Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:May 11, 2016
End Date:August 11, 2021
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com

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A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

To estimate the clinical benefit of cemiplimab monotherapy for patients with metastatic
(nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Groups 1 and 3) or with
unresectable locally advanced CSCC (Group 2), or with advanced CSCC [metastatic (nodal or
distal) or unresectable locally advanced] treated (Group 4) as measured by overall response
rate (ORR), according to central review.


Key Inclusion Criteria:

- At least 1 measurable lesion

- Eastern Cooperative Oncology Group (ECOG) performance status ≤1

- Adequate bone marrow function

- Adequate renal function

- Adequate hepatic function

- Archived or newly obtained tumor material

- Patients must consent to undergo biopsies of CSCC lesions (Groups 2 and 4 only)

- Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
required treatment with systemic immunosuppressive treatments, which may suggest risk
for immune-related adverse events

- Prior treatment with an agent that blocks the PD-1/PD-L1pathway

- Prior treatment with a BRAF inhibitor

- Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
the first dose of cemiplimab, or associated with immune-mediated adverse events that
were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated
with toxicity that resulted in discontinuation of the immune-modulating agent.
Examples of immune-modulating agents include therapeutic vaccines, cytokine
treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB
(CD137), or OX-40.

- Untreated brain metastasis(es) that may be considered active

- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
4 weeks prior to the first dose of cemiplimab

- Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
hepatitis B virus or hepatitis C virus

- History of non-infectious pneumonitis within the last 5 years

- Allergic reactions or acute hypersensitivity reaction attributed to antibody
treatments

- Known allergy to doxycycline or tetracycline

- Patients with a history of solid organ transplant

- Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
clinical laboratory abnormality that renders the patient unsuitable

Other protocol-defined inclusion/exclusion criteria apply
We found this trial at
27
sites
Saint Louis, Missouri 63110
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Charleston, South Carolina 29414
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Charleston, SC
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Duarte, California 91010
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Duarte, CA
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Easton, PA
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Hershey, Pennsylvania 17033
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Hershey, PA
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Houston, Texas 77030
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Houston, TX
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Louisville, Kentucky 40207
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Louisville, KY
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Miami Beach, Florida 33140
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Miami Beach, FL
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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New York, NY
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8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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Omaha, NE
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625 North 6th Street
Phoenix, Arizona 85013
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Redwood City, California 94063
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Redwood City, CA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Salt Lake City, Utah 84112
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Salt Lake City, UT
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San Diego, California 92093
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San Diego, CA
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St Leonards, New South Wales 2065
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St Leonards,
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Tampa, Florida 33612
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Tampa, FL
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