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Not yet recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07578649

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.

ClinicalTrials.gov public records Last synced Oct 2, 2026, 3:29 AM EDT

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
Lead sponsor
Pfizer
Industry
Enrollment
600 participants

Conditions and interventions

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.

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