NCT07867002Not yet recruitingPhase 3
Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 2 Oct 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2032
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Endometrial cancer
- NCT number
- NCT07867002
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 140
- From Oct 2026 to the primary completion date, Oct 2032
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other
- Tumors with unknown mismatch repair protein status.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Health Cancer Care, A Service of UNC Hospitals Coordinator of this site? Confirm its status | Cary | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UNC Health Cancer Care, a service of UNC Hospitals (Garner) Coordinator of this site? Confirm its status | Garner | United States | Unknown status |
| Wesley Long Cone Health Cancer Center Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| UNC Health Cancer Care, a service of UNC Hospitals (Raleigh) Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| UNC Health Cancer Care, a service of UNC Hospitals (Wakefield) Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.