Clinical Trial: Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

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

Official Title: A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced

Brief Summary: To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

Detailed Summary: This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).
Sponsor: Immunocore Ltd

Current Primary Outcome: Overall survival defined as the time from patient inclusion to date of death due to any cause [ Time Frame: Survival status will be assessed every 3 months from randomization until death, assessed up to 40 months. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety defined as the number of patients with treatment emergent adverse events, laboratory abnormalities, ECG changes, and/or physical examination findings [ Time Frame: Safety will be assessed from informed consent through 90 days after end of treatment ]
  • Efficacy: Objective response rate (ORR) defined as the proportion of patients achieving an objective response (RECIST v1.1) by Independent Central Review [ Time Frame: ORR will be assessed every 3 months from randomization until disease progression, assessed up to 40 months ]
  • Efficacy: Duration of response (DOR) defined as the time from first documented objective response (RECIST v1.1) by Independent Central Review until the date of documented disease progression [ Time Frame: DOR will be assessed every 3 months from randomization until disease progression, assessed up to 40 months ]
  • Efficacy: Progression free survival (PFS) defined as the time from randomization to the date of progression (RECIST v1.1) by Independent Central Review or death due to any cause [ Time Frame: PFS will be assessed every 3 months from randomization until disease progression or death, assessed up to 40 months ]
  • Efficacy: Disease control rate (DCR) defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1) by Independent Central Review. [ Time Frame: DCR will be assessed every 3 months from randomization until disease progression, assessed up to 40 months ]
  • Quality-of-Life: General health status will be assessed using the EQ-5D,5L questionnaire [ Time Frame: : EQ-5D,5L will be assessed every 6 weeks from randomization for 24 weeks and approximately every 3 months thereafter until death, assessed up to 40 months ]
  • Quality-of-Life: Health related quality of life will be assessed using EORTC QLQ-C30 questionnaire [ Time Frame: EORTC QLQ-C30 will be assessed every 6 weeks from randomization for 24 weeks and approximately every 3 months thereafter until disease progression, assessed up to 40 months ]
  • Pharmacokinetics (IMCgp100 Arm only): Area under the plasma concentration-time curve (AUC) [ Time Frame: AUC will be assessed weekly for 3 weeks and every 6 weeks thereafter until end of treatment, assessed up to 40 months ]
  • Pharmacokinetics (IMCgp100 Arm only): The maximum observed plasma drug concentration after single dose administration (Cmax) [ Time Frame: Cmax will be assessed weekly for 3 weeks and every 6 weeks thereafter until end of treatment, assessed up to 40 months ]
  • Pharmacokinetics (IMCgp100 Arm only): The time to reach maximum plasma concentration (Tmax) [ Time Frame: Tmax will be assessed prior to and after the first three doses of IMCgp100, an average of 3 weeks ]
  • Pharmacokinetics (IMCgp100 Arm only): The elimination half-life (t1/2) [ Time Frame: t1/2 will be assessed prior to and after the first three doses of IMCgp100, an average of 3 weeks ]
  • Pharmacokinetics (IMCgp100 Arm only): To assess the frequency of anti-IMCgp100 antibody formation [ Time Frame: Approximately 5 assessments will be performed between first dose of IMCgp100 and end of treatment, assessed up to 40 months ]


Original Secondary Outcome: Same as current

Information By: Immunocore Ltd

Dates:
Date Received: February 14, 2017
Date Started: June 2017
Date Completion: March 2023
Last Updated: May 11, 2017
Last Verified: May 2017