Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING 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

NCT05063552 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 430 participants
Start Date 2023-03-13
Est. Completion 2027-12-15
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05063552 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05063552?

The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Atezolizumab (BIOLOGICAL), Cetuximab (BIOLOGICAL), Bevacizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05063552?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial