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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

Trial Status: Closed to Accrual

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

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

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 cemiplimab
  • Untreated brain metastasis that may be considered active
  • Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with cemiplimab
  • 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 cemiplimab
  • 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

Arizona

Phoenix
Cancer Center at Saint Joseph's
Status: ACTIVE
Contact: Karen Jane Hanson
Phone: 602-827-2666
Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL

Illinois

Chicago
Northwestern University
Status: IN_REVIEW

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: WITHDRAWN

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New York

New York
Icahn School of Medicine at Mount Sinai
Status: CLOSED_TO_ACCRUAL
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Regeneron Pharmaceuticals, Inc.

  • Primary ID R2810-ONC-1620
  • Secondary IDs NCI-2017-01073, 2016-003122-16
  • Clinicaltrials.gov ID NCT03132636