV every 2 weeks + Etigilimab 20 mg/kg IV every 2 weeks for each 28 day cycle
Renal and urinary disorders Acute kidney injury	4.3% 1/23 • Number of events 1 • 39 months
Investigations Aspartate aminotransferase increased	21.7% 5/23 • Number of events 7 • 39 months
Investigations Alanine aminotransferase increased	21.7% 5/23 • Number of events 7 • 39 months
Investigations Alkaline phosphatase increased	8.7% 2/23 • Number of events 2 • 39 months
Investigations GGT increased	8.7% 2/23 • Number of events 2 • 39 months
Investigations Lipase increased	8.7% 2/23 • Number of events 3 • 39 months
Skin and subcutaneous tissue disorders Rash maculo-papular	4.3% 1/23 • Number of events 1 • 39 months

Other adverse events

Other adverse events
Measure	Nivolumab + Etigilimab n=23 participants at risk Nivolumab 240 mg IV every 2 weeks + Etigilimab 20 mg/kg IV every 2 weeks for each 28 day cycle
Investigations Thyroid stimulating hormone increased	13.0% 3/23 • Number of events 7 • 39 months
Gastrointestinal disorders Vomiting	21.7% 5/23 • Number of events 6 • 39 months
Investigations Weight loss	8.7% 2/23 • Number of events 2 • 39 months
Investigations White blood cell decreased	4.3% 1/23 • Number of events 1 • 39 months
Injury, poisoning and procedural complications Infusion related reaction	8.7% 2/23 • Number of events 2 • 39 months
Psychiatric disorders Insomnia	4.3% 1/23 • Number of events 1 • 39 months
Investigations Investigations - Other, Serum amylase decreased	4.3% 1/23 • Number of events 1 • 39 months
Investigations Lipase increased	26.1% 6/23 • Number of events 9 • 39 months
Investigations Lymphocyte count decreased	8.7% 2/23 • Number of events 2 • 39 months
Gastrointestinal disorders Mucositis oral	4.3% 1/23 • Number of events 1 • 39 months
Musculoskeletal and connective tissue disorders Myalgia	8.7% 2/23 • Number of events 2 • 39 months
Gastrointestinal disorders Nausea	26.1% 6/23 • Number of events 6 • 39 months
Cardiac disorders Palpitations	4.3% 1/23 • Number of events 1 • 39 months
Infections and infestations Papulopustular rash	8.7% 2/23 • Number of events 4 • 39 months
Nervous system disorders Paresthesia	4.3% 1/23 • Number of events 1 • 39 months
Reproductive system and breast disorders Pelvic pain	8.7% 2/23 • Number of events 2 • 39 months
Nervous system disorders Peripheral motor neuropathy	8.7% 2/23 • Number of events 2 • 39 months
Investigations Platelet count decreased	8.7% 2/23 • Number of events 2 • 39 months
Renal and urinary disorders Proteinuria	4.3% 1/23 • Number of events 1 • 39 months
Skin and subcutaneous tissue disorders Pruritus	30.4% 7/23 • Number of events 9 • 39 months
Skin and subcutaneous tissue disorders Rash maculo-papular	30.4% 7/23 • Number of events 10 • 39 months
Renal and urinary disorders Renal and urinary disorders - BUN increased	8.7% 2/23 • Number of events 3 • 39 months
Investigations Serum amylase increased	17.4% 4/23 • Number of events 5 • 39 months
Cardiac disorders Sinus tachycardia	4.3% 1/23 • Number of events 1 • 39 months
Infections and infestations Skin infection	4.3% 1/23 • Number of events 2 • 39 months
Gastrointestinal disorders Abdominal pain	13.0% 3/23 • Number of events 3 • 39 months
Endocrine disorders Adrenal insufficiency	8.7% 2/23 • Number of events 3 • 39 months
Investigations Alanine aminotransferase increased	47.8% 11/23 • Number of events 27 • 39 months
Investigations Alkaline phosphatase increased	21.7% 5/23 • Number of events 8 • 39 months
Blood and lymphatic system disorders Anemia	17.4% 4/23 • Number of events 7 • 39 months
Metabolism and nutrition disorders Anorexia	17.4% 4/23 • Number of events 4 • 39 months
Psychiatric disorders Anxiety	4.3% 1/23 • Number of events 1 • 39 months
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 2/23 • Number of events 2 • 39 months
Investigations Aspartate aminotransferase increased	52.2% 12/23 • Number of events 28 • 39 months
Immune system disorders Autoimmune disorder	4.3% 1/23 • Number of events 1 • 39 months
Musculoskeletal and connective tissue disorders Back pain	8.7% 2/23 • Number of events 2 • 39 months
Blood and lymphatic system disorders Blood and lymphatic - red blood count decreased	4.3% 1/23 • Number of events 1 • 39 months
Investigations Blood lactate dehydrogenase increased	4.3% 1/23 • Number of events 1 • 39 months
Investigations Blood bilirubin increased	4.3% 1/23 • Number of events 3 • 39 months
General disorders Chills	13.0% 3/23 • Number of events 3 • 39 months
Psychiatric disorders Confusion	4.3% 1/23 • Number of events 1 • 39 months
Investigations Creatinine increased	8.7% 2/23 • Number of events 2 • 39 months
Respiratory, thoracic and mediastinal disorders Cough	13.0% 3/23 • Number of events 3 • 39 months
Gastrointestinal disorders Diarrhea	8.7% 2/23 • Number of events 2 • 39 months
Gastrointestinal disorders Dry mouth	8.7% 2/23 • Number of events 2 • 39 months
Skin and subcutaneous tissue disorders Dry skin	4.3% 1/23 • Number of events 1 • 39 months
Nervous system disorders Dysgeusia	4.3% 1/23 • Number of events 2 • 39 months
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 1/23 • Number of events 1 • 39 months
General disorders Edema limbs	4.3% 1/23 • Number of events 1 • 39 months
Endocrine disorders Endocrine disorders - Cortisol increased	4.3% 1/23 • Number of events 1 • 39 months
Endocrine disorders Endocrine disorders - Cortisol decreased	4.3% 1/23 • Number of events 1 • 39 months
Skin and subcutaneous tissue disorders Erythema multiforme	4.3% 1/23 • Number of events 1 • 39 months
Infections and infestations Eye infection	4.3% 1/23 • Number of events 1 • 39 months
General disorders Fatigue	30.4% 7/23 • Number of events 8 • 39 months
General disorders Fever	4.3% 1/23 • Number of events 2 • 39 months
Gastrointestinal disorders Gastrointestinal disorders - gastroenteritis	4.3% 1/23 • Number of events 1 • 39 months
Investigations GGT increased	26.1% 6/23 • Number of events 12 • 39 months
Nervous system disorders Headache	8.7% 2/23 • Number of events 3 • 39 months
Hepatobiliary disorders Hepatic pain	4.3% 1/23 • Number of events 1 • 39 months
Metabolism and nutrition disorders Hypercalcemia	4.3% 1/23 • Number of events 1 • 39 months
Metabolism and nutrition disorders Hypoalbuminemia	8.7% 2/23 • Number of events 2 • 39 months
Metabolism and nutrition disorders Hypomagnesemia	13.0% 3/23 • Number of events 4 • 39 months
Metabolism and nutrition disorders Hyponatremia	26.1% 6/23 • Number of events 12 • 39 months
Metabolism and nutrition disorders Hypophosphatemia	4.3% 1/23 • Number of events 1 • 39 months
Endocrine disorders Hypothyroidism	4.3% 1/23 • Number of events 1 • 39 months

Additional Information

Shannon Westin, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 794-4314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place