Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

29. oktober 2026 oppdatert av: Pfizer

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

600

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Har ikke rekruttert ennå
        • GenesisCare - Campbelltown
    • Queensland
      • Toowoomba, Queensland, Australia, 4350
        • Har ikke rekruttert ennå
        • Toowoomba Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Har ikke rekruttert ennå
        • Bayside Health - Peninsula University Hospital
  • Forente stater
    • Florida
      • Jupiter, Florida, Forente stater, 33458
        • Rekruttering
        • Jupiter Medical Center/ Anderson Family Cancer Institute
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • Orlando Health Cancer Institute
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • Orlando Health Orlando Regional Medical Center
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • Orlando Health Winnie Palmer Hospital for Women & Babies
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • Orlando Health Ambulatory Care Center
    • Minnesota
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Rekruttering
        • Minnesota Oncology Hematology, PA
      • Edina, Minnesota, Forente stater, 55435
        • Rekruttering
        • Minnesota Oncology Hematology, PA
      • Maple Grove, Minnesota, Forente stater, 55369
        • Rekruttering
        • Minnesota Oncology Hematology, PA
      • Maplewood, Minnesota, Forente stater, 55109
        • Rekruttering
        • Minnesota Oncology Hematology, PA
      • Woodbury, Minnesota, Forente stater, 55125
        • Rekruttering
        • Minnesota Oncology Hematology, PA
    • Nevada
      • Reno, Nevada, Forente stater, 89511
        • Rekruttering
        • The Center of Hope
    • New York
      • Albany, New York, Forente stater, 12206
        • Har ikke rekruttert ennå
        • New York Oncology Hematology
      • White Plains, New York, Forente stater, 10601
        • Rekruttering
        • White Plains Hospital
    • Ohio
      • Centerville, Ohio, Forente stater, 45459
        • Rekruttering
        • Miami Valley Hospital South
    • Oregon
      • Happy Valley, Oregon, Forente stater, 97015
        • Rekruttering
        • Northwest Cancer Specialists, P.C.
      • Portland, Oregon, Forente stater, 97227
        • Rekruttering
        • Northwest Cancer Specialists, P.C.
      • Tigard, Oregon, Forente stater, 97223
        • Rekruttering
        • Northwest Cancer Specialists, P.C.
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • SCRI Oncology Partners
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • Sarah Cannon Research Institute- Pharmacy
    • Texas
      • Abilene, Texas, Forente stater, 79606
        • Rekruttering
        • Texas Oncology - West Texas
      • Amarillo, Texas, Forente stater, 79124
        • Rekruttering
        • Texas Oncology-West Texas
      • Austin, Texas, Forente stater, 78731
        • Rekruttering
        • Texas Oncology - Central South
      • Austin, Texas, Forente stater, 78758
        • Rekruttering
        • Texas Oncology - Central South
      • Austin, Texas, Forente stater, 78745
        • Rekruttering
        • Texas Oncology - Central South
      • El Paso, Texas, Forente stater, 79902
        • Rekruttering
        • Texas Oncology-West Texas
      • El Paso, Texas, Forente stater, 79915
        • Rekruttering
        • Texas Oncology - West Texas
      • El Paso, Texas, Forente stater, 79938
        • Rekruttering
        • Texas Oncology - West Texas
      • Harlingen, Texas, Forente stater, 78550
        • Rekruttering
        • Texas Oncology - Central South
      • Irving, Texas, Forente stater, 75063
        • Rekruttering
        • US Oncology Investigational Products Center (IPC)
      • McAllen, Texas, Forente stater, 78503
        • Rekruttering
        • Texas Oncology - Central South
      • Midland, Texas, Forente stater, 79701
        • Rekruttering
        • Texas Oncology-West Texas
      • Odessa, Texas, Forente stater, 79761
        • Rekruttering
        • Texas Oncology - West Texas
      • Waco, Texas, Forente stater, 76712
        • Rekruttering
        • Texas Oncology - Central South
      • Weslaco, Texas, Forente stater, 78596
        • Rekruttering
        • Texas Oncology - Central South
      • Wichita Falls, Texas, Forente stater, 76310
        • Rekruttering
        • Texas Oncology-West Texas
    • Virginia
      • Chesapeake, Virginia, Forente stater, 23320
        • Rekruttering
        • Virginia Oncology Associates
      • Newport News, Virginia, Forente stater, 23606
        • Rekruttering
        • Virginia Oncology Associates
      • Norfolk, Virginia, Forente stater, 23502
        • Rekruttering
        • Virginia Oncology Associates
      • Suffolk, Virginia, Forente stater, 23435
        • Rekruttering
        • Virginia Oncology Associates
      • Williamsburg, Virginia, Forente stater, 23188
        • Rekruttering
        • Virginia Oncology Associates
    • Washington
      • Vancouver, Washington, Forente stater, 98684
        • Rekruttering
        • Northwest Cancer Specialists, P.C.
    • Wisconsin
      • Hudson, Wisconsin, Forente stater, 54016
        • Rekruttering
        • Minnesota Oncology Hematology, P.A.
  • Japan
      • Fukushima, Japan, 960-1295
        • Rekruttering
        • Fukushima Medical University Hospital
      • Niigata, Japan, 951-8566
        • Rekruttering
        • Niigata Cancer Center Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0061
        • Rekruttering
        • Sapporo Medical University Hospital
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Rekruttering
        • Hyogo Cancer Center
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Har ikke rekruttert ennå
        • Saitama Medical University International Medical Center
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • Rekruttering
        • Cancer Institute Hospital of JFCR
  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Har ikke rekruttert ennå
        • Fudan University Shanghai Cancer Center
  • Taiwan
      • Taichung, Taiwan, 407
        • Rekruttering
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 404332
        • Har ikke rekruttert ennå
        • China Medical University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PF-08634404 plus Chemotherapy

PF-08634404 plus Chemotherapy, followed by PF-08634404 maintenance therapy
Biologisk: PF-08634404

Solution for IV infusion

Legemiddel: Standard of Care Chemotherapy

Solution for IV infusion
Aktiv komparator: Pembrolizumab plus Chemotherapy

Pembrolizumab plus Chemotherapy, followed by Pembrolizumab maintenance therapy
Legemiddel: Standard of Care Chemotherapy

Solution for IV infusion

Biologisk: Pembrolizumab

Solution for IV infusion

Andre navn:
  • keytruda

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS) using RECIST v1.1 as assessed by Blinded Independent Central Review (BICR)
Tidsramme: Approximately 36 months

PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1 as assessed by BICR, or death due to any cause, whichever occurs first.
Approximately 36 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Approximately 56 months

OS is defined as the time from the date of randomization to the date of death due to any cause.
Approximately 56 months
PFS using RECIST v1.1 as assessed by investigator
Tidsramme: Approximately 36 months

PFS by investigator is defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1 as assessed by investigator, or death due to any cause, whichever occurs first. PFS by investigator will be analyzed with the same methodology as for PFS by BICR.
Approximately 36 months
Objective Response Rate (ORR) as assessed by BICR and investigator
Tidsramme: Approximately 56 months

Proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1, assessed by BICR and by investigator
Approximately 56 months
Duration of Response (DoR) as assessed by BICR and investigator
Tidsramme: Approximately 56 months

Time from first documented CR or PR to disease progression or death, per RECIST v1.1, assessed by BICR and by investigator
Approximately 56 months
Number of participants with treatment-emergent adverse events
Tidsramme: Through end of the study and up to approximately 56 months

AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)
Through end of the study and up to approximately 56 months
Number of participants with laboratory abnormalities
Tidsramme: Through end of the study and up to approximately 56 months

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed.
Through end of the study and up to approximately 56 months
Serum concentrations of PF-08634404
Tidsramme: Through end of the study and up to approximately 56 months

Pre-dose and post-dose serum concentrations of PF-08634404
Through end of the study and up to approximately 56 months
Incidence of ADA against PF-08634404
Tidsramme: Through end of the study and up to approximately 56 months

Incidence of anti-drug antibodies (ADA) to PF-08634404
Through end of the study and up to approximately 56 months
Change from baseline in the global health status/quality of life (QoL) and physical functioning scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Tidsramme: Baseline, up to approximately 56 months

The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials. The core instrument is a 30-item questionnaire consisting of the following:

  • 5 Functional scales (physical, role, cognitive, emotional, social)
  • 3 Symptom scales (fatigue, pain, nausea, and vomiting, shortness of breath, loss of appetite, sleep disturbance, constipation, diarrhea) and financial impact of the disease
  • 2 Global items (global health status, overall HRQoL) All of the scales and single-item measures range in score from 0 to 100. High scale score represents a higher response level.
Baseline, up to approximately 56 months
Change from baseline in the back pain/pelvis pain, GI symptoms, and urological symptoms scales of the EORTC QLQ EN24
Tidsramme: Baseline, up to approximately 56 months

The Endometrial Cancer Module (EORTC QLQ-EN24) is a disease-specific measure that is supplemental to the EORTC QLQ-C30 to capture patient's experiences with endometrial cancer-specific symptoms and impacts. The recall period is the past week. The 24-item questionnaire consists of the following:

  • Symptom scales/items (Lymphoedema, urological symptoms, gastrointestinal symptoms, poor body image, and sexual/vaginal problems, pain in back and pelvis, tingling/numbness, muscular pain, hair loss, and taste change)
  • Functional scales (sexual interest, sexual activity, and sexual enjoyment)

Higher scores for functional scales represent high level of functioning, while higher scores for symptoms scales represent higher levels of symptoms/problems.
Baseline, up to approximately 56 months
Time to definitive deterioration in the global health status/QoL and physical functioning scale of the EORTC QLQ-C30.
Tidsramme: Approximately 56 months

The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30), is a validated 30-item self-administered core questionnaire designed to assess HRQoL, functioning, and symptoms in all cancer patients or survivors.

Time to deterioration is defined as time from baseline (defined as day 1 of cycle 1 before first application of maintenance therapy) to the date of the first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in:

  • Physical functioning score
  • Role functioning score
Approximately 56 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Samarbeidspartnere

GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

14. oktober 2026

Primær fullføring (Antatt)

1. juni 2029

Studiet fullført (Antatt)

30. januar 2031

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

11. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C6461018
  • 2026-525584-40-00 (Registeridentifikator: CTIS (EU))
  • GOG-3145 (Annen identifikator: APGOT)
  • ENGOT-en37 (Annen identifikator: APGOT)
  • APGOT-EN6 (Annen identifikator: APGOT)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere