An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

Official Title

A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers

Summary:

The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.

Trial Description

Primary Outcome:

• Incidence of dose limiting toxicity (DLTs)
• Incidence of Adverse Events (AEs)
• Incidence of Serious Adverse Events (SAEs)
• Incidence of Deaths
• Incidence of clinically significant changes in clinical laboratory results: Hematology tests
• Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
• Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
• Objective response rate (ORR) by investigator (Part 1B and Part 2)

• Objective response rate (ORR) (Part 1A and Part 1)
• Disease control rate (DCR)
• Duration of response (DOR)
• Time to response (TTR)
• Progression-free survival (PFS) by investigator per response evaluation criteria in solid tumours (RECIST) v1.1
• Best overall response (BOR)
• Overall survival (OS)
• Incidence of Adverse Events (AEs)
• Incidence of Serious Adverse Events (SAEs)
• Incidence of Deaths
• Incidence of clinically significant changes in clinical laboratory results: Hematology tests
• Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
• Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

View this trial on ClinicalTrials.gov