MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumours (MK-7684A-005)

Official Title

A Multicentre, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumours

Summary:

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumours. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
• Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
• ORR per RECIST 1.1 as Assessed by Investigator

• Overall Survival (OS)
• PFS per RECIST 1.1 as Assessed by Investigator
• Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
• DOR per RECIST 1.1 as Assessed by Investigator
• Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30)
• Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5)
• Number of Participants Who Experienced One or More Adverse Events (AEs)
• Number of Participants Who Discontinued Study Intervention Due to an AE

View this trial on ClinicalTrials.gov