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

Official Title

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

Summary:

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

Trial Description

Primary Outcome:

  • Overall Response Rate (ORR) for metastatic Basal Cell Carcinoma (BCC)
  • ORR for unresectable locally advanced BCC
Secondary Outcome:
  • Duration of Response (DOR)
  • Complete Response (CR) Rate
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Change in scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
  • Change in scores of patient-reported outcomes in Skindex-16
  • Incidence of treatment emergent adverse events (TEAEs)
  • Concentration at end of infusion (Ceoi)
  • Pre-infusion concentration (Ctrough)
  • Time of end of infusion (teoi)
  • Anti-REGN2810 antibodies

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society