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Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors

StatusTerminated
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: Drug unavailable Results posted: Sep 16, 2026 · Primary completion date changed from estimate of May 1, 2028 to Jul 15, 2025 · Eligibility criteria expanded, about 38 words · 2 more Show 5 more changesShow less
    • Results posted: Sep 16, 2026
    • Primary completion date changed from estimate of May 1, 2028 to Jul 15, 2025
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
  2. Secondary endpoints: details revised at 4 of 4 entriesv8
  3. Trial status: Active, Not Recruiting to Terminated Sponsor's reason: Drug unavailable Primary completion date changed from estimate of May 1, 2028 to Jul 15, 2025 · Study completion date changed from estimate of May 1, 2029 to Mar 13, 2026 · Secondary endpoints: 3 to 4 · 1 morev7 Show 4 more changesShow less
    • Primary completion date changed from estimate of May 1, 2028 to Jul 15, 2025
    • Study completion date changed from estimate of May 1, 2029 to Mar 13, 2026
    • Secondary endpoints: 3 to 4
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Suspended to Active, Not Recruiting Enrollment target: estimated 29 to confirmed 7v6 Show 1 more changeShow less
    • Enrollment target: estimated 29 to confirmed 7
  5. Trial status: Recruiting to Suspended Sponsor's reason: Drug unavailable Site details revisedv5 Show 1 more changeShow less
    • Site details revised
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Start date changed from estimate of Apr 30, 2023 to May 9, 2023v3
  3. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This phase II clinical trial tests how well rigosertib plus pembrolizumab workings in treating patients with melanoma which cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic), and that has not responded to previous treatment with PD-1 or PD-L1 inhibitors (refractory). Rigosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may change the immune system to make immunotherapy more effective. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving rigosertib in combination with pembrolizumab may be more effective in treating patients with unresectable metastatic melanoma that has not responded to previous treatment with PD-1 or PD-L1 inhibitors than giving either drug alone.
Trial Details
NCT Number NCT05764395
Lead Sponsor Vanderbilt-Ingram Cancer Center
Conditions Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Refractory Melanoma, Unresectable Melanoma
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov