A Phase II/III Trial of Chemotherapy + Cetuximab vs Chemotherapy + Bevacizumab vs Atezolizumab + Bevacizumab Following Progression on Immune Checkpoint Inhibition in Recurrent/Metastatic Head and Neck Cancers

Who is this study for? Patients with recurrent/metastatic head and neck cancers
Status: Active_not_recruiting
Location: See all (172) locations...
Intervention Type: Procedure, Drug, Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Patient must not have uncontrolled hypertension, a history of hypertensive crisis or hypertensive encephalopathy, or a history of grade 4 thromboembolism

• Patient must not have a history of coagulopathy or hemorrhagic disorders

• Patient must not have a history of thrombosis (e.g., pulmonary embolism or deep venous thrombosis) currently requiring therapeutic anticoagulation (prophylactic use of anticoagulation is allowed)

• Patient must not be receiving chronic daily treatment with aspirin (\> 325 mg/day) or non-steroidal anti-inflammatory agents (NSAID's) known to inhibit platelet function. The use of anti-platelet agents \[e.g., dipyridamole (Persatine), ticlopidine (Ticlid), clopidogrel (Plavix)\] is allowed only if patient is not receiving concurrent aspirin or NSAID's known to inhibit platelet function

• Patient must have PD-L1 expression \>= 1% by CPS in the tumor and/or immune cells

‣ NOTE: Enrolling centers should test for PD-L1 CPS preferably using the SP263 assay. Where this is not feasible, using their preferred Clinical Laboratory Improvement Act (CLIA)-certified or similar assay will be accepted. It is preferred for standard of care (SOC) PD-L1 assessments to be done on post-first line ICI samples if available, but SOC PD-L1 assessments on pre-ICI samples will be accepted for eligibility

• Patient must not have a severe infection within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Patients must not have active tuberculosis

• Patient must not have a history of non-infectious pneumonitis requiring steroids at doses greater than or equal to 10 mg per day of prednisone or the equivalent on first line immunotherapy

• Patient must not have a history of solid organ transplantation or stem-cell transplant

• Patient must not be on immunosuppressive medication within 7 days prior to randomization except for: intranasal, inhaled, or topical steroids, local steroid injection, systemic corticosteroids at doses less than or equal to 10 mg per day of prednisone or the equivalent, or steroids used as premedication for hypersensitivity reactions

• Patient must not have an active autoimmune disease that requires systemic treatment within 2 years prior to randomization. Patients who are receiving replacement therapy for adrenal or pituitary insufficiency will not be excluded

• Patient must not have had a severe hypersensitivity reaction to any of the drug components used on this protocol or to chimeric or humanized antibodies or fusion proteins

• Patient must not have received any live vaccine within 30 days prior to randomization and while participating in the study (and continue for 5 months after the last dose of atezolizumab on Arm C). Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and coronavirus disease 2019 (COVID-19) (Note: intranasal influenza vaccines, such as Flu-Mist \[registered trademark\] are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events

• Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.

‣ All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.

⁃ A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

• Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 2 months after the last dose of treatment for patients assigned to Arm A and for 6 months after the last dose of protocol treatment for patients assigned to Arms B or C.

‣ NOTE: Patients must also not breastfeed while on treatment and for 2 months after the last dose of treatment for patients assigned to Arm A and for 6 months after the last dose of treatment for patients assigned to Arms B or C

• Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

• Leukocytes \>= 3,000/mcL (must be obtained =\< 14 days prior to protocol randomization)

• Absolute neutrophil count (ANC) \>= 1,500/mcL (must be obtained =\< 14 days prior to protocol randomization)

• Platelets \>= 100,000/mcL (must be obtained =\< 14 days prior to protocol randomization)

• Hemoglobin (Hgb) \> 9 g/dL (must be obtained =\< 14 days prior to protocol randomization) (Note: Patient may be transfused to meet this criteria)

• Total bilirubin =\< 2.0 x institutional upper limit of normal (ULN) (=\< 5.0 x institutional ULN if hepatic metastases present or =\< 3 x ULN for patients with known Gilbert's disease) (must be obtained =\< 14 days prior to protocol randomization)

• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (\< 5.0 x institutional ULN if hepatic metastases present) (must be obtained =\< 14 days prior to protocol randomization)

• Alkaline phosphatase \< 2.5 x institutional ULN (\< 5.0 x institutional ULN if hepatic or bone metastases present) (must be obtained =\< 14 days prior to protocol randomization)

• Creatinine =\< 1.5 x institutional ULN (must be obtained =\< 14 days prior to protocol randomization)

• Patients with uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN) must have their calcium levels corrected prior to randomization

• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients must not have untreated brain metastases or leptomeningeal disease

• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

• Patients must not have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients may have indwelling catheters (e.g., PleurX \[registered trademark\])

• Patient must not have significant cardiovascular disease (such as New York Heart Association class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to randomization, or unstable arrhythmia or unstable angina at the time of randomization

• Patient must not receive any other chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy, or experimental medications while on protocol treatment. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization and patients must be recovered from the effects of radiation (there is no required minimum recovery period

• Patient must not have had a surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure while on protocol treatment

• Patient must not have any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the agents used in this protocol, may affect the interpretation of the results, or may render the patient at high risk from treatment complications

• Patient must not have a history of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
Little Rock
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
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
Smilow Cancer Hospital-Waterbury Care Center
Waterbury
Smilow Cancer Hospital Care Center - Waterford
Waterford
Washington, D.c.
MedStar Washington Hospital Center
Washington D.c.
Delaware
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach
Broward Health Medical Center
Fort Lauderdale
UM Sylvester Comprehensive Cancer Center at Kendall
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation
Georgia
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Hawaii
Hawaii Cancer Care - Westridge
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic - Ames
Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny
McFarland Clinic - Boone
Boone
Mercy Cancer Center-West Lakes
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive
Greater Regional Medical Center
Creston
Iowa Methodist Medical Center
Des Moines
Mercy Medical Center - Des Moines
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines
McFarland Clinic - Trinity Cancer Center
Fort Dodge
McFarland Clinic - Jefferson
Jefferson
McFarland Clinic - Marshalltown
Marshalltown
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee
Mercy Medical Center-West Lakes
West Des Moines
Idaho
Saint Luke's Cancer Institute - Boise
Boise
Kootenai Health - Coeur d'Alene
Coeur D'alene
Saint Luke's Cancer Institute - Fruitland
Fruitland
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Luke's Cancer Institute - Nampa
Nampa
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
Rush-Copley Medical Center
Aurora
Centralia Oncology Clinic
Centralia
John H Stroger Jr Hospital of Cook County
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
University of Illinois
Chicago
Carle at The Riverfront
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Ingalls Memorial Hospital
Harvey
Carle Physician Group-Mattoon/Charleston
Mattoon
UC Comprehensive Cancer Center at Silver Cross
New Lenox
Cancer Care Center of O'Fallon
O'fallon
HSHS Saint Elizabeth's Hospital
O'fallon
University of Chicago Medicine-Orland Park
Orland Park
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Springfield Memorial Hospital
Springfield
Carle Cancer Center
Urbana
Rush-Copley Healthcare Center
Yorkville
Louisiana
University Medical Center New Orleans
New Orleans
Massachusetts
UMass Memorial Medical Center - University Campus
Worcester
Maryland
Greater Baltimore Medical Center
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
University of Maryland/Greenebaum Cancer Center
Baltimore
UPMC Western Maryland
Cumberland
Minnesota
Mercy Hospital
Coon Rapids
Abbott-Northwestern Hospital
Minneapolis
Hennepin County Medical Center
Minneapolis
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
Missouri
Saint Francis Medical Center
Cape Girardeau
Mercy Hospital South
St Louis
Montana
Community Hospital of Anaconda
Anaconda
Billings Clinic Cancer Center
Billings
Bozeman Health Deaconess Hospital
Bozeman
Benefis Sletten Cancer Institute
Great Falls
Community Medical Center
Missoula
North Carolina
Southeastern Medical Oncology Center-Clinton
Clinton
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon
New Mexico
University of New Mexico Cancer Center
Albuquerque
Memorial Medical Center-Las Cruces
Las Cruces
Ohio
Miami Valley Hospital South
Centerville
Dayton Physician LLC - Englewood
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Premier Blood and Cancer Center
Dayton
Atrium Medical Center-Middletown Regional Hospital
Franklin
Miami Valley Cancer Care and Infusion
Greenville
Kettering Medical Center
Kettering
Trinity's Tony Teramana Cancer Center
Steubenville
Toledo Clinic Cancer Centers-Toledo
Toledo
Upper Valley Medical Center
Troy
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Providence Cancer Institute Clackamas Clinic
Clackamas
Providence Newberg Medical Center
Newberg
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Pennsylvania
UPMC Altoona
Altoona
UPMC-Heritage Valley Health System Beaver
Beaver
UPMC Hillman Cancer Center at Butler Health System
Butler
UPMC Camp Hill
Camp Hill
Carlisle Regional Cancer Center
Carlisle
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township
UPMC Hillman Cancer Center Erie
Erie
UPMC Cancer Center at UPMC Horizon
Farrell
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg
UPMC Hillman Cancer Center in Greenville/UPMC Horizon
Greenville
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg
IRMC Cancer Center
Indiana
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown
UPMC Cancer Center at UPMC McKeesport
Mckeesport
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg
Forbes Hospital
Monroeville
UPMC Hillman Cancer Center - Monroeville
Monroeville
UPMC Hillman Cancer Center in Coraopolis
Moon Township
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon
UPMC Cancer Center-Natrona Heights
Natrona Heights
UPMC Hillman Cancer Center - New Castle
New Castle
Jefferson Torresdale Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
Allegheny General Hospital
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
UPMC-Mercy Hospital
Pittsburgh
UPMC-Passavant Hospital
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh
UPMC-Saint Margaret
Pittsburgh
UPMC Cancer Center at UPMC Northwest
Seneca
UPMC Cancer Center-Uniontown
Uniontown
UPMC Cancer Center-Washington
Washington
UPMC West Mifflin-Cancer Center Jefferson
West Mifflin
Divine Providence Hospital
Williamsport
Asplundh Cancer Pavilion
Willow Grove
UPMC Memorial
York
Rhode Island
Smilow Cancer Hospital Care Center - Westerly
Westerly
South Dakota
Rapid City Regional Hospital
Rapid City
Tennessee
Thompson Cancer Survival Center
Knoxville
Thompson Cancer Survival Center - West
Knoxville
Thompson Oncology Group-Lenoir City
Lenoir City
Vanderbilt University/Ingram Cancer Center
Nashville
Thompson Oncology Group-Oak Ridge
Oak Ridge
Vermont
Dartmouth Cancer Center - North
Saint Johnsbury
Wisconsin
ProHealth D N Greenwald Center
Mukwonago
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
UW Cancer Center at ProHealth Care
Waukesha
West Virginia
West Virginia University Charleston Division
Charleston
Time Frame
Start Date: 2023-03-13
Completion Date: 2027-12-15
Participants
Target number of participants: 430
Treatments
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.
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov