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

NCT05715216 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2022-0896NCI-2023-008272021-0511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if adding etigilimab to nivolumab therapy can help to control clear cell ovarian, fallopian tube, and primary peritoneal cancers that are resistant to platinum-based therapy

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year.

Study Arms (1)

Etigilimab plus Nivolumab

EXPERIMENTAL

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).

Drug: Nivolumab; Drug: Etigilimab

Interventions

Nivolumab DRUG

Given by IV (vein)

Also known as: BMS-936558, Opdivo

Etigilimab plus Nivolumab

Etigilimab DRUG

Given by IV (vein)

Etigilimab plus Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide signed informed consent.
• Age ≥ 18 years at time of study entry.
• Willingness and ability to comply with the protocol for the duration of the study including undergoing treatment, biopsy, and scheduled visits and examinations including follow up.
• Histology showing recurrent clear cell ovarian, peritoneal, or fallopian tube cancer.
• Platinum resistant or refractory disease as defined by progression of disease on a platinum- containing regimen or recurrence of disease within 180 days of previous platinum treatment.
• Have measurable disease based on modified RECIST 1.1. For the purposes of this study measurable disease is defined at least one "target lesion" that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be \>20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>10 mm when measured by spiral CT. The target lesion must be distinct from other tumor areas selected for pre-treatment biopsies. Pre- treatment imaging must be performed within 4 weeks of starting therapy. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Adequate normal organ and marrow function as defined below.
• Hemoglobin ≥9.0 g/dL.
• Absolute neutrophil count (ANC) \> 1500/mm3.
• Platelet count ≥100 x 109/L (\>75,000/mm3).
• Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
• AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be
• x ULN.
• Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Creatinine CL (mL/min)
• Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL) 9. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients.
• Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:

You may not qualify if:

• Participation in another clinical study with an investigational product during the last 28 days.
• Prior treatment with CD137 agonists, anti-TIGIT antibody, anti-CTLA-4 or anti-PDL1/PD1 antibodies.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
• Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by study sponsors and the investigator.
• Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the primary investigator.
• Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with investigational therapy may be included only after consultation with the primary investigator.
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note:
• Local surgery of isolated lesions for palliative intent is acceptable.
• History of allogenic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criteria.
• a. Patients with vitiligo or alopecia. b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
• c. Any chronic skin condition that does not require systemic therapy. d. Patients without active disease in the last 5 years may be included but only after consultation with the primary investigator. e. Patients with celiac disease controlled by diet alone.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Mereo BioPharma: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shannon Westin, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: March 24, 2023
• Primary Completion: April 30, 2025
• Study Completion: February 8, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1)