Phase 3 study for people with Endometrial Cancer

Not yet recruiting Phase 3

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

This trial at a glance

Status Not yet recruiting
Phase Phase 3
Sponsor Pfizer
Registry number NCT07578649
Started 9 October 2026 Today 16 October 2026 Estimated completion 1 June 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Bayside Health - Peninsula University Hospital Frankston VIC Status not stated

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 600

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:

* Women ≥18 years of age who are confirmed not pregnant at screening.

* Histologically or cytologically confirmed endometrial cancer that is recurrent or advanced; carcinosarcomas are eligible but pure sarcomas are excluded.

* Newly diagnosed FIGO Stage III disease with measurable disease per RECIST v1.1, newly diagnosed FIGO Stage IV disease with or without measurable disease, or recurrent disease with or without measurable disease for which curative treatment with surgery and/or radiotherapy is unlikely.

* For participants with recurrent disease, prior adjuvant systemic anti-cancer therapy is allowed if relapse occurred more than 6 months after the last dose.

* Must provide tumor tissue for prospective central assessment of MMR and p53 status.

* Proficient mismatch repair (pMMR) endometrial cancer as determined by central testing.

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

* Life expectancy of at least 12 weeks.

* Adequate organ function as defined in the protocol.

Exclusion Criteria:

* Prior systemic therapy for first-line advanced or recurrent endometrial cancer.

* Prior immunotherapy or anti-angiogenic therapy.

* Deficient mismatch repair (dMMR) endometrial cancer by central testing.

* Active or untreated central nervous system (CNS) metastases; participants with previously treated and clinically stable brain metastases may be eligible if not requiring steroids and without evidence of progression.

* Clinically significant risk of bleeding or fistula, including a history of severe bleeding disorders.

* History of another malignancy within 3 years, except for cancers with negligible risk of recurrence or death.

* History of allogeneic organ or hematopoietic stem cell transplantation; active autoimmune disease requiring systemic treatment within the past 2 years; or history of immunodeficiency

* Interstitial lung disease, pneumonitis, or clinically significant pulmonary disease

* Uncontrolled or significant cardiovascular, metabolic, renal, hepatic, or vascular disease

* Active or uncontrolled infection.

* Recent major surgery or severe trauma within protocol-defined washout periods.

Dates on the record

Started 9 October 2026
Estimated completion 1 June 2029
Registry last updated 8 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: 8 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.