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Brief Title: 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
Official Title: 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
Study ID: NCT05063552
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Aarti Bhatia
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR