Innocuité, pharmacocinétique et efficacité du MK-1308 en association avec le pembrolizumab (MK-3475) dans le traitement de tumeurs solides au stade avancé (MK-1308-001)

Titre officiel

Étude ouverte de phase I/II multicentrique à multiples groupes évaluant le MK-1308 en association avec le pembrolizumab chez des sujets atteints de tumeurs solides au stade avancé

Sommaire:

Cette étude évaluera l’innocuité, la tolérabilité, la pharmacocinétique (PK) et l’efficacité préliminaire de doses croissantes de MK-1308 lorsqu’il est utilisé en association avec le pembrolizumab chez des participants atteints de tumeurs solides à un stade avancé.

Description de l'essai

Primary Outcome:

  • Number of participants with a Dose Limiting Toxicity (DLT)
  • Number of participants with ≥1 adverse event (AE)
  • Number of participants discontinuing study treatment due to an AE
  • Efficacy Expansion: Number of participants with ≥1 AE
  • Efficacy Expansion: Number of participants discontinuing study treatment due to an AE
  • Coformulation: Number of participants with ≥1 DLT
  • Coformulation: Number of participants with ≥1 AE
  • Coformulation: Number of participants discontinuing study treatment due to an AE
  • Efficacy Expansion and Coformulation: Objective Response Rate (ORR) as assessed by blinded independent central review (BICR) based on adjusted Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
Secondary Outcome:
  • Area under the plasma concentration time curve (AUC) of pembrolizumab
  • Maximum concentration (Cmax) of pembrolizumab
  • Minimum concentration (Cmin) of pembrolizumab
  • Number of participants with pembrolizumab anti-drug antibodies (ADAs)
  • AUC of quavonlimab
  • Cmax of quavonlimab
  • Cmin of quavonlimab
  • Number of participants with quavonlimab ADAs
  • Chinese Cohort: AUC of pembrolizumab
  • Chinese Cohort: Cmax of pembrolizumab
  • Chinese Cohort: Cmin of pembrolizumab
  • Chinese Cohort: Number of participants with pembrolizumab ADAs
  • Chinese Cohort: AUC of quavonlimab
  • Chinese Cohort: Cmax of quavonlimab
  • Chinese Cohort: Cmin of quavonlimab
  • Chinese Cohort: Number of participants with quavonlimab ADAs
  • Dose Escalation, Dose Confirmation, Coformulation: ORR as assessed by investigator based on adjusted RECIST v1.1
  • Efficacy Expansion and Coformulation: Duration of Response (DOR) as assessed by BICR based on adjusted RECIST v1.1
After screening, participants will be assigned to the Dose Escalation, Dose Confirmation, Efficacy Expansion, or Coformulation Phase. The Dose Escalation Phase will evaluate available PK and safety data including dose limiting toxicities (DLTs). The Dose Confirmation Phase will gather additional safety, tolerability, PK, and preliminary efficacy data of quavonlimab in combination with pembrolizumab, and will include first-line advanced/metastatic non-small cell lung cancer (NSCLC) and second line (and beyond) advanced/metastatic small cell lung cancer (SCLC). The purpose of the Efficacy Expansion Phase is to gather preliminary anti-tumour efficacy data for quavonlimab in combination with pembrolizumab as well as for quavonlimab monotherapy in the specific target population of programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma. The Coformulation Phase will evaluate the safety and PK of a coformulated product of pembrolizumab/quavonlimab (MK-1308A) in comparison to that of the single, co-administered products given at the same dose and schedule, and include participants with advanced solid tumours, PD-1/L1 refractory advanced melanoma, and participants from mainland China.

Voir cet essai sur ClinicalTrials.gov

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