At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 182 enrolled
Drug / intervention
Nivolumab +4 morebiological
Likely dose
Not stated in record
Key inclusion· 4
- ✓Diagnosis of advanced renal cell carcinoma
- ✓At least 1 measurable lesion
- ✓Karnofsky Performance Status ≥70%
- ✓Life expectancy of at least 3 months
Key exclusion· 3
- ✕Untreated CNS metastases (treated/stable metastases may be allowed)
- ✕Autoimmune disease
- ✕Requirement for daily oxygen therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 3 other interventions for Advanced Cancer. Completed, enrolled 182 participants across 32 sites in 6 countries.
Detailed Summary
The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer
CountriesAustralia, Austria, Canada, Israel, Italy, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartFeb 2017
Primary CompletionNov 2021
TodayJul 2026
First PostedDec 19, 2016
Enrollment StartFeb 2, 2017
Primary CompletionNov 23, 2021
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.5 years ago
Interventions
Nivolumabbiological
Specified Dose on Specified Days
Ipilimumabbiological
Specified Dose on Specified Days
Relatlimabbiological
Specified Dose on Specified Days
BMS-986205drug
Specified Dose on Specified Days
BMS-813160drug
Specified Dose on Specified Days