Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer

Titre officiel

An Open-Label, Phase III Study of Platinum-Gemcitabine With or Without Nivolumab in the First-Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Sommaire:

Cet essai de phase III compare l’effet de l’ajout du nivolumab à la chimiothérapie habituelle (cisplatine ou carboplatine avec gemcitabine) par rapport à la chimiothérapie standard seule dans le traitement des patients atteints d’un cancer du nasopharynx qui est revenu (récidivant) ou s’est propagé à d’autres endroits du corps (métastatique). L’immunothérapie au moyen d’anticorps monoclonaux, comme le nivolumab, peut aider le système immunitaire de l’organisme à attaquer le cancer et peut entraver la capacité des cellules tumorales à croître et à se propager. Les médicaments de la chimiothérapie, comme le cisplatine, le carboplatine et la gemcitabine, agissent de différentes manières pour arrêter la croissance des cellules tumorales, soit en tuant les cellules, soit en les empêchant de se diviser ou de se propager. L’administration de nivolumab avec la chimiothérapie habituelle peut s’avérer plus efficace que la chimiothérapie standard seule pour traiter les patients atteints d’un cancer du nasopharynx.

Description de l'essai

Primary Outcome:

  • Overall survival (OS)
Secondary Outcome:
  • Locoregional failure
  • Distant metastases
  • Progression-free survival (PFS)
  • Tumour response
  • Incidence of adverse events (AEs)
  • Patient-reported symptomatic toxicities
  • Quality of life
  • Fatigue
  • Progression-free survival by PD-L1 Combined Positive Score (CPS)/Tumour Proportion Score (TPS) cut-off
PRIMARY OBJECTIVE: I. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment improves overall survival (OS) for patients with recurrent and/or metastatic nasopharyngeal carcinoma (NPC). SECONDARY OBJECTIVES:
I. To compare patterns of failure (local-regional relapse and distant metastasis) between treatment arms. II. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment improves the objective tumour response based on Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. III. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment improves progression free survival (PFS) for patients with recurrent and/or metastatic NPC. IV. To evaluate the toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. V. To characterize patient-reported symptomatic toxicities measured by Patient-Reported Outcomes (PRO)-CTCAE. VI. To assess the quality of life (QOL), as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30, between the two arms (primary PRO). VII. To assess fatigue, as measured by Multidimensional Fatigue Inventory (MFI-20), between the two arms (secondary PRO). VIII. To determine if a subset of patients based on an optimal cutoff point of PD-L1 Combined Positive Score (CPS)/Tumour Proportion Score (TPS) is more likely to benefit in terms of PFS from adding nivolumab to platinum-gemcitabine as first-line treatment. EXPLORATORY OBJECTIVES:
I. To determine if a subset of patients based on an optimal cutoff point of PD-L1 CPS/TPS is more likely to benefit in terms of overall survival (OS) from adding nivolumab to platinum-gemcitabine as first-line treatment. II. To determine changes in QOL as measured by EORTC QLQ-C30 and in fatigue as measured by MFI-20, between and within arms over time (exploratory PRO). III. To collect blood and tissue specimens for future translational research. OUTLINE:

Patients are randomized to 1 of 2 arms. ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive gemcitabine and cisplatin or carboplatin as in Arm I. After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 3 years, and then annually.

Voir cet essai sur ClinicalTrials.gov

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