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ACTIVE NOT RECRUITING

NCT03944941

PHASE2

Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

Official title: Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-06-17

Completion Date

2028-12-01

Last Updated

2026-02-05

Healthy Volunteers

Conditions

Skin Squamous Cell Carcinoma Metastatic Skin Cancer

Interventions

DRUG

Avelumab

Given IV

DRUG

Cetuximab

Given IV

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 * Active infection requiring systemic treatment * Use of immunosuppressive medication =\< 7 days of registration, EXCEPT for the following: * Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) * Systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent * Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] 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

Locations (428)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

PCR Oncology

Arroyo Grande, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Epic Care-Dublin

Dublin, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

The Women's Imaging Center

Denver, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Western Surgical Care

Denver, Colorado, United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

North Colorado Medical Center

Greeley, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Saint Anthony's Health

Alton, Illinois, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

SIH Cancer Institute

Carterville, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

The Carle Foundation Hospital

Urbana, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Reid Health

Richmond, Indiana, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, United States

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Broadlawns Medical Center

Des Moines, Iowa, United States

Iowa Lutheran Hospital

Des Moines, Iowa, United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

Trinity Regional Medical Center

Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Methodist West Hospital

West Des Moines, Iowa, United States

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Ochsner Medical Center Kenner

Kenner, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Borgess Medical Center

Kalamazoo, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Huron Medical Center PC

Port Huron, Michigan, United States

Lake Huron Medical Center

Port Huron, Michigan, United States

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Riverwood Healthcare Center

Aitkin, Minnesota, United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Cambridge Medical Center

Cambridge, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Miller-Dwan Hospital

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Lake Region Healthcare Corporation-Cancer Care

Fergus Falls, Minnesota, United States

Essentia Health - Fosston

Fosston, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Health Partners Inc

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

Essentia Health - Park Rapids

Park Rapids, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Cox Cancer Center Branson

Branson, Missouri, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

Capital Region Southwest Campus

Jefferson City, Missouri, United States

Freeman Health System

Joplin, Missouri, United States

Mercy Hospital Joplin

Joplin, Missouri, United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Mercy Hospital Washington

Washington, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Saint Peter's Community Hospital

Helena, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Community Medical Hospital

Missoula, Montana, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

GenesisCare USA - Henderson

Henderson, Nevada, United States

Las Vegas Urology - Green Valley

Henderson, Nevada, United States

Las Vegas Urology - Pebble

Henderson, Nevada, United States

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, United States

Las Vegas Urology - Pecos