Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer
ASCEND-EC-DCT
1 other identifier
interventional
140
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2026
Longer than P75 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2026
CompletedFirst Submitted
Initial submission to the registry
October 2, 2026
CompletedFirst Posted
Study publicly available on registry
October 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2032
October 9, 2026
October 1, 2026
6 years
October 2, 2026
October 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 36 months
Secondary Outcomes (4)
Immune-Related Adverse Events (irAEs)
Up to 36 months
Immune-Related Adverse Events (irAEs) Grade 3 or higher
Up to 36 months
Overall Survival (OS)
Up to 36 months
Disease-Specific Survival (DSS)
Up to 36 months
Study Arms (2)
anti-PD1 maintenance therapy -1 year
EXPERIMENTALParticipants receive one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).
anti-PD1 maintenance therapy - 2 years
EXPERIMENTALParticipants receive two years of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
UNC Health Cancer Care, A Service of UNC Hospitals
Cary, North Carolina, 27518, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
UNC Health Cancer Care, a service of UNC Hospitals (Garner)
Garner, North Carolina, 27529, United States
Wesley Long Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
UNC Health Cancer Care, a service of UNC Hospitals (Raleigh)
Raleigh, North Carolina, 27607, United States
UNC Health Cancer Care, a service of UNC Hospitals (Wakefield)
Raleigh, North Carolina, 27614, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivia D Lara, MD, MS
UNC Lineberger Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2026
First Posted
October 9, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
October 1, 2032
Study Completion (Estimated)
October 1, 2032
Last Updated
October 9, 2026
Record last verified: 2026-10