One year vs two years of maintenance immunotherapy for endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, non-inferiority trial that compares one year of maintenance anti-PD-1 therapy to two years in patients who have finished standard chemo-immunotherapy for advanced or recurrent endometrial cancer. It uses a pragmatic, hybrid decentralized design to reflect real-world care and minimize additional visits. Eligible participants are adults with confirmed advanced or recurrent disease who completed prior therapy and consent to participate; they are randomized 1:1 to receive either one year or two years of maintenance therapy. The study focuses on balancing potential immune-related side effects and cost against the goal of preserving disease control. Results could inform how long patients should stay on maintenance checkpoint inhibitors after initial success.

Why it matters

Who can join: the full rules

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 it's running

• UNC Health Cancer Care, A Service of UNC Hospitals
  Cary, North Carolina, United States Recruiting
• UNC Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting
• UNC Health Cancer Care, a service of UNC Hospitals (Garner)
  Garner, North Carolina, United States Recruiting
• Wesley Long Cone Health Cancer Center
  Greensboro, North Carolina, United States Recruiting
• UNC Health Cancer Care, a service of UNC Hospitals (Raleigh)
  Raleigh, North Carolina, United States Recruiting
• UNC Health Cancer Care, a service of UNC Hospitals (Wakefield)
  Raleigh, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Olivia D Lara, MD, MS — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Emmie Cole
• Email: emmie_cole@med.unc.edu
• Phone: 919-984-0000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Personalized navigation to support rural and Black women with endometrial cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.