At a glance
ClinicalIndex Comparison RecordPhase 2Active· 15 enrolled
Drug / intervention
Nivolumab +2 moredrug
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 Randomized Phase 2 Study of Rituxan Hycela in Patients With Advanced Melanoma Undergoing Combination Immune Checkpoint Blockade With Nivolumab and Ipilimumab
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Rituximab and Hyaluronidase Human, and 1 other intervention for Cutaneous Melanoma, Stage III and 7 related conditions. Active but no longer recruiting, targeting 15 participants across 1 site.
Detailed Summary
This phase II trial studies whether rituximab and hyaluronidase human (Rituxan Hycela) can prevent immune related adverse events in participants with stage III-IV melanoma that cannot be removed by surgery who are undergoing nivolumab and ipilimumab therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV, Stage III Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage IV Skin Melanoma, Unresectable Melanoma
CountriesUnited States
CollaboratorsGenentech, Inc.
Timeline
Phase 2ActiveOverdue
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartJun 2019
Primary CompletionSep 2022
Study CompletionJun 2026
TodayJul 2026
First PostedOct 25, 2018
Enrollment StartJun 5, 2019
Primary CompletionSep 27, 2022
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.7 years ago
Interventions
Nivolumabdrug
Receive standard of care nivolumab therapy
Rituximab and Hyaluronidase Humanbiological
Given IV or SC
Ipilimumabdrug
Receive standard of care ipilimumab therapy