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A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

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A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Jul 2024

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At a glance

  • Drugs Cisplatin/vinblastine (Primary) ; Eribulin; Pazopanib; Trabectedin
  • Indications Leiomyosarcoma; Liposarcoma; Malignant fibrous histiocytoma; Soft tissue sarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms INVINCIBLE-3
  • Sponsors Intensity Therapeutics

    • Most Recent Events

    • 09 Jul 2024 According to an Intensity Therapeutics media release, company announces that the first U.S. patient has been dosed in the Phase 3 study to treat metastatic sarcoma. Company anticipates initiating sites in eight countries.
    • 19 Jun 2024 Status changed from not yet recruiting to recruiting.
    • 09 May 2024 According to an Intensity Therapeutics media release, company continues to qualify new sarcoma specialty hospitals in the US and internationally, and top enrolling centers from Intensity Therapeutics' previous metastatic study have expressed interest in participating in the INVINCIBLE-3 trial. Sites are being recruited and company continues to work towards initiating the study in mid-2024.
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