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NCT04671667 · ClinicalTrials.gov registry record · Phase 2
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma
A Phase 2 study of Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 188
- Enrollment target
- 20
- Study locations
NCT04671667 is a Phase 2 study of Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 188 participants, above the 113-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (66% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT04671667, a Phase 2 study of Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 188 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. 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. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Magnetic Resonance Imaging
- RADIATION Intensity-Modulated Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Bellflower - Bellflower
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Kaiser Permanente-Ontario - Ontario
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
- Sutter Roseville Medical Center - Roseville
- California Protons Cancer Therapy Center - San Diego
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital Care Center - Waterford - Waterford
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UF Health Cancer Institute - Gainesville - Gainesville
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04671667
The ClinicalTrials.gov registry entry for NCT04671667 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 113-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (66% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04671667 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT04671667 about?
NCT04671667 is a clinical study titled "Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma". This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head...
What is the current status of trial NCT04671667?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 188 participants. The study started on 2021-04-27. Estimated completion is 2029-06-30.
What conditions does trial NCT04671667 study?
This clinical trial studies the following conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04671667?
The interventions under investigation include: Carboplatin (DRUG), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Magnetic Resonance Imaging (PROCEDURE), Intensity-Modulated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04671667?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04671667 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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