At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 196 enrolled
Drug / intervention
PDR001 +4 moredrug
Likely dose
PDR001 400 mgfrom 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 II Open Platform Study Evaluating the Efficacy and Safety of Novel Spartalizumab (PDR001) Combinations in Previously Treated Unresectable or Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating PDR001, LAG525, and 3 other interventions for Melanoma. Completed, enrolled 196 participants across 30 sites in 10 countries.
Detailed Summary
The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesAustralia, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartSep 2018
Primary CompletionDec 2022
TodayJul 2026
First PostedApr 2, 2018
Enrollment StartSep 10, 2018
Primary CompletionDec 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 8.3 years ago
Interventions
PDR001drug
400 mg of PDR001 administered every 4 weeks intravenously
LAG525drug
600 mg of LAG525 administered every 4 weeks intravenously
INC280drug
400 mg of INC280 administered twice daily orally
ACZ885drug
200 mg of ACZ885 administered every 4 weeks subcutaneosuly
LEE011drug
600 mg of LEE011 orally taken once daily on Days 1-21 of a 28-day cycle