Ovarian CancerPhase 2NCT05715216
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
A Phase 2 study testing Nivolumab and Etigilimab in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Nivolumab and Etigilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 8 Feb 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria will be assessed within 28 days of starting study treatment:
- 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.
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- 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
- 5x 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:
- Women <50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post- menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 10. Has primary central nervous system (CNS) malignancy or known unrelated/active CNS metastases and/or carcinomatous meningitis.
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- Subjects with previously treated, asymptomatic brain metastases may participate provided they meet the following criteria: clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and are off steroids 14 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of study drug.
- Subjects with asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, and no lesion >1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
- Subjects with CNS symptoms should undergo a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable. However, subjects with spinal cord compression must be excluded.
Who cannot join
- Exclusion criteria will be assessed within 28 days of starting study treatment and is listed below.
- 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.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
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- 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.
- Patients with vitiligo or alopecia. b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
- 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.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- History of another primary malignancy except for the following histories.
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- History of leptomeningeal carcinomatosis.
- Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have a MRI (preferred) or CT each preferably with intravenous (IV) contrast of the brain prior to study entry.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of trial therapies. Listed below are the exceptions to this criterion.
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of Nivolumab/Etigilimab combination therapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Unresolved partial or complete small or large bowel obstruction.
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Primary Objectives:
- To estimate the objective response rate of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer.
- To evaluate the toxicity of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer.
Secondary Objectives:
- To determine PFS of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer.
- To estimate the disease control rate of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer.
- To investigate molecular and immunological changes associated with the combination of TIGIT and PD-1 inhibition; specifically to describe changes in T cell populations (including but not limited to CD3, CD8, CD4, FOXP3) and cell proliferation, as well as report changes in the proportion of macrophage phenotypes M1 and M2 (with phenotypic markers potentially including arginase1, CD11b, PDL-1, and CD206)
- To determine feasibility of interrogating the gut microbial signatures and dietary patterns in an ovarian cancer cohort.
- Identify components and determinants of the gut microbiome that could modulate toxicity or provide a signature of excellent or poor response to cancer immunotherapy.
- Conditions
- Ovarian Cancer
- Being tested
- Nivolumab, Etigilimab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-936558, Opdivo
Given by IV (vein)
EtigilimabDrug
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Nivolumab; Drug: Etigilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer.
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).
Measured: 39 months
The Toxicity of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer.
Measured: 39 months
Secondary outcomes (1)
Duration of Response of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer
Duration of Response is defined as time from first treatment to documented disease progression.
Measured: 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Oct 2021
- Primary completion30 Apr 2025
- Study completion8 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mereo BioPharma
- Responsible party
- Sponsor
- Investigators
- Shannon Westin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715216
- Sponsor's protocol ID
- 2022-0896
- Other IDs
- NCI-2023-00827, 2021-0511
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2023
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05715216
- Acronym / sponsor ID
- 2022-0896
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Mereo BioPharma
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 8 Feb 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary Objectives:
- To estimate the objective response rate of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer.
- To evaluate the toxicity of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer.
Secondary Objectives:
- To determine PFS of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer.
- To estimate the disease control rate of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer.
- To investigate molecular and immunological changes associated with the combination of TIGIT and PD-1 inhibition; specifically to describe changes in T cell populations (including but not limited to CD3, CD8, CD4, FOXP3) and cell proliferation, as well as report changes in the proportion of macrophage phenotypes M1 and M2 (with phenotypic markers potentially including arginase1, CD11b, PDL-1, and CD206)
- To determine feasibility of interrogating the gut microbial signatures and dietary patterns in an ovarian cancer cohort.
- Identify components and determinants of the gut microbiome that could modulate toxicity or provide a signature of excellent or poor response to cancer immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etigilimab plus Nivolumab | Experimental | Drug: Nivolumab, Drug: EtigilimabParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (34 listed)
- Exclusion criteria will be assessed within 28 days of starting study treatment and is listed below.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558, OpdivoGiven by IV (vein) | Drug | Etigilimab plus Nivolumab |
| EtigilimabGiven by IV (vein) | Drug | Etigilimab plus Nivolumab |
Primary outcome
Objective Response Rate of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer.
Time frame: 39 months
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).
The Toxicity of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer.
Time frame: 39 months
1 secondary outcome
Duration of Response of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer
Time frame: 39 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Westin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Etigilimab in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate of the Combination of Etigilimab and Nivolumab in Patients With Platinum Resistant Clear Cell Ovarian Cancer. (time frame: 39 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.