Testing Atezolizumab in Patients >= 2 Years Old With Newly Diagnosed, Unresectable, or Metastatic Clear Cell Sarcoma or Chondrosarcoma

Titre officiel

A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Chondrosarcoma and Clear Cell Sarcoma

Sommaire:

Cet essai de phase II étudie l’efficacité de l’atezolizumab dans le traitement des patients atteints d’un chondrosarcome ou d’un sarcome à cellules claires récemment diagnostiqué, qui ne peut être retiré par chirurgie (non résécable) ou qui s’est propagé à d’autres parties du corps (métastatique). L’immunothérapie au moyen d’anticorps monoclonaux, comme l’atezolizumab, 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:

  • Objective response rates (ORR)
Secondary Outcome:
  • Duration of response (DOR) or change in clinical symptoms
  • Progression-free survival (PFS) time
  • Number of activated CD8+ T cells infiltrating the tumour
Primary Objectives:
  • Determine the objective response rates (ORR) using Response Evaluation Criteria in Solid Tumours (RECIST) version (v) 1.1 of atezolizumab in adult (>= 18 years) patients with clear cell sarcoma (CCS) and chondrosarcoma (CS).
Secondary Objectives:
  • Determine duration of response (DOR) using RECIST v 1.1 and/or change in clinical symptoms (time frame: baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination).
  • Measure progression-free survival (PFS) time (time frame: baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination).
  • Assess the number of activated CD8+ T cells infiltrating the tumour before and after atezolizumab treatment, and correlate treatment-induced changes with clinical response.
Exploratory Objectives:
  • Compare RECIST v 1.1 versus (vs) immune RECIST (iRECIST) in patients with CCS and CS on atezolizumab.
  • Examine changes in PD-1/PD-L1 expression in the tumour microenvironment before and after atezolizumab treatment, and correlate treatment-induced changes with clinical response.
  • Evaluate potential associations between atezolizumab activity and tumour genomic alterations.
Outline:

Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up to 90 days.

Voir cet essai sur ClinicalTrials.gov

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