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NCT04751370 · ClinicalTrials.gov registry record · Phase 2
Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer
A Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 20
- Study locations
NCT04751370 is a Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 115-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT04751370, a Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, 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. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- RADIATION Radiation Therapy
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
California
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria - Santa Maria
Colorado
- Penrose-Saint Francis Healthcare - Colorado Springs
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
- AdventHealth Porter - Denver
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Alabama
- Mobile Infirmary Medical Center - Mobile
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-02-08 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04751370
The ClinicalTrials.gov registry entry for NCT04751370 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 115-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (73% 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 Stage III Rectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT04751370 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Alaska, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04751370 about?
NCT04751370 is a clinical study titled "Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer". This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ...
What is the current status of trial NCT04751370?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2022-02-08. Estimated completion is 2026-12-31.
What conditions does trial NCT04751370 study?
This clinical trial studies the following conditions: Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Locally Advanced Rectal Adenocarcinoma.
What interventions are being tested in trial NCT04751370?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04751370?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04751370 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.