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
Public ClinicalTrials.gov record NCT07578649. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AN INTERVENTIONAL PHASE 3, OPEN LABEL, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH ADVANCED OR RECURRENT MISMATCH REPAIR PROFICIENT ENDOMETRIAL CANCER
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 (with or without measurable disease) 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 to 2 years (35 cycles). Control Group will receive an approved medicine called pembrolizumab plus chemotherapy. It will be followed by pembrolizumab alone for up to 2 years (20 cycles). The study will include regular visits for: * Participants will have regular visits to the study site for treatment, health checks, and tests. * After stopping treatment, participants will come for a final visit within a month to check their health and review any reactions. * Follow-up will continue every 12 weeks by phone or in person or by reviewing health records. This helps check health and any new treatments. * Tests will be done every 9 weeks during the first 104 weeks to see how the cancer is responding. After that, tests will be done every 12 weeks.
Study identification
- NCT ID
- NCT07578649
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Interventions
- PF-08634404 Biological
- Pembrolizumab Biological
- Standard of Care Chemotherapy Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 9, 2026 (Estimated)
- Primary completion
- Jun 1, 2029 (Estimated)
- Completion
- Jan 30, 2031 (Estimated)
- Last update posted
- Sep 28, 2026
2026 – 2031
United States locations
- U.S. sites
- 36
- U.S. states
- 10
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Jupiter Medical Center/ Anderson Family Cancer Institute | Jupiter | Florida | 33458 | — |
| Minnesota Oncology Hematology, PA | Coon Rapids | Minnesota | 55433 | — |
| Minnesota Oncology Hematology, PA | Edina | Minnesota | 55435 | — |
| Minnesota Oncology Hematology, PA | Maple Grove | Minnesota | 55369 | — |
| Minnesota Oncology Hematology, PA | Maplewood | Minnesota | 55109 | — |
| Minnesota Oncology Hematology, PA | Woodbury | Minnesota | 55125 | — |
| The Center of Hope | Reno | Nevada | 89511 | — |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | — |
| Northwest Cancer Specialists, P.C. | Happy Valley | Oregon | 97015 | — |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | — |
| Northwest Cancer Specialists, P.C. | Tigard | Oregon | 97223 | — |
| Sarah Cannon Research Institute- Pharmacy | Nashville | Tennessee | 37203 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| Texas Oncology - West Texas | Abilene | Texas | 79606 | — |
| Texas Oncology-West Texas | Amarillo | Texas | 79124 | — |
| Texas Oncology - Central South | Austin | Texas | 78731 | — |
| Texas Oncology - Central South | Austin | Texas | 78745 | — |
| Texas Oncology - Central South | Austin | Texas | 78758 | — |
| Texas Oncology-West Texas | El Paso | Texas | 79902 | — |
| Texas Oncology - West Texas | El Paso | Texas | 79915 | — |
| Texas Oncology - West Texas | El Paso | Texas | 79938 | — |
| Texas Oncology - Central South | Harlingen | Texas | 78550 | — |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | — |
| Texas Oncology - Central South | McAllen | Texas | 78503 | — |
| Texas Oncology-West Texas | Midland | Texas | 79701 | — |
| Texas Oncology - West Texas | Odessa | Texas | 79761 | — |
| Texas Oncology - Central South | Waco | Texas | 76712 | — |
| Texas Oncology - Central South | Weslaco | Texas | 78596 | — |
| Texas Oncology-West Texas | Wichita Falls | Texas | 76310 | — |
| Virginia Oncology Associates | Chesapeake | Virginia | 23320 | — |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Virginia Oncology Associates | Suffolk | Virginia | 23435 | — |
| Virginia Oncology Associates | Williamsburg | Virginia | 23188 | — |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | — |
| Minnesota Oncology Hematology, P.A. | Hudson | Wisconsin | 54016 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07578649, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2026 · Synced Oct 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07578649 live on ClinicalTrials.gov.