At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 886 enrolled
Drug / intervention
Avelumab (MSB0010718C) +2 moredrug
Likely dose
Avelumab (MSB0010718C) 10 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.
A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
In Brief
A Phase 3 clinical trial evaluating Avelumab (MSB0010718C), Axitinib (AG-013736), and 1 other intervention for Renal Cell Cancer. Completed, enrolled 886 participants across 270 sites in 21 countries.
Detailed Summary
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Cancer
CountriesAustralia, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Romania, Russia, South Korea, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionAug 2023
Study CompletionJun 2024
TodayJul 2026
First PostedFeb 17, 2016
Enrollment StartMar 23, 2016
Primary CompletionAug 31, 2023
Study CompletionJun 26, 2024
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 10.4 years ago
Interventions
Avelumab (MSB0010718C)drug
IV treatment Avelumab administered at 10 mg/kg IV every two weeks
Axitinib (AG-013736)drug
Oral treatment Axitinib given 5 mg PO BID
Sunitinibdrug
Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2