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NCT07578649 · ClinicalTrials.gov registry record · Phase 3
Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer
A Phase 3 study, sponsored by Pfizer.
- Not yet
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
NCT07578649 is a Phase 3 study that has not yet begun recruiting, run by Pfizer. The registered enrollment target is 600 participants.
The verdict
NCT07578649, a Phase 3 study, has not yet begun recruiting, sponsored by Pfizer.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
Study Summary
This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy. Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. Our bodies have a built-in DNA "spell-checker," called the mismatch repair (MMR) system, that fixes genetic mistakes. In most endometrial cancers, this system works normally, and these cancers are called MMR-proficient (pMMR). However, pMMR tumors are harder for the immune system to recognize and attack. When endometrial cancer has spread beyond the uterus or comes back after previous treatment, it is called advanced or recurrent endometrial cancer. This study is for adults with mismatch repair-pMMR advanced or recurrent endometrial cancer. Participants must meet key criteria, including: * Women who are 18 years or older, and not pregnant at the time of joining the study * pMMR endometrial cancer only * Measurable Stage III disease, Stage IV disease (with or without measurable disease) per FIGO staging, a system doctors use to describe how far cancer has spread in the body, or recurrent endometrial cancer * Has not received chemotherapy except for chemotherapy given after the main surgery and more than 6 months before relapse * Be in good enough health to receive study treatment. Approximately 600 adult women will be enrolled. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups, with about half in each group. The study is open, meaning both the doctors and participants know what treatment is being given. Participants will receive their assigned treatment through intravenous infusions (medicine is given directly into a vein). The treatment will be given in cycles. Experimental Group will receive new study medicine called PF-08634404 plus chemotherapy. It will be followed by PF 08634404 alone for up
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL PF-08634404
- DRUG Standard of Care Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2026-10-09 |
| Est. Completion | 2031-01-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07578649
The ClinicalTrials.gov registry entry for NCT07578649 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT07578649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07578649 about?
NCT07578649 is a clinical study titled "Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer". This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy. Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or s...
What is the current status of trial NCT07578649?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2026-10-09. Estimated completion is 2031-01-30.
What interventions are being tested in trial NCT07578649?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), PF-08634404 (BIOLOGICAL), Standard of Care Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT07578649?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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