Clinical Trial: Avelumab in Subjects With Merkel Cell Carcinoma (JAVELIN Merkel 200)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

Brief Summary: This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in subjects with metastatic Merkel cell carcinoma (MCC).

Detailed Summary:
Sponsor: EMD Serono

Current Primary Outcome:

• Part A: Confirmed Best Overall Response (BOR) [ Time Frame: Up to 3 years ]
  BOR is defined as the confirmed best response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as determined by Independent Endpoint Review Committee (IERC), obtained from start of study drug until documented disease progression, assessed every 6 weeks. CR or PR must be confirmed by a subsequent tumor assessment preferably at the next scheduled 6-weekly assessment, but no sooner than 5 weeks after the initial documentation of CR or PR.
• Part B: Durable Response [ Time Frame: Up to 5 years ]
  Durable response is defined as objective response (complete response [CR] or partial response [PR]) according to RECIST 1.1, determined by an IERC, with a duration of at least 6 months

Original Primary Outcome: Confirmed Best Overall Response (BOR) [ Time Frame: Up to 3 years ]

Current Secondary Outcome:

• Part A: Duration of response [ Time Frame: Up to 3 years ]
  Duration of response is defined as time from first observation of response (CR or PR) until first observation of documented disease progression or death when death occurs within 12 weeks of the last tumor assessment whichever occurs first.
• Part A: Progression-Free Survival (PFS) Time [ Time Frame: Up to 3 years ]
  PFS time is defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 12 weeks of the last tumor assessment whichever occurs first.
• Part A: Overall Survival (OS) Time [ Time Frame: Up to 3 years ]
  OS time is defined as the time from first administration of study drug until date of death.
• Part A: Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0 [ Time Frame: Baseline up to 90 days after last dose administration ]
• Part A: Number of subjects with anti-avelumab antibodies [ Time Frame: Up to 3 years ]
• Part A: Concentration at the end of infusion on Day 1 [ Time Frame: Day 1 ]
• Part A: Trough concentrations [ Time Frame: Day 15, 29, 43, 85, 127, 169 ]
• Part B: Confirmed Best Overall Response (BOR) [ Time Frame: Up to 5 years ]
  BOR is defined as the confirmed best response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as determined by Independent Endpoint Review Committee (IERC).
• Part B: Duration of response [ Time Frame: Up to 5 years ]
  Duration of response will be according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as determined by Independent Endpoint Review Committee (IERC).
• Part B: Progression-Free Survival (PFS) Time [ Time Frame: Up to 5 years ]
  PFS will be according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as determined by Independent Endpoint Review Committee (IERC).
• Part B: Overall Survival (OS) Time [ Time Frame: Up to 5 years ]
• Part B: Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0 [ Time Frame: Baseline up to 90 days after last dose administration ]
• Part B: Number of subjects with anti-avelumab antibodies [ Time Frame: Up to 5 years ]
• Part B: Concentration at the end of infusion on Day 1 [ Time Frame: Day 1 ]
• Part B: Trough concentrations [ Time Frame: Day 15, 29, 43, 85, 127, 169 ]
• Part A: Number of Subjects With Response Status According to RECIST 1.1 as Determined by an IERC [ Time Frame: Month 6, Month 12 ]
• Part B: Number of Subjects With Response Status According to RECIST 1.1 as Determined by an IERC [ Time Frame: Up to 5 years ]

Original Secondary Outcome:

• Duration of response [ Time Frame: Up to 3 years ]
  Duration of response is defined as time from first observation of response (CR or PR) until first observation of documented disease progression or death when death occurs within 12 weeks of the last tumor assessment whichever occurs first up to 3 years.
• Progression-Free Survival (PFS) Time [ Time Frame: Up to 3 years ]
  PFS time is defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 12 weeks of the last tumor assessment whichever occurs first up to 3 years.
• Overall Survival (OS) Time [ Time Frame: Up to 3 years ]
  OS time is defined as the time from first administration of study drug until date of death, assessed up to 3 years.
• Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0 [ Time Frame: Baseline up to 10 weeks after last dose administration ]

Dates:
Date Received: June 2, 2014
Date Started: June 30, 2014
Date Completion: May 31, 2019
Last Updated: May 8, 2017
Last Verified: May 2017