PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 29, 2017
End Date:May 9, 2022
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com
Phone:844-734-6643

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A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

The primary objective is to estimate the overall response rate (ORR) for metastatic Basal
Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when
treated with REGN2810 as a monotherapy


Key Inclusion Criteria:

- Confirmed diagnosis of invasive BCC

- Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI
therapy

- At least 1 measurable lesion

- ≥18 years of age

- Hepatic function, renal function, bone marrow function in defined lab-value-ranges

- Anticipated life expectancy >12 weeks

- Consent to provide archived tumor biopsy material (all patients)

- Group 2: consent to undergo research biopsies

- Group 2: must not be a candidate for radiation therapy or surgery

- Comply with study procedures and site visits

- Sign Subject Information Sheet and Informed Consent Form

Key Exclusion Criteria:

- Ongoing or recent significant autoimmune disease

- Prior treatment with specific pathway-blockers (PD-1/PD-L1)

- Prior treatment with immune-modulating agents within 28 days before REGN2810

- Untreated brain metastasis that may be considered active

- Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
treatment with REGN2810

- Active infections requiring therapy, including HIV, hepatitis

- Pneumonitis within the last 5 years

- Cancer treatment other than radiation therapy, including investigational or standard
of care, within 30 days prior to treatment with REGN2810

- Documented allergic reactions or similar to antibody treatments

- Concurrent malignancies other than BCC, other than those with negligible risk of
metastases or death

- Any acute or chronic psychiatric problems

- Having received a solid organ transplantation

- Inability to undergo contrast radiological assessments

- Breastfeeding, pregnant, women of childbearing potential not using contraception

Note: Other protocol-defined inclusion/exclusion criteria apply
We found this trial at
21
sites
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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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Boston, Massachusetts 02115
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Charleston, South Carolina 29414
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13001 East 17th Place
Denver, Colorado 80045
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Hershey, Pennsylvania 17033
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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Louisville, Kentucky 40207
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New York, New York 10029
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625 North 6th Street
Phoenix, Arizona 85004
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84112
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San Francisco, California 94115
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Summit, New Jersey 07901
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