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

Conditions

• Endometrial Adenocarcinoma
• Endometrial Cancer
• Metastatic Endometrial Cancer
• Recurrent Endometrial Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• anti-PD1 agent therapy - 1 year — DRUG
  One year anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy
• anti-PD1 agent therapy - 2 years — DRUG
  Two years anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy

Study Details

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).

Key Dates

First listed

Oct 9, 2026

Start date

Oct 31, 2026

Status verified

Oct 2026

Primary completion

Oct 31, 2032

Completion

Oct 31, 2032

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: anti-PD1 maintenance therapy -1 year
  Participants receive one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).
• Experimental: anti-PD1 maintenance therapy - 2 years
  Participants receive two years of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).

Primary Outcome Measure

Progression Free Survival [ Time Frame: Up to 36 months ]

Central Contacts

• Emmie Cole
  919-984-0000
  [email protected]
• Erin Jennings
  [email protected]

Locations (6)

Find similar trials in Cary, NC

Related Studies

• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado
• SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
  Recruiting · Massive Bio, Inc. · Birmingham, Alabama
• A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
  PHASE1/PHASE2 · Recruiting · Alliance Foundation Trials, LLC. · Oklahoma City, Oklahoma
• The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
  PHASE1/PHASE2 · Recruiting · PMV Pharmaceuticals, Inc · La Jolla, California