This is a pragmatic, non-inferiority randomized hybrid decentralized clinical trial. The goal of this study is to determine if one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab) is non-inferior to two years of maintenance therapy for patients with advanced/metastatic or recurrent endometrial cancer who have completed the standard course of cytotoxic chemotherapy plus anti-PD1 therapy (chemoimmunotherapy). Our hypothesis is that one year of maintenance therapy will be comparable, or statistically non-inferior, to two years of therapy. This question has clinical importance as there is not a clear optimal duration for maintenance immunotherapy in this setting, and checkpoint inhibitors are associated with their own unique toxicity profile (immune-related adverse events) and incremental costs to patients and the healthcare system at large. Patients who respond favorably to primary therapy and choose to enroll will be randomized (1:1) after completion of chemoimmunotherapy to one-year of maintenance anti-PD1 therapy (1-year arm) or to two-years of maintenance anti-PD1 therapy (2-year arm). The primary endpoint is progression-free survival (PFS) determined over the course of at least 3 years from randomization of patient follow up. Secondary endpoints are overall survival (OS) and incidence of immune-related adverse events (irAE). Finally, exploratory objectives include measuring differences in gut and vaginal microbial profiles and innate immune system (IIS) tumor profiles and correlation with clinical outcomes (PFS, OS).
Age ≥ 18 years at the time of consent.
Advanced stage (FIGO Stage III or IV) or recurrent EC.
Histological or cytological evidence/confirmation of any EC subtype, including carcinosarcoma.
Subject has completed standard of care carboplatin/taxol/anti-PD1 therapy (pembrolizumab or dostarlimab) with the plan for maintenance anti-PD-1 therapy.
Tumors with unknown mismatch repair protein status.
Receipt of additional anti-cancer agent(s) (e.g. bevacizumab, lenvatinib, progestins), other than cytotoxic chemotherapy received in combination with a PD-1 inhibitor at the beginning of the index treatment period (maintenance period).
Parallel
anti-PD1 agent therapy - 1 year
DrugOne year anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy
anti-PD1 agent therapy - 2 years
DrugTwo years anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy
Progression Free Survival
Progression Free Survival (PFS) is defined as the time from the date of randomization (at 1 year) to the first occurrence of disease progression (per RECIST 1.1 or comparable criteria) or death from any cause, whichever occurs first. Patients alive and progression-free at the end of study will be censored
Immune-Related Adverse Events (irAEs)
Immune-related adverse events (irAEs) are defined as adverse events considered by the investigator to be immune-mediated (e.g., colitis, pneumonitis, and dermatitis) and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The incidence of irAEs will be summarized by treatment arm.
Immune-Related Adverse Events (irAEs) Grade 3 or higher
Immune-related adverse events (irAEs) are defined as adverse events considered by the investigator to be immune-mediated (e.g., colitis, pneumonitis, and dermatitis) and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The incidence of Grade ≥3 irAEs between the 1-year and 2-year treatment-duration arms will be summarized by treatment arm.
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis or lost to follow-up will be censored at the date they were last known to be alive.
Disease-Specific Survival (DSS)
Disease-Specific Survival (DSS) is defined as time from randomization to death specifically attributed to endometrial cancer.
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