Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)

Titre officiel

An Open-Label Phase 1B/2 Study to Evaluate the Safety and Efficacy of Tabelecleucel in Combination With Pembrolizumab in Subjects With Platinum-pretreated, Recurrent/Metastatic Epstein-Barr Virus-Associated Nasopharyngeal Carcinoma

Sommaire:

Cette étude multicentrique ouverte de phase 1b/2 à groupe unique vise à évaluer l’innocuité et l’efficacité du tabelecleucel en association avec le pembrolizumab dans le traitement de sujets atteints d’un carcinome nasopharyngé associé au virus Epstein-Barr (CNP VEB+) prétraité au platine, récidivant ou métastatique.

Description de l'essai

Primary Outcome:

  • Phase 1b: Incidence of dose-limiting toxicities (DLTs)
  • Phase 1b: Maximum tolerated dose (MTD)
  • Phase 1b: Recommended phase 2 dose (RP2D) of tabelecleucel in combination with pembrolizumab
  • Objective response rate (ORR)
Secondary Outcome:
  • Complete Response (CR) rate
  • Duration of response (DOR)
  • Progression-free survival (PFS)
  • Overall Survival (OS)
  • Immune response rate (iRR)
  • Duration of immune response (DOiR)
This is a multicentre, open-label, single-arm phase 1b/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic EBV+ NPC. Tabelecleucel will be selected for each subject from the bank of available tabelecleucel cell products based on matching ≥ 2 human leukocyte antigen (HLA) alleles, at least one of which is a restricting HLA allele, shared between the tabelecleucel donor and the subject's EBV+ NPC. Sites will provide high resolution HLA typing of the subject and other information as required by the protocol. Phase 1b will identify the maximum tolerated dose (MTD) and characterize the dose limiting toxicity (DLT) for tabelecleucel in combination with pembrolizumab in up to 24 subjects. In the absence of an MTD, the recommended Phase 2 dose will be identified. Phase 2 will evaluate the safety and efficacy of the combination in 36 subjects at the recommended dose level from Phase 1b.

Voir cet essai sur ClinicalTrials.gov

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