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Spots Global Cancer Trial Database for 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

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Study Description

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.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate progression-free survival (PFS) of patients treated with chemotherapy plus cetuximab, chemotherapy plus bevacizumab, and atezolizumab plus bevacizumab. (Phase II) II. To evaluate the overall survival (OS) of patients treated with chemotherapy plus cetuximab to the superior arm from the phase II portion of the protocol. (Phase III) SECONDARY OBJECTIVES: I. To evaluate the OS for the subset of patients with high PD-L1 expression, defined as combined positive score (CPS) \>= 20% on all arms of treatment. II. To evaluate the toxicity of each arm of treatment. IMAGING OBJECTIVES: I. To establish the correlation between fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and computed tomography (CT) neck imaging biomarkers (maximum standard uptake value \[SUVmax\], metabolic tumor volume \[MTV\], total lesion glycolysis \[TLG\], tumor volume) and expression of PD-L1 expression (Low versus high, defined as CPS \< 20 versus CPS \>= 20). II. To determine if 18FDG-PET/CT and CT neck imaging biomarkers at baseline will predict treatment response at nine to twelve weeks post the initiation of treatment, PFS, and OS. EXPLORATORY OBJECTIVE: I. To establish the correlation between 18F-FDG PET and CT neck radiomics features and PD-L1 expressions (Low versus high - defined as CPS \< 20 versus CPS \>= 20). OUTLINE: This is a randomized phase II trial followed by a randomized phase III trial. PHASE II: Patients are randomized to 1 of 3 arms. ARM A: Patients receive cetuximab intravenously (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 magnetic resonance imaging (MRI) throughout the trial. Patients may undergo echocardiography (ECHO) during screening. ARM B: 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. ARM C: Patients receive bevacizumab IV over 30-90 minutes on day 1 and atezolizumab 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. PHASE III: Patients are randomized to 1 of 2 arms. ARM A: 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. ARM B: Patients receive treatment as in Arm B or C above based on results of the Phase II trial. Patients undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days and then every 3 months if patient is \< 2 years from randomization and every 6 months if patient is 2-5 years from randomization.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Epic Care-Dublin, Dublin, California, United States

Epic Care Partners in Cancer Care, Emeryville, California, United States

Contra Costa Regional Medical Center, Martinez, California, United States

Stanford Cancer Institute Palo Alto, Palo Alto, California, United States

VA Palo Alto Health Care System, Palo Alto, California, United States

Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, United States

Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury, Connecticut, United States

Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford, Guilford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, United States

Smilow Cancer Hospital-Orange Care Center, Orange, Connecticut, United States

Smilow Cancer Hospital Care Center at Long Ridge, Stamford, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, United States

Helen F Graham Cancer Center, Newark, Delaware, United States

Medical Oncology Hematology Consultants PA, Newark, Delaware, United States

MedStar Washington Hospital Center, Washington, District of Columbia, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

Broward Health Medical Center, Fort Lauderdale, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall, Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States

Emory University Hospital Midtown, Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Hawaii Cancer Care - Westridge, 'Aiea, Hawaii, United States

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States

Queen's Medical Center, Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States

Rush - Copley Medical Center, Aurora, Illinois, United States

John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States

University of Illinois, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Carle at The Riverfront, Danville, Illinois, United States

Carle Physician Group-Effingham, Effingham, Illinois, United States

Ingalls Memorial Hospital, Harvey, Illinois, United States

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

Rush-Copley Healthcare Center, Yorkville, Illinois, United States

Mary Greeley Medical Center, Ames, Iowa, United States

McFarland Clinic - Ames, Ames, Iowa, United States

Mission Cancer and Blood - Ankeny, Ankeny, Iowa, United States

McFarland Clinic - Boone, Boone, Iowa, United States

Mercy Cancer Center-West Lakes, Clive, Iowa, United States

Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States

Greater Regional Medical Center, Creston, Iowa, United States

Iowa Methodist Medical Center, Des Moines, Iowa, United States

Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States

Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

Mission Cancer and Blood - Laurel, Des Moines, Iowa, United States

McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson, Jefferson, Iowa, United States

McFarland Clinic - Marshalltown, Marshalltown, Iowa, United States

Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

Greater Baltimore Medical Center, Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

UPMC Western Maryland, Cumberland, Maryland, United States

UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, United States

Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States

Miami Valley Hospital South, Centerville, Ohio, United States

Miami Valley Hospital, Dayton, Ohio, United States

Premier Blood and Cancer Center, Dayton, Ohio, United States

Dayton Physician LLC - Englewood, Dayton, Ohio, United States

Miami Valley Hospital North, Dayton, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States

Miami Valley Cancer Care and Infusion, Greenville, Ohio, United States

Kettering Medical Center, Kettering, Ohio, United States

Trinity's Tony Teramana Cancer Center, Steubenville, Ohio, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States

Upper Valley Medical Center, Troy, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States

Providence Newberg Medical Center, Newberg, Oregon, United States

Providence Portland Medical Center, Portland, Oregon, United States

Providence Saint Vincent Medical Center, Portland, Oregon, United States

UPMC Altoona, Altoona, Pennsylvania, United States

UPMC-Heritage Valley Health System Beaver, Beaver, Pennsylvania, United States

UPMC Hillman Cancer Center at Butler Health System, Butler, Pennsylvania, United States

UPMC Camp Hill, Camp Hill, Pennsylvania, United States

Carlisle Regional Cancer Center, Carlisle, Pennsylvania, United States

UPMC Hillman Cancer Center - Passavant - Cranberry, Cranberry Township, Pennsylvania, United States

UPMC Hillman Cancer Center Erie, Erie, Pennsylvania, United States

UPMC Cancer Center at UPMC Horizon, Farrell, Pennsylvania, United States

UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States

Oncology Hematology Associates, Greenville, Pennsylvania, United States

UPMC Hillman Cancer Center in Greenville/UPMC Horizon, Greenville, Pennsylvania, United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg, Pennsylvania, United States

IRMC Cancer Center, Indiana, Pennsylvania, United States

UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown, Pennsylvania, United States

UPMC Cancer Center at UPMC McKeesport, McKeesport, Pennsylvania, United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg, Pennsylvania, United States

Forbes Hospital, Monroeville, Pennsylvania, United States

UPMC Hillman Cancer Center - Monroeville, Monroeville, Pennsylvania, United States

UPMC Hillman Cancer Center in Coraopolis, Moon, Pennsylvania, United States

UPMC Hillman Cancer Center - Part of Frick Hospital, Mount Pleasant, Pennsylvania, United States

Arnold Palmer Cancer Center Medical Oncology Norwin, N. Huntingdon, Pennsylvania, United States

UPMC Cancer Center-Natrona Heights, Natrona Heights, Pennsylvania, United States

UPMC Hillman Cancer Center - New Castle, New Castle, Pennsylvania, United States

ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

Jefferson Torresdale Hospital, Philadelphia, Pennsylvania, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

UPMC-Saint Margaret, Pittsburgh, Pennsylvania, United States

UPMC-Mercy Hospital, Pittsburgh, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, United States

UPMC-Saint Clair Hospital Cancer Center, Pittsburgh, Pennsylvania, United States

UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, United States

UPMC Cancer Center-Uniontown, Uniontown, Pennsylvania, United States

UPMC Cancer Center-Washington, Washington, Pennsylvania, United States

UPMC West Mifflin-Cancer Center Jefferson, West Mifflin, Pennsylvania, United States

Divine Providence Hospital, Williamsport, Pennsylvania, United States

Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States

UPMC Memorial, York, Pennsylvania, United States

Smilow Cancer Hospital Care Center - Westerly, Westerly, Rhode Island, United States

Thompson Cancer Survival Center, Knoxville, Tennessee, United States

Thompson Cancer Survival Center - West, Knoxville, Tennessee, United States

Thompson Oncology Group-Lenoir City, Lenoir City, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Thompson Oncology Group-Oak Ridge, Oak Ridge, Tennessee, United States

Dartmouth Cancer Center - North, Saint Johnsbury, Vermont, United States

West Virginia University Charleston Division, Charleston, West Virginia, United States

ProHealth D N Greenwald Center, Mukwonago, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States

UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States

Contact Details

Name: Aarti Bhatia

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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