Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Jun 30, 2026 to Apr 9, 2025
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Results first posted: Apr 22, 2025
    • Primary endpoint revised
    v8
  3. Primary completion date changed from estimate of Sep 13, 2024 to Sep 27, 2022
    • Study completion date: Sep 13, 2024 to Jun 30, 2026
    • Secondary endpoints revised (4)
    • Primary endpoint revised
    v7
  4. Primary completion date: Oct 31, 2023 to Sep 13, 2024v6 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 44 to confirmed 15
    • Study completion date: Oct 31, 2024 to Sep 13, 2024
    • Site details revised
  5. Site contact updatedv5
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  1. Primary completion date: Oct 31, 2021 to Oct 31, 2023
    • Study completion date: Oct 31, 2022 to Oct 31, 2024
    • Eligibility criteria expanded, about 25 words
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Oct 1, 2019 to Jun 5, 2019
    • Study description expanded, about 6 words
    • Site details revised
    • Eligibility criteria expanded, about 2 words
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Emory University
377 trials monitored
See 20 trials at risk
Melanoma
1,093 trials monitored
See 62 trials at risk
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.
Trial Details
NCT Number NCT03719131
Lead Sponsor Emory University
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 Cutaneous 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
Related terms Melanoma
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov