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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05715216
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Given by IV (vein)
  • Etigilimab — DRUG
    Given by IV (vein)

Study Details

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

Key Dates

Start date
Mar 24, 2023
Status verified
May 2025
Primary completion
Apr 30, 2025
Completion
Feb 8, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Etigilimab plus Nivolumab
    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).

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
M D Anderson Cancer Center· Houston, TX

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