A Phase 3 interventional study of anti-PD1 agent therapy - 1 year and anti-PD1 agent therapy - 2 years in Endometrial Adenocarcinoma, Metastatic Endometrial Cancer and Endometrial Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Not yet recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 3, Interventional, and Treatment
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).
1,347 studies on the registry are indexed under Endometrial Neoplasms; 452 are open to participants now.
This study's planned enrollment of 140 is above the median of 70 across 954 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 424 studies on the registry; 96 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
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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 willing and able to comply with study procedures based on the judgement of the investigator.
Exclusion Criteria:
Participants receive one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).
Drug: anti-PD1 agent therapy - 1 year
Participants receive two years of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).
Drug: anti-PD1 agent therapy - 2 years
One year anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy
Two 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
Time frame: Up to 36 months
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.
Time frame: Up to 36 months
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.
Time frame: Up to 36 months
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.
Time frame: Up to 36 months
Disease-Specific Survival (DSS)
Disease-Specific Survival (DSS) is defined as time from randomization to death specifically attributed to endometrial cancer.
Time frame: Up to 36 months
Start is estimated for Oct 2026; primary completion for Oct 2032, 72 months later.
Of 45 phase 3 interventional studies under Endometrial Neoplasms, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 126. This study's planned 72 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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