Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumours (MK-1308-001)

Official Title

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

Summary:

This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumours.

Trial Description

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.

View this trial on ClinicalTrials.gov

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Resources

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