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A Phase 1, Open Label, Dose-Escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

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Trial Profile

A Phase 1, Open Label, Dose-Escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Jan 2023

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At a glance

  • Drugs Nivolumab (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Malignant melanoma; Non-small cell lung cancer; Prostate cancer; Renal cell carcinoma
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Bristol-Myers Squibb; Medarex

    • Most Recent Events

    • 28 Jan 2023 Results assessing safety and tolerability of anti-PD-1 blockade in patients with treatment-refractory solid tumors and to preliminarily assess antitumor activity, pharmacodynamics, and immunologic correlates published in the Journal of Clinical Oncology
    • 22 May 2019 Results of Model-Based Population Pharmacokinetic Analysis of Nivolumab in Chinese Patients using data from 2 predominantly Chinese and 5 global studies, published in the Journal of Clinical Pharmacology
    • 15 May 2019 Results of PPK analysis using data from multiple clinical studies in patients with AdjMEL, MEL, NSCLC, and other tumor types (CA209-001, CA209-003, CA209-005, CA209-017, CA209-057, CA209-037, CA209-066, CA209-238, CA209-063 and CA209-051) published in the Clinical Pharmacology and Therapeutics

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