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NCT04214067 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer
A Phase 3 study of Endometrial Endometrioid Adenocarcinoma and Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 164
- Enrollment target
- 20
- Study locations
NCT04214067 is a Phase 3 study of Endometrial Endometrioid Adenocarcinoma and Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 164 participants, below the 255-participant average among 6 other Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT04214067, a Phase 3 study of Endometrial Endometrioid Adenocarcinoma and Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 164 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- RADIATION External Beam Radiation Therapy
- RADIATION Brachytherapy
Study Locations (20)
California
- Community Cancer Institute - Clovis
- University Oncology Associates - Clovis
- John Muir Medical Center-Concord - Concord
- UC San Diego Moores Cancer Center - La Jolla
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- UCSF Medical Center-Mission Bay - San Francisco
- John Muir Medical Center-Walnut Creek - Walnut Creek
Colorado
- UCHealth University of Colorado Hospital - Aurora
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
- UCHealth Memorial Hospital Central - Colorado Springs
- Memorial Hospital North - Colorado Springs
- AdventHealth Porter - Denver
- UCHealth Highlands Ranch Hospital - Highlands Ranch
- AdventHealth Littleton - Littleton
- AdventHealth Parker - Parker
Connecticut
- Danbury Hospital - Danbury
- Smilow Cancer Hospital-Derby Care Center - Derby
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2020-04-09 |
| Est. Completion | 2027-02-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04214067
The ClinicalTrials.gov registry entry for NCT04214067 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 255-participant average among 6 other Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (36% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Endometrial Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04214067 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04214067 about?
NCT04214067 is a clinical study titled "Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer". This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, su...
What is the current status of trial NCT04214067?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 164 participants. The study started on 2020-04-09. Estimated completion is 2027-02-05.
What conditions does trial NCT04214067 study?
This clinical trial studies the following conditions: Endometrial Endometrioid Adenocarcinoma, Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8.
What interventions are being tested in trial NCT04214067?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), External Beam Radiation Therapy (RADIATION), Brachytherapy (RADIATION).
Who is sponsoring clinical trial NCT04214067?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04214067 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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