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NCT05063552 · ClinicalTrials.gov registry record · Phase 2
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
A Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 430
- Enrollment target
- 20
- Study locations
NCT05063552 is a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 430 participants, above the 109-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (294% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT05063552, a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 430 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced stage) or has come back after prior treatment (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Cisplatin and carboplatin are in a class of chemotherapy medications known as platinum-containing compounds. They work by killing, stopping, or slowing the growth of cancer cells. Docetaxel is in a class of chemotherapy medications called taxanes. It stops cancer cells from growing and dividing and may kill them. The addition of bevacizumab to standard chemotherapy or combination therapy with bevacizumab and atezolizumab may be better than standard chemotherapy plus cetuximab in treating patients with recurrent/metastatic head and neck cancers.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Atezolizumab
- BIOLOGICAL Cetuximab
- BIOLOGICAL Bevacizumab
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital-Orange Care Center - Orange
- Smilow Cancer Hospital Care Center at Long Ridge - Stamford
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
California
- Epic Care-Dublin - Dublin
- Epic Care Partners in Cancer Care - Emeryville
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Contra Costa Regional Medical Center - Martinez
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Institute Palo Alto - Palo Alto
- VA Palo Alto Health Care System - Palo Alto
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2023-03-13 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05063552
The ClinicalTrials.gov registry entry for NCT05063552 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 109-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (294% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05063552 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Connecticut, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05063552 about?
NCT05063552 is a clinical study titled "Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers". This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced...
What is the current status of trial NCT05063552?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 430 participants. The study started on 2023-03-13. Estimated completion is 2027-12-15.
What conditions does trial NCT05063552 study?
This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05063552?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Atezolizumab (BIOLOGICAL), Cetuximab (BIOLOGICAL), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05063552?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05063552 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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