A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine (ALKS 4230) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumours (ARTISTRY-2)

Official Title

A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours - ARTISTRY-2 (001)

Summary:

This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.

Trial Description

Primary Outcome:

  • Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A
  • Number of subjects experiencing AEs that are both serious and drug-related in Part B
  • Clinical Activity of combination treatment with ALKS 4230 and pembrolizumab in each Part B tumour type.
Secondary Outcome:
  • Proportion of subjects with objective evidence of Complete Response (CR)/immune CR (iCR)
  • Proportion of subjects with objective evidence of Partial Response (PR)/immune PR (iPR)
  • Duration of response in subjects with CR/iCR
  • Duration of response in subjects with PR/iPR
  • Non-progression for Part B
  • Overall survival for Part B
  • Serum concentrations of ALKS 4230 will be determined at various time points
  • Serum will be assayed for the presence of anti-ALKS 4230 antibodies
  • Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
  • Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points
This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumours.

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