A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumours of High Tumour Mutational Burden (TMB-H)

Official Title

A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumours of High Tumour Mutational Burden (TMB-H)

Summary:

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumours with High Tumour Mutational Burden (TMB-H)

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) in the Tissue Tumour Mutational Burden (tTMB-H) Population
• Objective Response Rate (ORR) in the Blood Tumour Mutational Burden (bTMB-H) Population

• Duration of response (DOR)
• Objective Response Rate (ORR)
• Time To Response (TTR)
• Clinical benefit rate (CBR)
• Overall survival (OS)
• Progression Free Survival (PFS)
• Incidence of Adverse Events (AEs)
• Incidence of Serious Adverse Events (SAEs)
• Incidence of AEs leading to discontinuation
• Incidence of Deaths
• Incidence of laboratory abnormalities
• Incidence of anti-drug antibody (ADA)

View this trial on ClinicalTrials.gov