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

NCT ID: NCT03944941

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

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.

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 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.

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

Conditions

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Skin Squamous Cell Carcinoma Metastatic Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (Avelumab)

Patients 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.

Group Type ACTIVE_COMPARATOR

Avelumab

Intervention Type DRUG

Given IV

Arm II (Avelumab, cetuximab)

Patients 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.

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

Given IV

Cetuximab

Intervention Type DRUG

Given IV

Interventions

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Avelumab

Given IV

Intervention Type DRUG

Cetuximab

Given IV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan P. Zandberg, MD

Role: STUDY_CHAIR

University of Pittsburgh Medical Center Hillman Cancer Center

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Site Status

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Site Status

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Kingman Regional Medical Center

Kingman, Arizona, United States

Site Status

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Site Status

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status

PCR Oncology

Arroyo Grande, California, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

Epic Care-Dublin

Dublin, California, United States

Site Status

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Tumor Institute

Oakland, California, United States

Site Status

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Site Status

Epic Care Cyberknife Center

Walnut Creek, California, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Site Status

The Women's Imaging Center

Denver, Colorado, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Western Surgical Care

Denver, Colorado, United States

Site Status

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

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

Savannah, Georgia, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Site Status

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

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Saint Anthony's Health

Alton, Illinois, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Site Status

SIH Cancer Institute

Carterville, Illinois, United States

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Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

Carle at The Riverfront

Danville, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

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Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

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Illinois CancerCare-Macomb

Macomb, Illinois, United States

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Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

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UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Site Status

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

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Illinois CancerCare-Peoria

Peoria, Illinois, United States

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Methodist Medical Center of Illinois

Peoria, Illinois, United States

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Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Site Status

Reid Health

Richmond, Indiana, United States

Site Status

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status

McFarland Clinic - Boone

Boone, Iowa, United States

Site Status

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Site Status

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, United States

Site Status

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

Site Status

Trinity Regional Medical Center

Fort Dodge, Iowa, United States

Site Status

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

Site Status

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Site Status

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Site Status

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Site Status

Ochsner Medical Center Kenner

Kenner, Louisiana, United States

Site Status

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Site Status

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Site Status

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Site Status

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Site Status

Huron Medical Center PC

Port Huron, Michigan, United States

Site Status

Lake Huron Medical Center

Port Huron, Michigan, United States

Site Status

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Site Status

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status

Riverwood Healthcare Center

Aitkin, Minnesota, United States

Site Status

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status

Cambridge Medical Center

Cambridge, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Site Status

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, United States

Site Status

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Site Status

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Lake Region Healthcare Corporation-Cancer Care

Fergus Falls, Minnesota, United States

Site Status

Essentia Health - Fosston

Fosston, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Site Status

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status

Monticello Cancer Center

Monticello, Minnesota, United States

Site Status

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status

Essentia Health - Park Rapids

Park Rapids, Minnesota, United States

Site Status

Fairview Northland Medical Center

Princeton, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Essentia Health Sandstone

Sandstone, Minnesota, United States

Site Status

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Site Status

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Site Status

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Site Status

Cox Cancer Center Branson

Branson, Missouri, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status

Capital Region Southwest Campus

Jefferson City, Missouri, United States

Site Status

Freeman Health System

Joplin, Missouri, United States

Site Status

Mercy Hospital Joplin

Joplin, Missouri, United States

Site Status

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Site Status

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Hospital South

St Louis, Missouri, United States

Site Status

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Site Status

Mercy Hospital Washington

Washington, Missouri, United States

Site Status

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

Site Status

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

Site Status

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

Site Status

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Site Status

GenesisCare USA - Henderson

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Green Valley

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Pebble

Henderson, Nevada, United States

Site Status

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Pecos

Las Vegas, Nevada, United States

Site Status

Desert West Surgery

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Central

Las Vegas, Nevada, United States

Site Status

GenesisCare USA - Las Vegas

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, United States

Site Status

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, United States

Site Status

Las Vegas Prostate Cancer Center

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Sunset

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Southwest

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Ann M Wierman MD LTD

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

GenesisCare USA - Vegas Tenaya

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Cathedral Rock

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Smoke Ranch

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Site Status

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Site Status

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

GenesisCare USA - Fort Apache

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Site Status

University Cancer Center

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Saint Mary's Regional Medical Center

Reno, Nevada, United States

Site Status

Radiation Oncology Associates

Reno, Nevada, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Site Status

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States

Site Status

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, United States

Site Status

Indu and Raj Soin Medical Center

Beavercreek, Ohio, United States

Site Status

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Site Status

Saint Elizabeth Boardman Hospital

Boardman, Ohio, United States

Site Status

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, United States

Site Status

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Mount Carmel East Hospital

Columbus, Ohio, United States

Site Status

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status

Mount Carmel Health Center West

Columbus, Ohio, United States

Site Status

Doctors Hospital

Columbus, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Dayton Physician LLC-Miami Valley Hospital North

Dayton, Ohio, United States

Site Status

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Dublin Methodist Hospital

Dublin, Ohio, United States

Site Status

Armes Family Cancer Center

Findlay, Ohio, United States

Site Status

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status

Orion Cancer Care

Findlay, Ohio, United States

Site Status

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Site Status

Central Ohio Breast and Endocrine Surgery

Gahanna, Ohio, United States

Site Status

Dayton Physicians LLC-Wayne

Greenville, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Site Status

Greater Dayton Cancer Center

Kettering, Ohio, United States

Site Status

First Dayton Cancer Care

Kettering, Ohio, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Saint Rita's Medical Center

Lima, Ohio, United States

Site Status

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

Site Status

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

OhioHealth Marion General Hospital

Marion, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Newark Radiation Oncology

Newark, Ohio, United States

Site Status

Mercy Health Perrysburg Cancer Center

Perrysburg, Ohio, United States

Site Status

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Site Status

Springfield Regional Cancer Center

Springfield, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

Trinity's Tony Teramana Cancer Center

Steubenville, Ohio, United States

Site Status

Saint Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status

Dayton Physicians LLC - Troy

Troy, Ohio, United States

Site Status

Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Saint Joseph Warren Hospital

Warren, Ohio, United States

Site Status

Saint Ann's Hospital

Westerville, Ohio, United States

Site Status

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

Site Status

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, United States

Site Status

Saint Charles Health System

Bend, Oregon, United States

Site Status

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, United States

Site Status

Bay Area Hospital

Coos Bay, Oregon, United States

Site Status

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status

Saint Charles Health System-Redmond

Redmond, Oregon, United States

Site Status

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, United States

Site Status

UPMC Cancer Center-Bethel Park

Bethel Park, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center at Butler Health System

Butler, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Site Status

UPMC Hamot

Erie, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

Site Status

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

Site Status

Oncology Hematology Associates

Greenville, Pennsylvania, United States

Site Status

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, United States

Site Status

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, United States

Site Status

IRMC Cancer Center

Indiana, Pennsylvania, United States

Site Status

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Site Status

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center in Coraopolis

Moon Township, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center - Part of Frick Hospital

Mount Pleasant, Pennsylvania, United States

Site Status

Arnold Palmer Cancer Center Medical Oncology Norwin

N. Huntingdon, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Oncology Hematology Association

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, United States

Site Status

Community Medical Center

Scranton, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Selinsgrove

Selinsgrove, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, United States

Site Status

Geisinger Medical Group

State College, Pennsylvania, United States

Site Status

UPMC Cancer Center-Uniontown

Uniontown, Pennsylvania, United States

Site Status

UPMC Cancer Center-Washington

Washington, Pennsylvania, United States

Site Status

UPMC West Mifflin-Cancer Center Jefferson

West Mifflin, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

UPMC Susquehanna

Williamsport, Pennsylvania, United States

Site Status

Divine Providence Hospital

Williamsport, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Site Status

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, United States

Site Status

Overlake Medical Center

Bellevue, Washington, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Providence Regional Cancer System-Centralia

Centralia, Washington, United States

Site Status

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Site Status

Providence Regional Cancer Partnership

Everett, Washington, United States

Site Status

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Site Status

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Site Status

Providence Regional Cancer System-Lacey

Lacey, Washington, United States

Site Status

PeaceHealth Saint John Medical Center

Longview, Washington, United States

Site Status

Jefferson Healthcare

Port Townsend, Washington, United States

Site Status

Valley Medical Center

Renton, Washington, United States

Site Status

Pacific Gynecology Specialists

Seattle, Washington, United States

Site Status

Swedish Medical Center-Ballard Campus

Seattle, Washington, United States

Site Status

Swedish Medical Center-Cherry Hill

Seattle, Washington, United States

Site Status

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, United States

Site Status

Providence Regional Cancer System-Shelton

Shelton, Washington, United States

Site Status

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, United States

Site Status

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States

Site Status

Providence Regional Cancer System-Yelm

Yelm, Washington, United States

Site Status

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Site Status

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, United States

Site Status

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

Site Status

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status

Cheyenne Regional Medical Center-West

Cheyenne, Wyoming, United States

Site Status

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40448574 (View on PubMed)

Other Identifiers

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NCI-2018-02652

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A091802

Identifier Type: -

Identifier Source: org_study_id

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