An Open-Label, Phase 1b, Multi-Arm Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Patients With Advanced Melanoma

Trial Profile

An Open-Label, Phase 1b, Multi-Arm Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Patients With Advanced Melanoma

Recruiting
Phase of Trial: Phase I

Latest Information Update: 04 Jun 2017

At a glance

  • Drugs Plozalizumab (Primary) ; TAK 580 (Primary) ; Vedolizumab (Primary) ; Ipilimumab; Nivolumab
  • Indications Malignant melanoma
  • Focus Adverse reactions
  • Sponsors Takeda Oncology
  • Most Recent Events

    • 02 Feb 2017 The time frame of primary endpoint has been changed from 30 days after last dose of study drug to 30, 60, and 90 days after last dose of study drug and different timeframe has added for different combination of drug i.e Baseline up to Week 9 for TAK-580 + nivolumab and TAK-202 (plozalizumab) + nivolumab; Baseline up to Week 7 for vedolizumab + nivolumab + ipilimumab.
    • 25 Oct 2016 Planned End Date changed from 1 Sep 2018 to 1 Nov 2018.
    • 25 Oct 2016 Planned primary completion date changed from 1 Sep 2018 to 1 Nov 2018.
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