Study of MK-4280 as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy AND MK-4280A as Monotherapy in Adults With Advanced Solid Tumours (MK-4280-001)

Official Title

A Phase 1 Trial of MK-4280 as Monotherapy and in Combination With Pembrolizumab With or Without Chemotherapy in Subjects With Advanced Solid Tumours

Summary:

This is a safety and pharmacokinetics study of MK-4280 as monotherapy and in combination with pembrolizumab (MK-3475) AND MK-4280A as monotherapy in adults with metastatic solid tumours for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive MK-4280 as monotherapy or MK-4280 in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RPTD), as determined by dose-limiting toxicity, for MK-4280 in combination with pembrolizumab in participants with advanced solid tumours. Part B will also assess the efficacy of MK-4280 as monotherapy and in combination with pembrolizumab with and without chemotherapy AND MK-4280A as monotherapy in expansion cohorts.

Trial Description

Primary Outcome:

  • Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
  • Number of Participants Who Experience at Least One Adverse Event (AE)
  • Number of Participants Who Discontinue Study Drug Due to an AE
Secondary Outcome:
  • Objective Response Rate (ORR) as Determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1) as Assessed by Investigator Review of MK-4280 in Combination With Pembrolizumab
  • ORR as Determined by RECIST 1.1 as Assessed by Investigator Review of Two Doses of MK-4280 in Combination With Pembrolizumab for Participants with Advanced Solid Tumours in Cohort E
  • ORR as Determined by RECIST 1.1 as Assessed by Investigator Review of MK-4280 in Combination With Pembrolizumab and mFOLFOX7 for Participants with Advanced Solid Tumours in Cohort B
  • ORR as Determined by RECIST 1.1 as Assessed by Investigator Review of MK-4280 in Combination With Pembrolizumab and FOLFIRI for Participants with Advanced Solid Tumours in Cohort B
  • Serum Concentration of MK-4280 When Administered as Monotherapy
  • Serum Concentration of MK-4280 When Administered in Combination With Pembrolizumab
  • Serum Concentration of MK-4280 When Administered in Combination With Pembrolizumab and mFOLFOX7
  • Serum Concentration of MK-4280 When Administered in Combination With Pembrolizumab and FOLFIRI
  • At designated time points (Up to approximately 2 years)
  • Serum Concentration of Pembrolizumab When Administered in Combination With MK-4280 and mFOLFOX7
  • Serum Concentration of Pembrolizumab When Administered in Combination With MK-4280 and FOLFIRI
  • Serum Concentration of MK-4280 When Administered as a Co-Formulation With Pembrolizumab (MK-4280A)
  • Serum Concentration of MK-4280 When Administered Sequentially With Pembrolizumab
  • Serum Concentration of Pembrolizumab When Administered as a Co-Formulation With MK-4280 (MK-4280A)
  • Serum Concentration of Pembrolizumab When Administered Sequentially With MK-4280

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society