Phase 3 study for people with Ovarian Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Merck Sharp & Dohme LLC
Registry number NCT06824467
Started 9 April 2025 Today 16 October 2026 Estimated completion 27 April 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Blacktown Hospital ( Site 0211) Sydney NSW Recruiting
Gallipoli Medical Research Ltd ( Site 0214) Brisbane QLD Recruiting
Epworth Freemasons ( Site 0217) East Melbourne VIC Recruiting
Frankston Hospital ( Site 0216) Frankston VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Female participants only
Healthy volunteers Not accepted
Enrolment target 770

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.

Inclusion Criteria:

* Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies

* Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)

* Has platinum-sensitive epithelial OC

* Has provided tissue of a tumor lesion that was not previously irradiated

* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy

* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)

* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

* Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)

Exclusion Criteria:

* Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma

* Has platinum-resistant OC or platinum-refractory OC

* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing

* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)

* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease

* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening

* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

* Has received more than 2 prior lines of systemic therapy for OC

* Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)

* Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids

* Has an additional malignancy that is progressing or has required active treatment within the past 3 years

* Has active central nervous system (CNS) metastases and/or carcinomatous meningitis

* Has an active infection requiring systemic therapy

* Has active or ongoing stomatitis

Dates on the record

Started 9 April 2025
Estimated completion 27 April 2029
Registry last updated 13 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 13 October 2026.
  • This page last checked by Voxsanity: 15 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.