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A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

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Trial Profile

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 May 2024

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At a glance

  • Drugs Tisotumab-vedotin (Primary) ; Gemcitabine; Irinotecan; Pemetrexed; Topotecan; Vinorelbine
  • Indications Adenocarcinoma; Adenosquamous carcinoma; Cervical cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms innovaTV 301
  • Sponsors Pfizer; Seagen
  • Most Recent Events

    • 30 Apr 2024 According to Pfizer media release, the Food and Drug Administration (US FDA) granted supplemental Biologics License Application (sBLA) approval to TIVDAK (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.The approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial
    • 27 Feb 2024 According to a ZAI Lab media release, the company to submit an NDA to the NMPA in second-line+ cervical cancer.
    • 05 Feb 2024 Last checked against European Clinical Trials Database record.
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