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An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients

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Trial Profile

An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Bifikafusp alfa/onfekafusp alfa (Primary) ; Ipilimumab
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms NeoDREAM
  • Sponsors Philogen

Most Recent Events

  • 28 Mar 2023 According to a Philogen media release, patient enrolment in the US Phase III study in Stage IIIB/C melanoma continues in line with company plans. As of the date of this press release, 30 centres have been opened (19 in 2022, 5 in 2023). Additional centres will be opened during 2023.
  • 20 Dec 2021 Planned End Date changed from 1 Dec 2024 to 1 Jun 2026.
  • 20 Dec 2021 Planned primary completion date changed from 1 Jun 2023 to 1 Jun 2024.

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