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

Use our guide to learn which trials are right for you!

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
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Charleston, South Carolina 29414
?
mi
from
Charleston, SC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Duarte, California 91010
?
mi
from
Duarte, CA
Click here to add this to my saved trials
?
mi
from
Easton, PA
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
?
mi
from
Omaha, NE
Click here to add this to my saved trials
625 North 6th Street
Phoenix, Arizona 85013
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
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...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Redwood City, California 94063
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84112
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92093
?
mi
from
San Diego, CA
Click here to add this to my saved trials
St Leonards, New South Wales 2065
?
mi
from
St Leonards,
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials