NCT07867002 · UNC Lineberger Comprehensive Cancer Center
Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer
(ASCEND-EC-DCT)
What this study is about
This is a pragmatic, non-inferiority randomly assigned 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 side effects) and incremental costs to patients and the healthcare system at large. Patients who respond favorably to primary therapy and choose to enroll will be randomly assigned (1:1) after completion of chemoimmunotherapy to one-year of maintenance anti-PD1 therapy (1-year treatment group$1) or to two-years of maintenance anti-PD1 therapy (2-year treatment group$1). The primary goal measurement is time without the disease getting worse (PFS) determined over the course of at least 3 years from randomization of patient follow up. Secondary endpoints are how long patients live (OS) and incidence of immune-related side effects (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).
View original scientific description
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).
Interventions
DRUG
anti-PD1 agent therapy - 1 year
One year anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy
DRUG
anti-PD1 agent therapy - 2 years
Two years anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy
Primary outcome measures
Progression Free Survival
Time frame: Up to 36 months
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Cary, North Carolina
- Chapel Hill, North Carolina
- Garner, North Carolina
- Greensboro, North Carolina
- Raleigh, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 5, 2026 · Source of record for eligibility and locations