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: Active

Description

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

Eligibility Criteria

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 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

Locations & Contacts

Arizona

Phoenix
University of Arizona Cancer Center at Saint Joseph's
Status: Active
Contact: Aarthi Raman
Phone: 602-287-2683
Email: araman@email.arizona.edu
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
San Diego
University of California San Diego
Status: Active
Name Not Available
San Francisco
UCSF Medical Center-Mount Zion
Status: Temporarily closed to accrual
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: In review
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

New York
Icahn School of Medicine at Mount Sinai
Status: Approved
Name Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Regeneron Pharmaceuticals, Inc.

Trial IDs

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