At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
Regorafenib +1 moredrug
Likely dose
Nivolumab 3.0 mg/kgfrom 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.
Regorafenib and Nivolumab Simultaneous Combination Therapy for Advanced and Metastatic Solid Tumors: Phase I Clinical Trial
In Brief
A Phase 1 clinical trial evaluating Regorafenib and Nivolumab for Advanced and Metastatic Solid Tumor. Completed, enrolled 50 participants across 1 site.
Detailed Summary
the efficacy and safety ofhe use of regorafenib in combination with nivolumab
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced and Metastatic Solid Tumor
CountriesJapan
CollaboratorsOno Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd.
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedJan 2018
Primary CompletionDec 2020
TodayJul 2026
First PostedJan 23, 2018
Enrollment StartJan 15, 2018
Primary CompletionDec 15, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.4 years ago
Interventions
Regorafenibdrug
One course will last 28 days. Oral administration for 21 consecutive days, with a 1-week washout period. As for the expansion cohort, implemented using the RD estimated in the dose-escalation cohort.
Nivolumabdrug
One course will last 28 days. Given once every 2 weeks at a dose of 3.0 mg/kg.