Testen van het gebruik van geneesmiddelen voor onderzoek Atezolizumab en/of Bevacizumab met of zonder standaardchemotherapie bij de tweedelijnsbehandeling van hoofd-halskanker in een gevorderd stadium
Een fase II/III-studie van chemotherapie + cetuximab versus chemotherapie + bevacizumab versus atezolizumab + bevacizumab na progressie van immuuncheckpointremming bij recidiverende/gemetastaseerde hoofd- en halskankers
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.
Studie Overzicht
Toestand
Conditie
- Recidiverend plaveiselcelcarcinoom van het hoofd en de hals
- Recidiverend hypofarynx plaveiselcelcarcinoom
- Recidiverend larynx-plaveiselcelcarcinoom
- Gemetastaseerd hoofd-hals plaveiselcelcarcinoom
- Klinisch stadium IV HPV-gemedieerd (p16-positief) orofarynxcarcinoom AJCC v8
- Stadium IV hypofarynxcarcinoom AJCC v8
- Stadium IV larynxkanker AJCC v8
- Stadium IV Lip- en mondholtekanker AJCC v8
- Stadium IV orofaryngeaal (p16-negatief) carcinoom AJCC v8
- Gemetastaseerd hypofarynx plaveiselcelcarcinoom
- Gemetastaseerd larynx-plaveiselcelcarcinoom
- Gemetastaseerd lip- en mondholtecarcinoom
- Gemetastaseerd neusholte plaveiselcelcarcinoom
- Gemetastaseerd nasofaryngeaal plaveiselcelcarcinoom
- Gemetastaseerd farynx-plaveiselcelcarcinoom
- Gemetastaseerd sinonasaal plaveiselcelcarcinoom
- Recidiverende lip- en mondholte plaveiselcelcarcinoom
- Terugkerend nasofaryngeaal plaveiselcelcarcinoom
- Recidiverend farynxplaveiselcelcarcinoom
- Recidiverend sinonasaal plaveiselcelcarcinoom
- Stadium IV Nasofarynxcarcinoom AJCC v8
- Stadium IV Sinonasale kanker AJCC v8
- Stage IV hoofd en nek Cutane plaveiselcelcarcinoom AJCC V8
Interventie / Behandeling
- Geneesmiddel: Carboplatin
- Biologisch: Bevacizumab
- Geneesmiddel: Cisplatin
- Geneesmiddel: Docetaxel
- Procedure: Biospecimen Collection
- Procedure: Magnetic Resonance Imaging
- Procedure: Echocardiography Test
- Procedure: Computed Tomography
- Procedure: Positron Emission Tomography
- Biologisch: Atezolizumab
- Biologisch: Cetuximab
Gedetailleerde beschrijving
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 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.
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- University of Arkansas for Medical Sciences
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California
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Dublin, California, Verenigde Staten, 94568
- Epic Care-Dublin
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Emeryville, California, Verenigde Staten, 94608
- Epic Care Partners in Cancer Care
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Irvine, California, Verenigde Staten, 92612
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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Martinez, California, Verenigde Staten, 94553-3156
- Contra Costa Regional Medical Center
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Orange, California, Verenigde Staten, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Palo Alto, California, Verenigde Staten, 94304
- VA Palo Alto Health Care System
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Palo Alto, California, Verenigde Staten, 94304
- Stanford Cancer Institute Palo Alto
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Connecticut
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Derby, Connecticut, Verenigde Staten, 06418
- Smilow Cancer Hospital-Derby Care Center
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Fairfield, Connecticut, Verenigde Staten, 06824
- Smilow Cancer Hospital Care Center-Fairfield
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Glastonbury, Connecticut, Verenigde Staten, 06033
- Smilow Cancer Hospital Care Center at Glastonbury
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Greenwich, Connecticut, Verenigde Staten, 06830
- Smilow Cancer Hospital Care Center at Greenwich
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Guilford, Connecticut, Verenigde Staten, 06437
- Smilow Cancer Hospital Care Center - Guilford
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Hartford, Connecticut, Verenigde Staten, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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New Haven, Connecticut, Verenigde Staten, 06520
- Yale University
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North Haven, Connecticut, Verenigde Staten, 06473
- Yale-New Haven Hospital North Haven Medical Center
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Orange, Connecticut, Verenigde Staten, 06477
- Smilow Cancer Hospital-Orange Care Center
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Stamford, Connecticut, Verenigde Staten, 06902
- Smilow Cancer Hospital Care Center at Long Ridge
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Torrington, Connecticut, Verenigde Staten, 06790
- Smilow Cancer Hospital-Torrington Care Center
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Trumbull, Connecticut, Verenigde Staten, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Waterbury, Connecticut, Verenigde Staten, 06708
- Smilow Cancer Hospital-Waterbury Care Center
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Waterford, Connecticut, Verenigde Staten, 06385
- Smilow Cancer Hospital Care Center - Waterford
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Delaware
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Newark, Delaware, Verenigde Staten, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Verenigde Staten, 19713
- Medical Oncology Hematology Consultants PA
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20010
- MedStar Washington Hospital Center
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Florida
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Coral Gables, Florida, Verenigde Staten, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach, Florida, Verenigde Staten, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Fort Lauderdale, Florida, Verenigde Staten, 33316
- Broward Health Medical Center
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Miami, Florida, Verenigde Staten, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Verenigde Staten, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Verenigde Staten, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University Hospital/Winship Cancer Institute
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Verenigde Staten, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, Verenigde Staten, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, Verenigde Staten, 96817
- Queen's Cancer Center - Kuakini
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‘Aiea, Hawaii, Verenigde Staten, 96701
- Hawaii Cancer Care - Westridge
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Idaho
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Boise, Idaho, Verenigde Staten, 83712
- Saint Luke's Cancer Institute - Boise
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Coeur d'Alene, Idaho, Verenigde Staten, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Verenigde Staten, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Verenigde Staten, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Verenigde Staten, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Verenigde Staten, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Verenigde Staten, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Verenigde Staten, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Aurora, Illinois, Verenigde Staten, 60504
- Rush-Copley Medical Center
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Centralia, Illinois, Verenigde Staten, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Verenigde Staten, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- John H Stroger Jr Hospital of Cook County
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Danville, Illinois, Verenigde Staten, 61832
- Carle at The Riverfront
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Decatur, Illinois, Verenigde Staten, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Verenigde Staten, 62526
- Cancer Care Specialists of Illinois - Decatur
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Effingham, Illinois, Verenigde Staten, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Verenigde Staten, 62401
- Carle Physician Group-Effingham
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Harvey, Illinois, Verenigde Staten, 60426
- Ingalls Memorial Hospital
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Mattoon, Illinois, Verenigde Staten, 61938
- Carle Physician Group-Mattoon/Charleston
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New Lenox, Illinois, Verenigde Staten, 60451
- UC Comprehensive Cancer Center at Silver Cross
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O'Fallon, Illinois, Verenigde Staten, 62269
- Cancer Care Center of O'Fallon
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O'Fallon, Illinois, Verenigde Staten, 62269
- HSHS Saint Elizabeth's Hospital
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Orland Park, Illinois, Verenigde Staten, 60462
- University of Chicago Medicine-Orland Park
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Springfield, Illinois, Verenigde Staten, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Verenigde Staten, 62702
- Springfield Clinic
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Springfield, Illinois, Verenigde Staten, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Verenigde Staten, 61801
- Carle Cancer Center
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Yorkville, Illinois, Verenigde Staten, 60560
- Rush-Copley Healthcare Center
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Iowa
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Ames, Iowa, Verenigde Staten, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Verenigde Staten, 50010
- McFarland Clinic - Ames
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Ankeny, Iowa, Verenigde Staten, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Boone, Iowa, Verenigde Staten, 50036
- McFarland Clinic - Boone
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Clive, Iowa, Verenigde Staten, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Verenigde Staten, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Creston, Iowa, Verenigde Staten, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Verenigde Staten, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Verenigde Staten, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Verenigde Staten, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Verenigde Staten, 50158
- McFarland Clinic - Marshalltown
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Waukee, Iowa, Verenigde Staten, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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West Des Moines, Iowa, Verenigde Staten, 50266
- Mercy Medical Center-West Lakes
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- University Medical Center New Orleans
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, Verenigde Staten, 21204
- Greater Baltimore Medical Center
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Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland/Greenebaum Cancer Center
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Cumberland, Maryland, Verenigde Staten, 21502
- UPMC Western Maryland
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Massachusetts
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Worcester, Massachusetts, Verenigde Staten, 01655
- UMass Memorial Medical Center - University Campus
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Minnesota
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Coon Rapids, Minnesota, Verenigde Staten, 55433
- Mercy Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Verenigde Staten, 55101
- Regions Hospital
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Missouri
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Cape Girardeau, Missouri, Verenigde Staten, 63703
- Saint Francis Medical Center
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St Louis, Missouri, Verenigde Staten, 63128
- Mercy Hospital South
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Montana
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Anaconda, Montana, Verenigde Staten, 59711
- Community Hospital of Anaconda
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Billings, Montana, Verenigde Staten, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Verenigde Staten, 59405
- Benefis Sletten Cancer Institute
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Missoula, Montana, Verenigde Staten, 59804
- Community Medical Center
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87106
- University of New Mexico Cancer Center
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Las Cruces, New Mexico, Verenigde Staten, 88011
- Memorial Medical Center-Las Cruces
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North Carolina
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Clinton, North Carolina, Verenigde Staten, 28328
- Southeastern Medical Oncology Center-Clinton
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Goldsboro, North Carolina, Verenigde Staten, 27534
- Southeastern Medical Oncology Center-Goldsboro
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Jacksonville, North Carolina, Verenigde Staten, 28546
- Southeastern Medical Oncology Center-Jacksonville
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Ohio
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Centerville, Ohio, Verenigde Staten, 45459
- Miami Valley Hospital South
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Dayton, Ohio, Verenigde Staten, 45409
- Miami Valley Hospital
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Dayton, Ohio, Verenigde Staten, 45415
- Miami Valley Hospital North
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Dayton, Ohio, Verenigde Staten, 45415
- Dayton Physician LLC - Englewood
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Dayton, Ohio, Verenigde Staten, 45409
- Premier Blood and Cancer Center
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Franklin, Ohio, Verenigde Staten, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Verenigde Staten, 45331
- Miami Valley Cancer Care and Infusion
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Kettering, Ohio, Verenigde Staten, 45429
- Kettering Medical Center
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Steubenville, Ohio, Verenigde Staten, 43952
- Trinity's Tony Teramana Cancer Center
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Toledo, Ohio, Verenigde Staten, 43623
- Toledo Clinic Cancer Centers-Toledo
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Troy, Ohio, Verenigde Staten, 45373
- Upper Valley Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Clackamas, Oregon, Verenigde Staten, 97015
- Providence Cancer Institute Clackamas Clinic
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Newberg, Oregon, Verenigde Staten, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Verenigde Staten, 97213
- Providence Portland Medical Center
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Portland, Oregon, Verenigde Staten, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Altoona, Pennsylvania, Verenigde Staten, 16601
- UPMC Altoona
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Beaver, Pennsylvania, Verenigde Staten, 15009
- UPMC-Heritage Valley Health System Beaver
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Butler, Pennsylvania, Verenigde Staten, 16001
- UPMC Hillman Cancer Center at Butler Health System
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Camp Hill, Pennsylvania, Verenigde Staten, 17011
- UPMC Camp Hill
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Carlisle, Pennsylvania, Verenigde Staten, 17015
- Carlisle Regional Cancer Center
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Cranberry Township, Pennsylvania, Verenigde Staten, 16066
- UPMC Hillman Cancer Center - Passavant - Cranberry
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Erie, Pennsylvania, Verenigde Staten, 16505
- UPMC Hillman Cancer Center Erie
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Farrell, Pennsylvania, Verenigde Staten, 16121
- UPMC Cancer Center at UPMC Horizon
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Greensburg, Pennsylvania, Verenigde Staten, 15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
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Greenville, Pennsylvania, Verenigde Staten, 16125
- UPMC Hillman Cancer Center in Greenville/UPMC Horizon
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Harrisburg, Pennsylvania, Verenigde Staten, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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Indiana, Pennsylvania, Verenigde Staten, 15701
- IRMC Cancer Center
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Johnstown, Pennsylvania, Verenigde Staten, 15901
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
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McKeesport, Pennsylvania, Verenigde Staten, 15132
- UPMC Cancer Center at UPMC McKeesport
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Mechanicsburg, Pennsylvania, Verenigde Staten, 17050
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
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Monroeville, Pennsylvania, Verenigde Staten, 15146
- Forbes Hospital
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Monroeville, Pennsylvania, Verenigde Staten, 15146
- UPMC Hillman Cancer Center - Monroeville
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Moon Township, Pennsylvania, Verenigde Staten, 15108
- UPMC Hillman Cancer Center in Coraopolis
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Mount Pleasant, Pennsylvania, Verenigde Staten, 15666
- UPMC Hillman Cancer Center - Part of Frick Hospital
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N. Huntingdon, Pennsylvania, Verenigde Staten, 15642
- Arnold Palmer Cancer Center Medical Oncology Norwin
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Natrona Heights, Pennsylvania, Verenigde Staten, 15065
- UPMC Cancer Center-Natrona Heights
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New Castle, Pennsylvania, Verenigde Staten, 16105
- UPMC Hillman Cancer Center - New Castle
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Verenigde Staten, 19114
- Jefferson Torresdale Hospital
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Pittsburgh, Pennsylvania, Verenigde Staten, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Verenigde Staten, 15232
- UPMC Hillman Cancer Center
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Pittsburgh, Pennsylvania, Verenigde Staten, 15215
- UPMC-Saint Margaret
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Pittsburgh, Pennsylvania, Verenigde Staten, 15237
- UPMC-Passavant Hospital
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Pittsburgh, Pennsylvania, Verenigde Staten, 15243
- UPMC-Saint Clair Hospital Cancer Center
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Pittsburgh, Pennsylvania, Verenigde Staten, 15219
- UPMC-Mercy Hospital
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Seneca, Pennsylvania, Verenigde Staten, 16346
- UPMC Cancer Center at UPMC Northwest
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Uniontown, Pennsylvania, Verenigde Staten, 15401
- UPMC Cancer Center-Uniontown
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Washington, Pennsylvania, Verenigde Staten, 15301
- UPMC Cancer Center-Washington
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West Mifflin, Pennsylvania, Verenigde Staten, 15122
- UPMC West Mifflin-Cancer Center Jefferson
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Williamsport, Pennsylvania, Verenigde Staten, 17754
- Divine Providence Hospital
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Willow Grove, Pennsylvania, Verenigde Staten, 19090
- Asplundh Cancer Pavilion
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York, Pennsylvania, Verenigde Staten, 17408
- UPMC Memorial
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Rhode Island
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Westerly, Rhode Island, Verenigde Staten, 02891
- Smilow Cancer Hospital Care Center - Westerly
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South Dakota
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Rapid City, South Dakota, Verenigde Staten, 57701
- Rapid City Regional Hospital
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37916
- Covenant Health Cancer Centers
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Knoxville, Tennessee, Verenigde Staten, 37932
- Covenant Health Cancer Centers - West
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Lenoir City, Tennessee, Verenigde Staten, 37772
- Covenant Health Oncology Group - Lenoir City
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Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt University/Ingram Cancer Center
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Oak Ridge, Tennessee, Verenigde Staten, 37830
- Covenant Health Oncology Group - Oak Ridge
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Vermont
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Saint Johnsbury, Vermont, Verenigde Staten, 05819
- Dartmouth Cancer Center - North
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West Virginia
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Charleston, West Virginia, Verenigde Staten, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
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Wisconsin
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Mukwonago, Wisconsin, Verenigde Staten, 53149
- ProHealth D N Greenwald Center
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Oconomowoc, Wisconsin, Verenigde Staten, 53066
- ProHealth Oconomowoc Memorial Hospital
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Waukesha, Wisconsin, Verenigde Staten, 53188
- UW Cancer Center at ProHealth Care
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
-
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)
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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
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Patient must be >= 18 years of age
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Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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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
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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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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. |
Given IV
Andere namen:
Given IV
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Given IV
Andere namen:
Undergo blood sample collection
Andere namen:
Undergo MRI
Andere namen:
Undergo ECHO
Andere namen:
Undergo CT scan
Andere namen:
Undergo PET scan
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Given IV
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Experimenteel: 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. |
Given IV
Andere namen:
Given IV
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Given IV
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Given IV
Andere namen:
Undergo blood sample collection
Andere namen:
Undergo MRI
Andere namen:
Undergo ECHO
Andere namen:
Undergo CT scan
Andere namen:
Undergo PET scan
Andere namen:
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Experimenteel: 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. |
Given IV
Andere namen:
Undergo blood sample collection
Andere namen:
Undergo MRI
Andere namen:
Undergo ECHO
Andere namen:
Undergo CT scan
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Undergo PET scan
Andere namen:
Given IV
Andere namen:
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Experimenteel: 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. |
Given IV
Andere namen:
Given IV
Andere namen:
Given IV
Andere namen:
Undergo blood sample collection
Andere namen:
Undergo MRI
Andere namen:
Undergo ECHO
Andere namen:
Undergo CT scan
Andere namen:
Undergo PET scan
Andere namen:
Given IV
Andere namen:
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Experimenteel: 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. |
Given IV
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Given IV
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Given IV
Andere namen:
Undergo MRI
Andere namen:
Undergo ECHO
Andere namen:
Undergo CT scan
Andere namen:
Undergo PET scan
Andere namen:
Given IV
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progressievrije overleving (PFS) (fase II)
Tijdsspanne: Tijd vanaf het begin van de behandeling tot ziekteprogressie of overlijden, beoordeeld tot 5 jaar vanaf randomisatie
|
Tijd vanaf het begin van de behandeling tot ziekteprogressie of overlijden, beoordeeld tot 5 jaar vanaf randomisatie
|
|
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Overall survival (OS) (Phase III)
Tijdsspanne: Time from treatment initiation until death from any cause, assessed up to 5 years from randomization
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidentie van bijwerkingen (fase III)
Tijdsspanne: Tot 30 dagen na voltooiing van de behandeling
|
Tot 30 dagen na voltooiing van de behandeling
|
|
|
OS in the subset of patients with high PD-L1 expression (Phase III)
Tijdsspanne: Up to 5 years from randomization
|
The interaction of PD-L1 by treatment will also be evaluated in a Cox proportional hazards model. |
Up to 5 years from randomization
|
|
Correlation between fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and computed tomography (CT) neck imaging biomarkers
Tijdsspanne: Up to 5 years from randomization
|
The two-sample t-test will be used to compare the difference of baseline 18F -FDG PET /CT imaging biomarkers (maximum standardized uptake value [SUVmax], metabolic tumor volume [MTV], total lesion glycolysis [TLG], tumor volume) between low and high expression of PD-L1. |
Up to 5 years from randomization
|
|
Prediction of treatment response
Tijdsspanne: Baseline up to 12 weeks
|
Determined by 18FDG-PET/CT and CT neck imaging biomarkers. To determine if 18FDG-PET/CT and CT neck imaging biomarkers at baseline will predict treatment response at nine to twelve weeks post-treatment, PFS, and OS Logistic regression model will be fit to assess the association of the 18F -FDG PET /CT imaging biomarkers (e.g., SUVmax, MTV, TLG, tumor heterogeneity, tumor volume) with binary treatment response at 9-12 weeks post treatment. Cox proportional hazards models will be fit to assess the association of 18F -FDG PET /CT imaging biomarkers with time-to-event outcomes (PFS or OS). |
Baseline up to 12 weeks
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Correlation between 18F-FDG PET and CT neck radiomics features and expression of PD-L1 expression
Tijdsspanne: Up to 5 years from randomization
|
The imaging textural features from radiomics analysis will be associated with the dichotomized PD-L1 expressions. First, proper transformation will be applied to the textural features as needed to address the distribution skewness. Second, Pearson or Spearman rank correlations will be calculated between all pairs of textural features to identify highly correlated features. Third, to address overfitting and high collinearity, machine learning techniques (e.g., LASSO or XGBoost) will be employed for feature selection during the association analysis with PD-L1 expressions. |
Up to 5 years from randomization
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Aarti Bhatia, ECOG-ACRIN Cancer Research Group
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Mondziekten
- Stomatognatische ziekten
- Neoplasmata per site
- Neoplasmata
- Ziekten van de luchtwegen
- Neoplasmata per histologisch type
- Hoofd- en nekneoplasmata
- Neoplasmata, glandulair en epitheel
- Neoplasmata van de luchtwegen
- KNO-ziekten
- Faryngeale neoplasmata
- Otorinolaryngologische neoplasmata
- Nasofaryngeale ziekten
- Faryngeale ziekten
- Carcinoom, plaveiselcel
- Laryngeale ziekten
- Nasofaryngeale neoplasmata
- Nasofarynxcarcinoom
- Plaveiselcelcarcinoom van hoofd en hals
- Carcinoom
- Laryngeale neoplasmata
- Mond neoplasmata
- Orofaryngeale neoplasmata
- Hypofaryngeale neoplasmata
- Lymfoïde interstitiële pneumonie
- Aminozuren, peptiden en eiwitten
- Eiwitten
- Zwavelverbindingen
- Organische chemicaliën
- Onderzoekstechnieken
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Koolwaterstoffen
- Cycloparaffins
- Koolwaterstoffen, alicyclisch
- Koolwaterstoffen, cyclisch
- Terpenen
- Antilichamen, monoklonaal, gehumaniseerd
- Antilichamen, monoklonaal
- Antilichamen
- Immunoglobulinen
- Immunoproteïnen
- Bloedeiwitten
- Serum -globulines
- Globulines
- Anorganische chemicaliën
- Chloorverbindingen
- Stikstofverbindingen
- Coördinatiecomplexen
- Taxoids
- Cyclodecanes
- Diterpenen
- Elementen
- Metalen
- Chemie -technieken, analytisch
- Spectrumanalyse
- Metalen, zwaar
- Immunoglobuline -isotypes
- Sulfiden
- Anionen
- Ionen
- Elektrolyten
- Waterstofsulfide
- Platinumverbindingen
- Overgangselementen
- Docetaxel
- Bevacizumab
- Cetuximab
- Carboplatine
- Immunoglobuline G
- Cisplatine
- 1,2-diaminocyclohexaanplatina II-citraat
- Exemplaarbehandeling
- Magnetische resonantiespectroscopie
- Disulfides
- Platina
- atezolizumab
- (225) AC-DOTA-C (RGDYK)
Andere studie-ID-nummers
- NCI-2021-10021
- U10CA180820 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2021-10021 (Register-ID: CTRP (Clinical Trial Reporting Program))
- EA3202 (Andere identificatie: CTEP)
- EA3202 (Andere identificatie: ECOG-ACRIN Cancer Research Group)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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Informatie over medicijnen en apparaten, studiedocumenten
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