Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer
Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)
3 other identifiers
interventional
60
1 country
428
Brief Summary
This phase II trial studies how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2019
Longer than P75 for phase_2
428 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 10, 2019
CompletedStudy Start
First participant enrolled
June 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedFebruary 5, 2026
February 1, 2026
5.7 years
May 8, 2019
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Prolonging of progression free survival (PFS) on avelumab and cetuximab compared to avelumab alone
The study will be declared promising if, after the 37th PFS event, the hazard ratio is less than 0.758.
Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment
Secondary Outcomes (5)
Confirmed objective response rate (RR)
Up to 2 years post treatment
Clinical benefit rate (CBR)
Up to 2 years post treatment
PFS in patients who have progressed on avelumab alone
From time of enrollment to documented progression (or death), assessed up to 2 years
Overall Survival (OS)
Time between enrollment and or death, assessed up to 2 years post treatment
Incidence of adverse events
Up to 30 days post treatment
Study Arms (2)
Arm I (Avelumab)
ACTIVE COMPARATORPatients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.
Arm II (Avelumab, cetuximab)
EXPERIMENTALPatients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- PRE-REGISTRATION ELIGIBILITY CRITERIA
- Provide adequate tissue for PD-L1 testing
- \* Fresh tissue or archival tissue can be used. Sample must be at least core needle biopsy. Fine needle aspiration is not adequate. This specimen submission is mandatory prior to registration as results will be used for stratification
- REGISTRATION ELIGIBILITY CRITERIA
- Biopsy-proven advanced cutaneous squamous cell carcinoma. Advanced disease is defined as either metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma not amenable to curative surgical resection, or the patient declines surgical resection
- The patient must have at least one lesion that is measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to registration is required
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- If human immunodeficiency virus (HIV) positive the HIV viral load must be \< 200 copies/mL and CD4 count \> 200. If an HIV positive patient is on highly active antiretroviral therapy (HAART) the patient must have been so for \> 4 weeks
- Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Calculated creatinine clearance \>= 30 mL/min
- Total bilirubin =\< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferases (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
You may not qualify if:
- Patients who received prior treatment with cetuximab as palliative treatment for advanced cutaneous squamous cell carcinoma (cSCC) are excluded. Patients that received cetuximab based chemoradiation (either definitive or adjuvant) as prior treatment for locally advanced disease are eligible as long as the last dosage was given \>= 6 months prior to registration
- Patients who received prior cetuximab and had a severe infusion reaction requiring discontinuation of cetuximab are excluded
- Patients treated with prior anti-PD-1 or anti-PD-L1 monoclonal antibodies (mAbs) are excluded
- Patients cannot have received treatment with radiation or chemotherapy including another investigational agent within 2 weeks of registration. Other than as stated above for cetuximab there are no limits on the number of lines of other therapies given for advanced cSCC
- Patients with a "currently active" second malignancy will be excluded with the exception of other non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for 3 years
- No history of the following:
- Autoimmune disease (including inflammatory bowel disease) with the exception of patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment
- Non-infectious pneumonitis that required steroids within 5 years
- Organ transplant including prior stem cell transplant
- Receipt of a live vaccine =\< 4 weeks
- Cerebral vascular accident/stroke within 6 months of enrollment
- Myocardial infarction within 6 months of enrollment
- Active unstable angina
- Congestive heart failure (\>= New York Heart Association Classification class II)
- Serious cardiac arrhythmia requiring medication. Whether an arrhythmia is considered "serious" is at the discretion of the investigator
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (428)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska, 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska, 99508, United States
Katmai Oncology Group
Anchorage, Alaska, 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
Epic Care-Dublin
Dublin, California, 94568, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Epic Care Partners in Cancer Care
Emeryville, California, 94608, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Keck Medical Center of USC Pasadena
Pasadena, California, 91105, United States
Epic Care Cyberknife Center
Walnut Creek, California, 94597, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112, United States
The Women's Imaging Center
Denver, Colorado, 80209, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western Surgical Care
Denver, Colorado, 80220, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
Reid Health
Richmond, Indiana, 47374, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503, United States
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530, United States
Ochsner Medical Center Kenner
Kenner, Louisiana, 70065, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
Huron Medical Center PC
Port Huron, Michigan, 48060, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Riverwood Healthcare Center
Aitkin, Minnesota, 56431, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537, United States
Essentia Health - Fosston
Fosston, Minnesota, 56542, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Mercy Hospital Washington
Washington, Missouri, 63090, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Community Medical Hospital
Missoula, Montana, 59804, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
GenesisCare USA - Henderson
Henderson, Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pebble
Henderson, Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074, United States
Desert West Surgery
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106, United States
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, 89128, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
GenesisCare USA - Fort Apache
Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Mount Carmel East Hospital
Columbus, Ohio, 43213, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Dublin Methodist Hospital
Dublin, Ohio, 43016, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
First Dayton Cancer Care
Kettering, Ohio, 45420, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Saint Rita's Medical Center
Lima, Ohio, 45801, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Newark Radiation Oncology
Newark, Ohio, 43055, United States
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, 43551, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Trinity's Tony Teramana Cancer Center
Steubenville, Ohio, 43952, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
Bay Area Hospital
Coos Bay, Oregon, 97420, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Saint Charles Health System-Redmond
Redmond, Oregon, 97756, United States
UPMC Altoona
Altoona, Pennsylvania, 16601, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009, United States
UPMC Cancer Center-Bethel Park
Bethel Park, Pennsylvania, 15102, United States
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
UPMC Hamot
Erie, Pennsylvania, 16550, United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
Oncology Hematology Associates
Greenville, Pennsylvania, 16125, United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17101, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
IRMC Cancer Center
Indiana, Pennsylvania, 15701, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050, United States
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania, 15108, United States
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, 15666, United States
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania, 15642, United States
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Oncology Hematology Association
Pittsburgh, Pennsylvania, 15215, United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania, 15401, United States
UPMC Cancer Center-Washington
Washington, Pennsylvania, 15301, United States
UPMC West Mifflin-Cancer Center Jefferson
West Mifflin, Pennsylvania, 15122, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
UPMC Susquehanna
Williamsport, Pennsylvania, 17701, United States
Divine Providence Hospital
Williamsport, Pennsylvania, 17754, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503, United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632, United States
Jefferson Healthcare
Port Townsend, Washington, 98368, United States
Valley Medical Center
Renton, Washington, 98055, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Zandberg DP, Allred JB, Rosenberg AJ, Kaczmar JM, Swiecicki P, Julian RA, Poklepovic AS, Bauman JR, Phan MD, Saba NF, Rivera E, Rowland K, Davar D, Cordes J, Ho AL, Zhang M, Berg SA, Munster PN, Schwartz GK. Phase II (Alliance A091802) Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma. J Clin Oncol. 2025 Jul 20;43(21):2398-2408. doi: 10.1200/JCO-25-00759. Epub 2025 May 31.
PMID: 40448574DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dan P. Zandberg, MD
University of Pittsburgh Medical Center Hillman Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2019
First Posted
May 10, 2019
Study Start
June 17, 2019
Primary Completion
February 26, 2025
Study Completion (Estimated)
December 1, 2028
Last Updated
February 5, 2026
Record last verified: 2026-02