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A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Cemiplimab (Anti-PD-1) and Other Agents in Japanese Patients With Advanced Malignancies

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Trial Profile

A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Cemiplimab (Anti-PD-1) and Other Agents in Japanese Patients With Advanced Malignancies

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Nov 2023

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At a glance

  • Drugs Cemiplimab (Primary) ; Fianlimab (Primary) ; Gemcitabine; Ipilimumab; Paclitaxel; Pemetrexed
  • Indications Advanced breast cancer; Bladder cancer; Lung cancer; Malignant melanoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Solid tumours; Uterine cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 14 Sep 2023 Planned number of patients changed from 117 to 145.
    • 14 Sep 2023 Planned End Date changed from 24 May 2026 to 27 Mar 2030.
    • 14 Sep 2023 Planned primary completion date changed from 24 May 2026 to 22 Dec 2027.
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