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A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer

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A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Feb 2024

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At a glance

  • Drugs Nivolumab (Primary) ; Trastuzumab-deruxtecan (Primary)
  • Indications Advanced breast cancer; Bladder cancer; Carcinoma; Urogenital cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Daiichi Sankyo Company

    • Most Recent Events

    • 19 Feb 2022 Primary analysis (data cutoff (July 22, 2021; n=34) presented at the 2022 Genitourinary Cancers Symposium
    • 19 Jul 2021 Planned End Date changed from 1 Jun 2021 to 1 Jul 2022.
    • 19 Jul 2021 Planned primary completion date changed from 1 Jun 2021 to 22 Jul 2021.

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