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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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: Oct 2026to Oct 2032
Phase: Phase 3

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.

Emmie Cole contact

919-984-0000

emmie_cole@med.unc.edu

Erin Jennings contact

Erin_jennings@med.unc.edu

City, postcode or hospital

6 sites in 1 country

United States6 sites

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
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
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
Wesley Long Cone Health Cancer Center
Greensboro, North Carolina, 27403
Glenn P Boyles, 336-832-1100
Glenn Boyles
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
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

Other trials in United States

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 groups in NCT07867002
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.

Oct 2026Oct 2032

First posted9 Oct 2026
Study startOct 2026 (estimated)
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.
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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07867002
Sponsor's protocol ID: LCCC2507-DCT
Acronym: ASCEND-EC-DCT
Status last verified: Oct 2026
First submitted: 2 Oct 2026
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Emmie Cole

919-984-0000

emmie_cole@med.unc.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Endometrial Adenocarcinoma trials