Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

Titre officiel

A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)

Sommaire:

Cet essai de phase Ib vise à étudier les effets secondaires du nivolumab et à vérifier son efficacité dans le traitement des patients atteints de troubles auto-immuns et d’un cancer qui s’est propagé à d’autres parties du corps ou qui ne peut pas être réséqué. L’immunothérapie au moyen d’anticorps monoclonaux, comme le nivolumab, peut aider le système immunitaire de l’organisme à attaquer le cancer et entraver la capacité des cellules tumorales à croître et à se propager.

Description de l'essai

Primary Outcome:

  • Incidence of adverse events
  • Change in disease assessments
  • Overall response rate
  • Changes in serum chemokines and circulating immune cells over time
  • Gene expression in normal tissues
  • Clinical measures of interest

PRIMARY OBJECTIVE:

  • To assess the overall safety, including the incidence of dose-limiting toxicity (DLT), and other toxicities associated with the use of the anti-programmed death 1 (PD-1) antibody nivolumab in patients with varying severity of dermatomyositis (DM)/systemic sclerosis (SSc), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD) (ulcerative colitis [UC] and Crohn's disease [CD]), multiple sclerosis (MS), Sjogren's syndrome [SjS], and other autoimmune diseases.

SECONDARY OBJECTIVES:

  • To evaluate the efficacy of nivolumab in terms of objective response rates (ORRs), progression-free survival (PFS), and overall survival (OS) in patients with cancer and DM/SSc, RA, SLE, IBD (UC and CD), MS, SjS, and other autoimmune diseases.
  • To observe and record anti-tumour activity.
  • To propose dosing recommendations for anti-PD-1 antibodies based on the severity of the autoimmune disorder.
  • To evaluate the impact of nivolumab on the disease severity indices for: DM/SSc, RA, SLE, IBD: UC and CD, not specified (NS), MS.
  • To perform molecular profiling assays on malignant and normal tissues, including, but not limited to, ribonucleic acid (RNA) sequencing, in order to: identify potential predictive and prognostic biomarkers beyond any genomic alteration by which treatment may be assigned, and identify resistance mechanisms using genomic deoxyribonucleic acid (DNA)- and ribonucleic acid (RNA)-based assessment platforms.

OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 100 days.

Voir cet essai sur ClinicalTrials.gov

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