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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

14 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

600

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Japón
    • Saitama
      • Hidaka, Saitama, Japón, 350-1298
        • Saitama Medical University International Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: PF-08634404 plus Chemotherapy
PF-08634404 plus Chemotherapy, followed by PF-08634404 maintenance therapy
Biológico: PF-08634404
Solution for IV infusion
Droga: Standard of Care Chemotherapy
Solution for IV infusion
Comparador activo: Pembrolizumab plus Chemotherapy
Pembrolizumab plus Chemotherapy, followed by Pembrolizumab maintenance therapy
Droga: Standard of Care Chemotherapy
Solution for IV infusion
Biológico: Pembrolizumab
Solution for IV infusion
Otros nombres:
  • keytruda

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS) using RECIST v1.1 as assessed by Blinded Independent Central Review (BICR)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Colaboradores

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

Investigadores

  • Director de estudio: Pfizer CT.gov Call Center, Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

9 de octubre de 2026

Finalización primaria (Estimado)

1 de junio de 2029

Finalización del estudio (Estimado)

30 de enero de 2031

Fechas de registro del estudio

Enviado por primera vez

5 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • C6461018
  • 2026-525584-40-00 (Identificador de registro: CTIS (EU))
  • GOG-3145 (Otro identificador: APGOT)
  • ENGOT-en37 (Otro identificador: APGOT)
  • APGOT-EN6 (Otro identificador: APGOT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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