A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumours

Official Title

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

Summary:

To better understand the safety and tolerability of ALKS 4230 in humans

Trial Description

Primary Outcome:

  • Characterization of adverse events (AEs) and dose-limiting toxicities (DLT) in study Part A
  • Incidence of drug-related AEs in study Part B
  • Overall response rate (ORR) of ALKS 4230 monotherapy in patients with melanoma or renal cell carcinoma (Part B) and in combination with pembrolizumab in patients with advanced solid tumours (Part C)
Secondary Outcome:
  • Disease Control Rate
  • Duration of response in subjects with CR/iCR or PR/iPR
  • 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
To investigate the safety and tolerability of ALKS 4230, determine the recommended Phase 2 dose (RP2D) and assess anti-tumour activity in Monotherapy and ALKS 4230 in Combination with pembrolizumab.

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