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A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

Trial Profile

A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Aug 2019

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At a glance

  • Drugs Nivolumab (Primary) ; Relatlimab (Primary) ; Nivolumab/relatlimab
  • Indications Bladder cancer; Cervical cancer; Colorectal cancer; Gastric cancer; Head and neck cancer; Liver cancer; Malignant melanoma; Non-small cell lung cancer; Ovarian cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 04 Jun 2019 Planned End Date changed from 18 Dec 2020 to 31 Dec 2023.
    • 04 Jun 2019 Planned primary completion date changed from 28 Aug 2020 to 31 Dec 2023.
    • 16 Mar 2019 Results assessing the PK of relatlimab and identify the potential effect of covariates on relatlimab exposure using pooled data from CA224- 020 and CA224- 022 studies, presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
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