Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer

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

Trial Details

NCT ID
NCT07867002
Phase
PHASE3
Sponsor
UNC Lineberger Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • anti-PD1 agent therapy - 1 year
  • anti-PD1 agent therapy - 2 years
Locations (sample)
  • Cary, North Carolina, United States|35.79154,-78.78112
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584
  • Garner, North Carolina, United States|35.71126,-78.61417
  • Greensboro, North Carolina, United States|36.07264,-79.79198
  • Raleigh, North Carolina, United States|35.7721,-78.63861

Key Eligibility Criteria

  • In order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.
  • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subject is willin…
  • Age ≥ 18 years at the time of consent.
  • Advanced stage (FIGO Stage III or IV) or recurrent EC.

For full eligibility, visit ClinicalTrials.gov.

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