Endometrial AdenocarcinomaPhase 3ASCEND-EC-DCTNCT07867002
Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer
A Phase 3 study testing anti-PD1 agent therapy - 1 year and anti-PD1 agent therapy - 2 years in people with Endometrial Adenocarcinoma and Metastatic Endometrial Cancer, run by UNC Lineberger Comprehensive Cancer Center at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Adenocarcinoma, Metastatic Endometrial Cancer, Endometrial Cancer
- What is being tested?
- anti-PD1 agent therapy - 1 year and anti-PD1 agent therapy - 2 years
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Sep 2026to Oct 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Erin Jennings contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
UNC Health Cancer Care, A Service of UNC Hospitals
Cary, North Carolina, 27518
Emmie Cole, 919-962-7327, emmie_cole@med.unc.edu
Olivia D Lara, MD
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Emmie Cole, emmie_cole@med.unc.edu
Olivia D Lara, MD, MS
- Recruiting
UNC Health Cancer Care, a service of UNC Hospitals (Garner)
Garner, North Carolina, 27529
Emmie Cole, 919-962-7327, emmie_cole@med.unc.edu
Olivia D Lara, MD
- Recruiting
Wesley Long Cone Health Cancer Center
Greensboro, North Carolina, 27403
Glenn P Boyles, 336-832-1100
Glenn Boyles
- Recruiting
UNC Health Cancer Care, a service of UNC Hospitals (Raleigh)
Raleigh, North Carolina, 27607
Emmie Cole, 919-962-7327, emmie_cole@med.unc.edu
Olivia D Lara, MD
- Recruiting
UNC Health Cancer Care, a service of UNC Hospitals (Wakefield)
Raleigh, North Carolina, 27614
Emmie Cole, 919-962-7327, emmie_cole@med.unc.edu
Olivia D Lara, MD
About this study
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).
- Conditions
- Endometrial Adenocarcinoma, Metastatic Endometrial Cancer, Endometrial Cancer, Recurrent Endometrial Cancer
- Being tested
- anti-PD1 agent therapy - 1 year, anti-PD1 agent therapy - 2 years
- Keywords
- immunotherapy, maintenance immunotherapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-PD1 agent therapy - 1 yearDrug
One year anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy
anti-PD1 agent therapy - 2 yearsDrug
Two years anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy
| Study group | Role | What they receive |
|---|---|---|
| anti-PD1 maintenance therapy -1 year | Experimental | Participants receive one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab). Receives: Drug: anti-PD1 agent therapy - 1 year |
| anti-PD1 maintenance therapy - 2 years | Experimental | Participants receive two years of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab). Receives: Drug: anti-PD1 agent therapy - 2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 36 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start9 Sep 2026
- Primary completionOct 2032 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic non-inferiority randomized controlled hybrid decentralized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivia D Lara, MD, MS, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867002
- Sponsor's protocol ID
- LCCC2507-DCT
- Acronym
- ASCEND-EC-DCT
- Status last verified
- Nov 2026
- First submitted
- 2 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07867002
- Acronym / sponsor ID
- ASCEND-EC-DCT / LCCC2507-DCT
- Conditions
- Endometrial Adenocarcinoma, Metastatic Endometrial Cancer, Endometrial Cancer, Recurrent Endometrial Cancer
- Keywords
- immunotherapy, maintenance immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- Oct 2032 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pragmatic non-inferiority randomized controlled hybrid decentralized trial
| Arm | Type | Receives |
|---|---|---|
| anti-PD1 maintenance therapy -1 year | Experimental | Drug: anti-PD1 agent therapy - 1 yearParticipants receive one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab). |
| anti-PD1 maintenance therapy - 2 years | Experimental | Drug: anti-PD1 agent therapy - 2 yearsParticipants receive two years of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-PD1 agent therapy - 1 yearOne year anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy | Drug | anti-PD1 maintenance therapy -1 year |
| anti-PD1 agent therapy - 2 yearsTwo years anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy | Drug | anti-PD1 maintenance therapy - 2 years |
Primary outcome
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
4 secondary outcomes
Immune-Related Adverse Events (irAEs)
Time frame: Up to 36 months
Immune-Related Adverse Events (irAEs) Grade 3 or higher
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Disease-Specific Survival (DSS)
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Jennings contact
Olivia D Lara, MD, MS principal investigator
UNC Lineberger Comprehensive Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing anti-PD1 agent therapy - 1 year and anti-PD1 agent therapy - 2 years in people with Endometrial Adenocarcinoma and Metastatic Endometrial Cancer, run by UNC Lineberger Comprehensive Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmie Cole (919-984-0000, emmie_cole@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.