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 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: NCI-2021-10021EA3202U10CA180820
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 172

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS) (Phase II)

  Time from treatment initiation until disease progression or death, assessed up to 5 years from randomization

• Overall survival (OS) (Phase III)

  Will be compared using a stratified log rank test.

  Time from treatment initiation until death from any cause, assessed up to 5 years from randomization

Secondary Outcomes (4)

• OS in the subset of patients with high PD-L1 expression (Phase III)

  Up to 5 years from randomization

• Incidence of adverse events (Phase III)

  Up to 30 days after completion of treatment

• Correlation between fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and computed tomography (CT) neck imaging biomarkers

  Up to 5 years from randomization

• Prediction of treatment response

  Baseline up to 12 weeks

Other Outcomes (1)

• Correlation between 18F-FDG PET and CT neck radiomics features and expression of PD-L1 expression

  Up to 5 years from randomization

Study Arms (5)

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen Collection; Drug: Carboplatin; Biological: Cetuximab; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Docetaxel; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab)

EXPERIMENTAL

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.

Biological: Bevacizumab; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Docetaxel; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Phase II, Arm C (Bevacizumab, Atezolizumab)

EXPERIMENTAL

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.

Biological: Atezolizumab; Biological: Bevacizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Carboplatin; Biological: Cetuximab; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Docetaxel; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

EXPERIMENTAL

Patients receive treatment as in Arm B or C above based on results of the Phase II trial.

Biological: Atezolizumab; Biological: Bevacizumab; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Docetaxel; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Atezolizumab BIOLOGICAL

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq

Phase II, Arm C (Bevacizumab, Atezolizumab); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Bevacizumab BIOLOGICAL

Given IV

Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-aveg, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-byva, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-nwgd, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Jobevne, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev

Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase II, Arm C (Bevacizumab, Atezolizumab); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase II, Arm C (Bevacizumab, Atezolizumab); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin)

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Cetuximab BIOLOGICAL

Given IV

Also known as: C 225, C-225, C225, Cetuximab Biosimilar CDP-1, Cetuximab Biosimilar CMAB009, Cetuximab Biosimilar KL 140, Cetuximab-cetu, Chimeric Anti-EGFR Monoclonal Antibody, Chimeric MoAb C225, Chimeric Monoclonal Antibody C225, Erbitux, IMC-C225

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin)

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase II, Arm C (Bevacizumab, Atezolizumab); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Docetaxel DRUG

Given IV

Also known as: Docecad, RP 56976, RP-56976, RP56976, Taxotere, Taxotere Injection Concentrate

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Echocardiography Test PROCEDURE

Undergo ECHO

Also known as: EC, Echocardiography

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase II, Arm C (Bevacizumab, Atezolizumab); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase II, Arm C (Bevacizumab, Atezolizumab); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin); Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab); Phase II, Arm C (Bevacizumab, Atezolizumab); Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin); Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (excluding squamous cell carcinoma \[SCC\] of salivary glands, Epstein-Barr virus \[EBV\]-associated nasopharynx and skin)
• Patient must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Measurements must be obtained within 4 weeks prior to randomization
• Patient must be \>= 18 years of age
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patient must have disease progression after prior therapy with an immune checkpoint inhibitor (ICI) in the first-line setting for recurrent/metastatic disease. Patient must have received first-line immune checkpoint inhibition for at least 6 weeks. Patients who have recurred or progressed within 12 weeks of immune checkpoint inhibition administered in the definitive setting for locally advanced disease (for e.g., in the context of a clinical trial) will also be eligible if local therapies are not feasible
• Prior combination immunotherapies are permitted, but patient must not have had prior antiangiogenic treatment (e.g., bevacizumab, ziv-aflibercept, ramucirumab, sorafenib, sunitinib, pazopanib, regorafenib, lenvatinib, etc.). Patient must have completed any prior investigational therapy at least 28 days prior to randomization.
• NOTE: Patients who received platinum/taxanes in the locally-advanced or recurrent/metastatic setting and did not progress for at least 4 months thereafter, will be eligible for this study. Patients who received cetuximab in the locally-advanced setting and did not progress for at least 4 months thereafter, will also be eligible for this study
• Patient must not have a history of \>= grade 3 immune-related adverse event on prior ICI therapy (except those that could be managed with steroids \[e.g., dermatologic toxicity, asymptomatic elevation of pancreatic enzymes, etc.\]) and ICI could eventually be resumed. Patients who developed grade 3 endocrinopathies but are now stable on hormone supplementation and/or a daily prednisone dose of =\< 10 mg (or equivalent doses of another glucocorticoid), will be permitted on this trial
• Patient must not have a history of PD-1 inhibitor-induced hyper-progression, defined as 100% increase in tumor burden within 8 weeks (or 50% within 4 weeks) of initiating ICI and associated with clinical deterioration
• Patient must not have any of the following criteria due to the possibility of increased risk for tumor bleeding with bevacizumab therapy:
• Prior carotid bleeding,
• Tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies,
• Central (e.g., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies,
• Any prior history of bleeding related to the current head and neck cancer,
• History of gross hemoptysis (bright red blood of 1/2 teaspoon or more per episode of coughing) within 3 months prior to randomization

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (172)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Epic Care-Dublin

Dublin, California, 94568, United States

Location

Epic Care Partners in Cancer Care

Emeryville, California, 94608, United States

Location

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

Location

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

Location

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, 06033, United States

Location

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830, United States

Location

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital-Orange Care Center

Orange, Connecticut, 06477, United States

Location

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, 06902, United States

Location

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States

Location

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

Location

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

Location

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

Location

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States

Location

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States

Location

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States

Location

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

Location

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

Location

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States

Location

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

Location

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

Location

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States

Location

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States

Location

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Carle at The Riverfront

Danville, Illinois, 61832, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States

Location

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

Location

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

Location

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560, United States

Location

Mary Greeley Medical Center

Ames, Iowa, 50010, United States

Location

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

Location

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

Location

McFarland Clinic - Boone

Boone, Iowa, 50036, United States

Location

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States

Location

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States

Location

Greater Regional Medical Center

Creston, Iowa, 50801, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

Location

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501, United States

Location

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129, United States

Location

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158, United States

Location

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

Location

Mercy Medical Center-West Lakes

West Des Moines, Iowa, 50266, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

UPMC Western Maryland

Cumberland, Maryland, 21502, United States

Location

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Mercy Hospital South

St Louis, Missouri, 63128, United States

Location

Community Hospital of Anaconda

Anaconda, Montana, 59711, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Community Medical Center

Missoula, Montana, 59804, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Memorial Medical Center-Las Cruces

Las Cruces, New Mexico, 88011, United States

Location

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328, United States

Location

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546, United States

Location

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Premier Blood and Cancer Center

Dayton, Ohio, 45409, United States

Location

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415, United States

Location

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

Location

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Trinity's Tony Teramana Cancer Center

Steubenville, Ohio, 43952, United States

Location

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, 43623, United States

Location

Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015, United States

Location

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

UPMC Altoona

Altoona, Pennsylvania, 16601, United States

Location

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, 15009, United States

Location

UPMC Hillman Cancer Center at Butler Health System

Butler, Pennsylvania, 16001, United States

Location

UPMC Camp Hill

Camp Hill, Pennsylvania, 17011, United States

Location

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, 17015, United States

Location

UPMC Hillman Cancer Center - Passavant - Cranberry

Cranberry Township, Pennsylvania, 16066, United States

Location

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States

Location

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, 16121, United States

Location

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

Location

UPMC Hillman Cancer Center in Greenville/UPMC Horizon

Greenville, Pennsylvania, 16125, United States

Location

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109, United States

Location

IRMC Cancer Center

Indiana, Pennsylvania, 15701, United States

Location

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, 15901, United States

Location

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050, United States

Location

Forbes Hospital

Monroeville, Pennsylvania, 15146, United States

Location

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

UPMC Hillman Cancer Center in Coraopolis

Moon Township, Pennsylvania, 15108, United States

Location

UPMC Hillman Cancer Center - Part of Frick Hospital

Mount Pleasant, Pennsylvania, 15666, United States

Location

Arnold Palmer Cancer Center Medical Oncology Norwin

N. Huntingdon, Pennsylvania, 15642, United States

Location

UPMC Cancer Center-Natrona Heights

Natrona Heights, Pennsylvania, 15065, United States

Location

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, 16105, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC-Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243, United States

Location

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, 16346, United States

Location

UPMC Cancer Center-Uniontown

Uniontown, Pennsylvania, 15401, United States

Location

UPMC Cancer Center-Washington

Washington, Pennsylvania, 15301, United States

Location

UPMC West Mifflin-Cancer Center Jefferson

West Mifflin, Pennsylvania, 15122, United States

Location

Divine Providence Hospital

Williamsport, Pennsylvania, 17754, United States

Location

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

Location

UPMC Memorial

York, Pennsylvania, 17408, United States

Location

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island, 02891, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Covenant Health Cancer Centers

Knoxville, Tennessee, 37916, United States

Location

Covenant Health Cancer Centers - West

Knoxville, Tennessee, 37932, United States

Location

Covenant Health Oncology Group - Lenoir City

Lenoir City, Tennessee, 37772, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Covenant Health Oncology Group - Oak Ridge

Oak Ridge, Tennessee, 37830, United States

Location

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States

Location

West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States

Location

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

Location

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

Location

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Lymphoid Interstitial Pneumonia; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma

Interventions

atezolizumab; Bevacizumab; Immunoglobulin G; Disulfides; Specimen Handling; Carboplatin; Cetuximab; (225)Ac-DOTA-c(RGDyK); Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Docetaxel; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Coordination Complexes; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Aarti Bhatia

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 1, 2021
• Study Start: March 13, 2023
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (172)