Safety, Pharmacokinetics (PK), and Efficacy of MK-1308 in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumours (MK-1308-001)

Titre officiel

A Phase 1 / 2 Open Label, Multi-Arm, Multicentre Study of MK-1308 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours

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
  • Coformulation Phase: Number of participants with ≥1 AE
  • Coformulation Phase: 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
  • Efficacy Expansion: Objective Response Rate (ORR) as assessed by blinded independent central review (BICR) based on modified Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
Secondary Outcome:
  • Dose Escalation: Area under the plasma concentration time curve (AUC) of MK-1308 at steady state
  • Dose Escalation: Minimum concentration (Cmin) of MK-1308 at steady state
  • Dose Escalation: Maximum concentration (Cmax) of MK-1308 at steady state
  • Dose Confirmation: AUC of MK-1308 at steady state
  • Dose Confirmation: Cmin of MK-1308 at steady state
  • Dose Confirmation: Cmax of MK-1308 at steady state
  • Dose Escalation, Dose Confirmation, and Coformulation: ORR as assessed by investigator based on modified RECIST 1.1
  • Efficacy Expansion: Duration of Response (DOR) as assessed by BICR based on modified RECIST 1.1
After screening, participants are assigned to either the Dose Escalation Phase or Dose Confirmation Phase. The Dose Escalation Phase consists of 3 cohorts and will evaluate available PK and safety data from the first 6 participants of each cohort, including dose limiting toxicities (DLTs). The purpose of the Dose Confirmation Phase is to gather additional safety, tolerability, PK, and preliminary efficacy data of MK-1308 in combination with pembrolizumab. The 5 arms of the Dose Confirmation Phase will include advanced/metastatic non-small cell lung cancer (NSCLC) and second line advanced/metastatic small cell lung cancer (SCLC). In participants who have initial evidence of radiological progressive disease (PD) by modified Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, it will be at the discretion of the investigator whether to continue a participant on study treatment until repeat imaging is obtained. Protocol Amendment 4 will enroll participants with melanoma in an Efficacy Expansion Cohort. During the Efficacy Expansion Phase, participants will be randomized to receive either MK-1308 in combination with pembrolizumab or MK-1308 monotherapy. Protocol Amendment 7 will enroll participants in a new cohort (Arm I). During the Coformulation Phase, the safety and PK of a coformulated product of MK-1308 plus pembrolizumab (MK-1308A) will be evaluated in comparison to that of the single, co-administered products given at the same dose and schedule.

Voir cet essai sur ClinicalTrials.gov

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