NCT07867002 Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer
| NCT ID | NCT07867002 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Endometrial Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-09-09 |
| Primary Completion | 2032-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 140 participants in total. It began in 2026-09-09 with a primary completion date of 2032-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion 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 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. Exclusion Criteria: * 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).
Contact & Investigator
Olivia D Lara, MD, MS
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07867002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endometrial Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07867002 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 140 participants.
Is NCT07867002 currently recruiting?
Yes, NCT07867002 is actively recruiting participants. Contact the research team at emmie_cole@med.unc.edu for enrollment information.
Where is the NCT07867002 trial being conducted?
This trial is being conducted at Cary, United States, Chapel Hill, United States, Garner, United States, Greensboro, United States and 2 additional locations.
Who is sponsoring the NCT07867002 clinical trial?
NCT07867002 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Olivia D Lara, MD, MS at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 140 participants.