Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Regeneron Pharmaceuticals
Registry number NCT03564340
Started 21 May 2018 Today 16 October 2026 Estimated completion 10 May 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Prince of Wales Hospital Randwick NSW Completed
Peter MacCallum Cancer Center Melbourne VIC Completed

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Female participants only
Healthy volunteers Not accepted
Enrolment target 890

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Key Inclusion Criteria:

1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:

1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)

2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)

3. documented relapse or progression on or after the most recent line of therapy

4. no standard therapy options likely to convey clinical benefit

2. Adequate organ and bone marrow function as defined in the protocol

3. Life expectancy of at least 3 months

4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.

5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:

1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol

2. 1-4 prior lines of systemic therapy, as described in the protocol

Key Exclusion Criteria:

1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol

2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)

3. Prior treatment with a MUC16 - targeted therapy

4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol

5. History and/or current cardiovascular disease, as defined in the protocol

6. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Dates on the record

Started 21 May 2018
Estimated completion 10 May 2027
Registry last updated 25 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 25 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.