Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumours

Titre officiel

A Phase 2 Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine Carcinomas

Sommaire:

Cette étude de phase II évalue l’efficacité de l’association du XL184 (cabozantinib), du nivolumab et de l’ipilimumab pour le traitement des patients atteints de tumeurs neuroendocrines peu différenciées (c’est-à-dire des tumeurs neuroendocrines qui ne ressemblent pas au tissu normal dont elles sont issues). Le cabozantinib pourrait faire cesser la croissance des cellules tumorales en bloquant certaines enzymes nécessaires à la croissance cellulaire. L’immunothérapie au moyen d’anticorps monoclonaux, comme le nivolumab et l’ipilimumab, 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. L’administration de cabozantinib, de nivolumab et d’ipilimumab peut faire régresser le cancer.

Description de l'essai

Primary Outcome:

  • Overall response rate (ORR)
Secondary Outcome:
  • Progression free survival (PFS)
  • Incidence of adverse events
  • Disease control rate (DCR)
  • Duration of response (DOR)
PRIMARY OBJECTIVE:
  • To evaluate the overall response rate (ORR) associated with the combination of XL184 (cabozantinib), nivolumab, and ipilimumab in patients with advanced poorly-differentiated neuroendocrine carcinomas (NECs), after the failure of at least one line of prior therapy.
SECONDARY OBJECTIVES:
  • To evaluate progression-free survival (PFS).
  • To measure the safety and tolerability of the combination of XL184 (cabozantinib), nivolumab, and ipilimumab in patients with advanced, poorly-differentiated NECs.
  • To evaluate disease control rate (DCR).
  • To measure duration of response (DOR).
  • To describe the tumour molecular profile using whole exome sequencing (WES) and correlate it with treatment outcome.
  • To describe the tumour molecular profile using ribonucleic acid (RNA) sequencing (RNAseq) and correlate it with treatment outcome.
EXPLORATORY OBJECTIVES:
  • To measure the tumour-infiltrating CD8+ T lymphocytes in pre- and on-treatment biopsies.
  • To measure tumour-infiltrating myeloid derived suppressor cells (MDSCs) in pre- and on-treatment biopsies.
  • To measure tumour-infiltrating tumour-associated macrophages (TAM) in the pre and on-treatment biopsies.
  • To measure the expression of programmed death-ligand 1 (PD-L1) in tumour cells and infiltrating immune cells.
OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-21 of cycles 1-4 and days 1-28 of subsequent cycles, nivolumab intravenously (IV) over 30 minutes on day 1, and ipilimumab IV over 90 minutes on day 1 of cycles 1-4 only. Treatment repeats every 21 for 4 cycles then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks, and then every 3 months thereafter.

Voir cet essai sur ClinicalTrials.gov

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