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Testing what Happens when an Immunotherapy Drug (Avelumab) Is Added to a Usual Drug Treatment (Cetuximab) Compared to Avelumab by Itself in the Treatment of Advanced Squamous Cell Carcinoma of the Skin (cSCC)

Trial Status: Active

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 (advanced). 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.

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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
  • Comorbid conditions (excluded): * Active infection requiring systemic treatment * Use of immunosuppressive medication =< 7 days of registration, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). * Other severe acute or chronic medical conditions including but not limited to immune colitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Oncology and Hematology LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Radiation Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Kingman
Kingman Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171
Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
Contact: Site Public Contact
University of Arizona Cancer Center-North Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-327-2873
University of Arizona Cancer Center-Orange Grove Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 520-694-8900

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-378-9373

California

Arroyo Grande
PCR Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 818-847-4793
Dublin
Epic Care-Dublin
Status: ACTIVE
Contact: Site Public Contact
Phone: 925-875-1677
Emeryville
Bay Area Breast Surgeons Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-835-9900
Epic Care Partners in Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-629-6682
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Martinez
Contra Costa Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 925-957-5400
Newport Beach
USC Norris Oncology / Hematology-Newport Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Oakland
Alta Bates Summit Medical Center - Summit Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-204-1414
Bay Area Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-465-2242
Pasadena
Keck Medical Center of USC Pasadena
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Walnut Creek
Epic Care Cyberknife Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-465-8016

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Post Falls
Kootenai Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212
Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: ACTIVE
Contact: Site Public Contact
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Orland Park
University of Chicago Medicine-Orland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212

Iowa

Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Trinity Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-574-8302
Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-343-1000

Louisiana

Kenner
Ochsner Medical Center Kenner
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-464-8314
New Orleans
Ochsner Medical Center Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-703-8712

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-888-8823

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
Borgess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Niles
Lakeland Hospital Niles
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Port Huron
Huron Medical Center PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Lake Huron Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Aitkin
Riverwood Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Brainerd
Essentia Health Saint Joseph's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minnesota Oncology - Burnsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Deer River
Essentia Health - Deer River Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Duluth
Essentia Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Essentia Health Saint Mary's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Miller-Dwan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Fosston
Essentia Health - Fosston
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Hibbing
Essentia Health Hibbing Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Park Rapids
Essentia Health - Park Rapids
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Princeton
Fairview Northland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Sandstone
Essentia Health Sandstone
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Virginia
Essentia Health Virginia Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Waconia
Ridgeview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Wyoming
Fairview Lakes Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Branson
Cox Cancer Center Branson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-327-3118

Nebraska

Omaha
Nebraska Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Henderson
21st Century Oncology-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Urology - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pebble
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Seven Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas
21st Century Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Vegas Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Ann M Wierman MD LTD
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Shadow
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Town Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Desert West Surgery
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Hope Cancer Care of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Prostate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Cathedral Rock
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pecos
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Smoke Ranch
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Sunset
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at MountainView
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Oakey
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Central
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Southwest
Status: ACTIVE
Contact: Site Public Contact
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Radiation Oncology Associates
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-996-2879

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-305-6361

North Carolina

Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-587-9084

North Dakota

Fargo
Essentia Health Cancer Center-South University Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Jamestown
Essentia Health - Jamestown Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Chillicothe
Adena Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Columbus
Columbus Oncology and Hematology Associates Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Doctors Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Delaware
Delaware Health Center-Grady Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-0227
Grady Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-2403
Dublin
Dublin Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-752-9119
Gahanna
Central Ohio Breast and Endocrine Surgery
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2745
Grove City
Mount Carmel Grove City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Lancaster
Fairfield Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-687-8863
Mansfield
OhioHealth Mansfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Marion
OhioHealth Marion General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Vernon
Knox Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-393-9000
Newark
Licking Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-348-4000
Newark Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Westerville
Saint Ann's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Zanesville
Genesis Healthcare System Cancer Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Altoona
UPMC Altoona
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171
Beaver
UPMC-Heritage Valley Health System Beaver
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-773-7616
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Farrell
UPMC Cancer Center at UPMC Horizon
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-838-1900
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-724-6765
UPMC Pinnacle Harrisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-459-2901
Johnstown
UPMC-Johnstown / John P. Murtha Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 814-534-4724
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-242-7703
McKeesport
UPMC Cancer Center at UPMC McKeesport
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073
Monroeville
UPMC Cancer Center - Monroeville
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171
Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-728-4790
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-955-6084
Pittsburgh
UPMC-Passavant Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-502-3920
UPMC-Saint Margaret
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-784-4900
UPMC-Shadyside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-621-2334
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
Scranton
Community Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-703-4768
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Seneca
UPMC Cancer Center at UPMC Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 814-676-7900
State College
Geisinger Medical Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Williamsport
UPMC Susquehanna
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-598-4282

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321

Tennessee

Knoxville
University of Tennessee - Knoxville
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-544-9773

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-628-1914

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Bellevue
Overlake Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-688-5407
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Centralia
Providence Regional Cancer System-Centralia
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Everett
Providence Regional Cancer Partnership
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-261-3529
Issaquah
Swedish Cancer Institute-Issaquah
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Longview
PeaceHealth Saint John Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-2016
Renton
Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-228-3440
Seattle
Pacific Gynecology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Shelton
Providence Regional Cancer System-Shelton
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Vancouver
PeaceHealth Southwest Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958

Wisconsin

Ashland
Duluth Clinic Ashland
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Northwest Wisconsin Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Marshfield Clinic Stevens Point Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Weston
Marshfield Clinic - Weston Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

Wyoming

Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVE:

I. To evaluate whether treatment with avelumab plus cetuximab prolongs progression free survival (PFS) compared to avelumab alone.

SECONDARY OBJECTIVES:

I. To evaluate the confirmed objective response rate of each treatment arm.

II. To evaluate the clinical benefit rate of each treatment arm.

III. To evaluate the PFS of cetuximab plus avelumab in patients that have progressed on single agent avelumab.

IV. To evaluate the overall survival (OS) for each treatment arm.

V. To evaluate toxicity across treatment arms of avelumab plus cetuximab and avelumab alone.

CORRELATIVE OBJECTIVE:

I. To examine the association between PD-L1 expression and response rate (RR), clinical benefit rate (CBR), PFS and OS in both patients receiving cetuximab and avelumab as well as avelumab alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive avelumab intravenously (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: Patients receive cetuximab IV over 2 hours on days 1 and 15 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.

After completion of study treatment, patients are followed up every 3 months until disease progression, then every 6 months for up to 2 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Dan Paul Zandberg

  • Primary ID A091802
  • Secondary IDs NCI-2018-02652
  • Clinicaltrials.gov ID NCT03944941