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

Conditions

• Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Hypopharyngeal Squamous Cell Carcinoma
• Metastatic Laryngeal Squamous Cell Carcinoma
• Metastatic Lip and Oral Cavity Carcinoma
• Metastatic Nasal Cavity Squamous Cell Carcinoma
• Metastatic Nasopharyngeal Squamous Cell Carcinoma
• Metastatic Pharyngeal Squamous Cell Carcinoma
• Metastatic Sinonasal Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma
• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
• Recurrent Nasopharyngeal Squamous Cell Carcinoma
• Recurrent Pharyngeal Squamous Cell Carcinoma
• Recurrent Sinonasal Squamous Cell Carcinoma
• Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
• Stage IV Hypopharyngeal Carcinoma AJCC v8
• Stage IV Laryngeal Cancer AJCC v8
• Stage IV Lip and Oral Cavity Cancer AJCC v8
• Stage IV Nasopharyngeal Carcinoma AJCC v8
• Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IV Sinonasal Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — BIOLOGICAL
  Given IV
• Bevacizumab — BIOLOGICAL
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Carboplatin — DRUG
  Given IV
• Cetuximab — BIOLOGICAL
  Given IV
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Docetaxel — DRUG
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo PET scan

Study Details

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.

Key Dates

Start date

Mar 13, 2023

Status verified

Apr 2026

Primary completion

Dec 15, 2027

Completion

Dec 15, 2027

Study Design

Enrollment

430 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin)
  Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.
• Experimental: Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab)
  Patients receive bevacizumab IV over 30-90 minutes on day 1 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-60 minutes on day 1 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.
• Experimental: Phase II, Arm C (Bevacizumab, Atezolizumab)
  Patients receive bevacizumab IV over 30-90 minutes on day 1 and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.
• Experimental: Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin)
  Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.
• Experimental: Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)
  Patients receive treatment as in Arm B or C above based on results of the Phase II trial.

Primary Outcome Measure

Progression free survival (PFS) (Phase II) [ Time Frame: Time from treatment initiation until disease progression or death, assessed up to 5 years from randomization ]

Locations (172)

Find similar trials in Little Rock, AR

Related Studies

• Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
  PHASE2 · Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina
• 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
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
  PHASE1 · Recruiting · Ohio State University Comprehensive Cancer Center · Columbus, Ohio
• BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Phoenix, Arizona