Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (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 or Lenvatinib (E7080/MK-7902) in Subjects With Advanced Solid Tumours

Summary:

This is a safety and pharmacokinetics study of favezelimab as monotherapy and in combination with pembrolizumab AND favezelimab/pembrolizumab 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 favezelimab as monotherapy or favezelimab in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RP2D), as determined by dose-limiting toxicity, for favezelimab in combination with pembrolizumab or pembrolizumab and lenvatinib in participants with advanced solid tumours. Part B will also assess the efficacy of favezelimab as monotherapy; favezelimab in combination with pembrolizumab with and without chemotherapy; favezelimab in combination with pembrolizumab and lenvatinib; and favezelimab/pembrolizumab as monotherapy in expansion cohorts. Participants who have completed the initial course of treatment and have investigator-determined progressive disease may be eligible for a second course of an additional 17 cycles of study treatment.

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

• Serum Concentration of Favezelimab When Administered as Monotherapy
• Serum Concentration of Favezelimab When Administered in Combination With Pembrolizumab
• Serum Concentration of Favezelimab When Administered in Combination With Pembrolizumab and mFOLFOX7
• Serum Concentration of Favezelimab When Administered in Combination With Pembrolizumab and FOLFIRI
• Serum Concentration of Favezelimab When Administered in Combination With Pembrolizumab and Lenvatinib
• Serum Concentration of Pembrolizumab When Administered in Combination With Favezelimab and mFOLFOX7
• Serum Concentration of Pembrolizumab When Administered in Combination With Favezelimab and FOLFIRI
• Serum Concentration of Pembrolizumab When Administered in Combination With Favezelimab and Lenvatinib
• Serum Concentration of Lenvatinib When Administered in Combination With Pembrolizumab and Favezelimab
• Objective Response Rate (ORR) as Determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1) as Assessed by Investigator Review of Favezelimab Alone and in Combination With Pembrolizumab
• ORR as Determined by RECIST 1.1 as Assessed by Investigator Review of Two Doses of Favezelimab 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 Favezelimab 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 Favezelimab in Combination With Pembrolizumab and FOLFIRI for Participants With Advanced Solid Tumours in Cohort B
• ORR as Determined by RECIST 1.1 as Assessed by Investigator Review of Favezelimab in Combination With Pembrolizumab and Lenvatinib for Participants With Advanced Solid Tumours in Cohort G
• Serum Concentration of Favezelimab When Administered as a Co-Formulation With Pembrolizumab (MK-4280A)
• Serum Concentration of Favezelimab When Administered Sequentially With Pembrolizumab
• Serum Concentration of Pembrolizumab When Administered as a Co-Formulation With Favezelimab (MK-4280A)
• Serum Concentration of Pembrolizumab When Administered Sequentially With Favezelimab

View this trial on ClinicalTrials.gov