At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 46 enrolled
Drug / intervention
Nivolumab +2 moredrug
Likely dose
Nivolumab 360 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 Phase II Clinical Trial of Combination Nivolumab (Opdivo), Ipilimumab (Yervoy), and Paclitaxel in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (The OPTIMAL Trial) [TOP 1705]
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 1 other intervention for Non-small Cell Lung Cancer. Completed, enrolled 46 participants across 1 site.
Detailed Summary
This is an open-label, non-randomized, phase II clinical research study designed to assess the safety and efficacy of nivolumab and ipilimumab in combination with paclitaxel in patients with treatment naïve NSCLC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartOct 2018
Primary CompletionMar 2023
Study CompletionJun 2023
TodayJul 2026
First PostedJun 29, 2018
Enrollment StartOct 2, 2018
Primary CompletionMar 12, 2023
Study CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.0 years ago
Interventions
Nivolumabdrug
360 mg intravenously every 3 weeks
Ipilimumabdrug
1 mg/kg intravenously over 30 minutes
Paclitaxeldrug
80 mg/m2 on days 1 and 8 of every 21-day treatment cycle