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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: 12 Aug 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

    • 08 Aug 2024 According to an Intensity Therapeutics media release, company has screened and qualified over 50 sites for the INVINCIBLE-3 Study. Contract negotiations are in process to approve and activate these sites, which is estimated to take up to six months per site.
    • 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.

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