At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 212 enrolled
Drug / intervention
Nivolumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
In Brief
A Phase 2 clinical trial evaluating Nivolumab and Ipilimumab for Pan Tumor. Completed, enrolled 212 participants across 60 sites in 17 countries.
Detailed Summary
The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPan Tumor
CountriesArgentina, Australia, Belgium, Canada, Chile, Denmark, France, Germany, Italy, Netherlands, Poland, Puerto Rico, Romania, Singapore, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartOct 2018
Primary CompletionMay 2022
Study CompletionAug 2023
TodayJul 2026
First PostedSep 12, 2018
Enrollment StartOct 31, 2018
Primary CompletionMay 3, 2022
Study CompletionAug 2, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.8 years ago
Interventions
Nivolumabbiological
Specified dose on specified days
Ipilimumabbiological
Specified dose on specified days