Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Inhibito

Brief 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

Detailed Summary:
Sponsor: Regeneron Pharmaceuticals

Current Primary Outcome:

• Overall Response Rate (ORR) for metastatic Basal Cell Carcinoma (BCC) [ Time Frame: Baseline to 93 weeks ]
  ORR for metastatic BCC measured by RECIST version 1.1
• ORR for unresectable locally advanced BCC [ Time Frame: Baseline to 93 weeks ]
  ORR for unresectable locally advanced BCC measured by Composite Response Criteria

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Duration of Response (DOR) [ Time Frame: Time from the first observed confirmed response to disease progression or death, up to approximately 119 weeks ]
  DOR assessed by time from the first observed confirmed response (CR or PR) to disease progression or death, up to approximately 119 weeks (from first response assessment until end of post-treatment follow up)
• Complete Response (CR) Rate [ Time Frame: From date of treatment until best overall response of CR after starting REGN2810, up to approximately 119 weeks ]
  CR rate (per central review) assessed from date of treatment until best overall response of CR after starting REGN2810 treatment, up to approximately 119 weeks (from first response assessment until end of post-treatment follow up).
• Progression Free Survival (PFS) [ Time Frame: From date of treatment until date of death up to approximately 119 weeks ]
  PFS assessed from date of treatment until date of death, up to approximately 119 weeks
• Overall Survival (OS) [ Time Frame: From date of treatment until date of death, up to approximately 119 weeks ]
  OS assessed from date of treatment until date of death, up to approximately 119 weeks
• 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) [ Time Frame: From date of treatment until date of first documented progression or date of death, up to approximately 93 weeks ]
  Change in scores of patient-reported outcomes in EORTC QLQ-C30 assessed from date of treatment until date of first documented progression or date of death, up to approximately 93 weeks
• Change in scores of patient-reported outcomes in Skindex-16 [ Time Frame: From date of treatment until date of first documented progression or date of death, up to approximately 93 weeks ]
  From date of treatment until date of first documented progression or date of death, assessed up to approximately 93 weeks

Original Secondary Outcome: Same as current

Information By: Regeneron Pharmaceuticals

Dates:
Date Received: April 24, 2017
Date Started: May 2017
Date Completion: December 2020
Last Updated: April 24, 2017
Last Verified: April 2017