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

Titre officiel

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

Sommaire:

Évaluer la survie globale des patients adultes atteints d’un mélanome uvéal de stade avancé exprimant le HLA-A*0201 n’ayant jamais été traités, qui reçoivent l’IMCgp100 comparativement au traitement de choix de l’investigateur, soit la dacarbazine, l’ipilimumab ou le pembrolizumab.

Description de l'essai

Primary Outcome:

  • Overall survival defined as the time from patient inclusion to date of death due to any cause
Secondary Outcome:
  • Safety defined as the number of patients with treatment emergent adverse events, laboratory abnormalities, ECG changes, and/or physical examination findings
  • Efficacy: Objective response rate (ORR) defined as the proportion of patients achieving an objective response (RECIST v1.1) by Independent Central Review
  • 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
  • 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
  • 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.
  • Quality-of-Life: General health status will be assessed using the EQ-5D,5L questionnaire
  • Quality-of-Life: Health related quality of life will be assessed using EORTC QLQ-C30 questionnaire
  • Pharmacokinetics (IMCgp100 Arm only): Area under the plasma concentration-time curve (AUC)
  • Pharmacokinetics (IMCgp100 Arm only): The maximum observed plasma drug concentration after single dose administration (Cmax)
  • Pharmacokinetics (IMCgp100 Arm only): The time to reach maximum plasma concentration (Tmax)
  • Pharmacokinetics (IMCgp100 Arm only): The elimination half-life (t1/2)
  • Pharmacokinetics (IMCgp100 Arm only): To assess the frequency of anti-IMCgp100 antibody formation
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).

Voir cet essai sur ClinicalTrials.gov

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