TITRE |
(EN) A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting |
PROTOCOLE ID |
KEYNOTE-C93 (GOG-3064/ENGOT-en15) |
CLINICAL TRIAL.gov ID |
NCT05173987 |
TYPE(S) DE CANCER |
Endomètre |
PHASE |
Phase III |
TYPE D'ÉTUDE |
Clinique |
INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
VILLE |
Montréal
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Christine Lambert Lucy Gilbert
|
COORDONATEUR(RICE) |
Phuong-Nam (Nathalie) Nguyen phuong-nam.nguyen@mail.mcgill.ca 514-934-1934 poste 31975
|
STATUT |
Fermé
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN) The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
|
CRITÈRES D'EXCLUSION |
(EN)
- Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed
- Has EC of any histology that is proficient mismatch repair (pMMR)
- Is a candidate for curative-intent surgery or curative-intent radiotherapy
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
- Has received prior systemic anticancer therapy including investigational agents for EC. This includes any chemotherapy given for EC other than as a radiosensitizer
- Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded
- Has known active CNS metastases and/or carcinomatous meningitis
- Has a known intolerance to any study intervention and/or any of its excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection, requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has had an allogenic tissue/solid organ transplant
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