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A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients

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Trial Profile

A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients

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

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs Bifikafusp alfa/onfekafusp alfa (Primary)
  • Indications Cancer metastases; Malignant melanoma; Skin cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PIVOTAL
  • Sponsors Philogen

Most Recent Events

  • 13 Sep 2024 Planned End Date changed from 1 Dec 2025 to 1 Dec 2028.
  • 04 Jul 2024 According to a Sun Pharmaceutical Industries media release, the data of this trial are expected to be published in a peer-reviewed scientific journal in 2024.
  • 04 Jul 2024 According to a Sun Pharmaceutical Industries media release, on June 20th the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy.

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