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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

RecruitingPhase 3Ages 18 Years - anyFemalePfizer
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In plain words

What the trial is, and whether it could suit you

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 c

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Women โ‰ฅ18 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.
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What it tests

  • PF-08634404
  • Pembrolizumab
  • Standard of Care Chemotherapy
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Where

54 sites
Jupiter Medical Center/ Anderson Family Cancer Institute
Jupiter, United States
Orlando Health Ambulatory Care Center
Orlando, United States
Orlando Health Cancer Institute
Orlando, United States
Orlando Health Orlando Regional Medical Center
Orlando, United States
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, United States
Minnesota Oncology Hematology, PA
Coon Rapids, United States
Minnesota Oncology Hematology, PA
Edina, United States
Minnesota Oncology Hematology, PA
Maple Grove, United States

โ€ฆand 46 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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