Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing anti-PD1 agent therapy - 1 year for Endometrial Adenocarcinoma

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).

Official registry: https://clinicaltrials.gov/study/NCT07867002 · UNC Lineberger Comprehensive Cancer Center · enrollment listed as 140

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are anti-PD1 agent therapy - 1 year, or anti-PD1 agent therapy - 2 years. The registry lists allocation as randomized. This is a pragmatic, non-inferiority randomly assigned hybrid decentralized clinical trial.

They plan to enroll about 140 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer

Interventions: anti-PD1 agent therapy - 1 year, anti-PD1 agent therapy - 2 years

Primary outcome (registry wording): Progression Free Survival

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • In order to participate in this study a subject must meet ALL of the eligibility criteria outlined below
  • 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

Public study contact (from the registry)

Emmie Cole

919-984-0000

emmie_cole@med.unc.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

6 listed

Related recruiting trials in this snapshot

RecruitingPhase 2Bethesda, Maryland
Phase 2: testing Pembrolizumab (Keytruda) for Metastatic Colorectal Cancer

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.

NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phasePhoenix, Arizona
Not a traditional drug phase: Vaginal Fluid Collection for Endometrial Cancer

The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma. This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid.

NCT05051722 · Official ClinicalTrials.gov record · Mayo Clinic

FAQ about this NCT record

Is NCT07867002 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07867002?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07867002?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary