At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 94 enrolled
Drug / intervention
Ipilimumab +1 morebiological
Likely dose
Not stated in 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 Randomized Study of Nivolumab (NSC-748726) With Ipilimumab (NSC-732442) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD1 or Anti-PD-L1 Agent
In Brief
A Phase 2 clinical trial evaluating Ipilimumab and Nivolumab for Clinical Stage III Cutaneous Melanoma AJCC v8 and 5 related conditions. Completed, enrolled 94 participants across 638 sites.
Detailed Summary
This phase II trial studies how well ipilimumab with or without nivolumab work in treating patients with melanoma that is stage IV or stage III and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Melanoma of Unknown Primary, Mucosal Melanoma, Unresectable Cutaneous Melanoma, Unresectable Melanoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartOct 2017
Primary CompletionSep 2023
Study CompletionMar 2024
TodayJul 2026
First PostedJan 27, 2017
Enrollment StartOct 23, 2017
Primary CompletionSep 19, 2023
Study CompletionMar 20, 2024
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 9.4 years ago
Interventions
Ipilimumabbiological
Given IV
Nivolumabbiological
Given IV