A Study To Evaluate Safety And Therapeutic Activity Of RO6874281 In Combination With Pembrolizumab, In Participants With Advanced Or Metastatic Melanoma

Official Title

An Open-Label, Multicentre, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma

Summary:

This is an open-label, multicentre, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 3 parts: a safety run-in (Part I: Cohorts 1.1. and 1.2) and two expansion parts (Parts II and III). Part II will start once all participants in Cohort 1.1 have completed the observation period. Part III will start once all participants in Cohorts 1.1 and 1.2 have completed the observation period.

Trial Description

Primary Outcome:

  • Percentage of participants with adverse events
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Complete Response Rate (CRR)
  • Disease Control Rate (DCR)
  • Duration of Response
  • Progression Free Survival (PFS)
  • Baseline PD-L1
  • Fibroblast Activation Protein-a (FAP)
  • Change from baseline in density (cell/mm2) of immune cells including CD8+, FOXP3, and PD-L1

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