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A Phase 2, Three-arm, Randomized Study of the Efficacy of Intratumorally Administered L19IL2 or L19TNF or L19IL2/L19TNF, All in Combination With Systemic Anti-PD1 Pembrolizumab, in Stage III and IV Unresectable Melanoma Patients With Resistance to or Progressing Upon Anti-PD1 Checkpoint Inhibitors and With Presence of Injectable Metastases

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Trial Profile

A Phase 2, Three-arm, Randomized Study of the Efficacy of Intratumorally Administered L19IL2 or L19TNF or L19IL2/L19TNF, All in Combination With Systemic Anti-PD1 Pembrolizumab, in Stage III and IV Unresectable Melanoma Patients With Resistance to or Progressing Upon Anti-PD1 Checkpoint Inhibitors and With Presence of Injectable Metastases

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Oct 2024

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At a glance

  • Drugs Bifikafusp alfa (Primary) ; Bifikafusp alfa/onfekafusp alfa (Primary) ; Onfekafusp alfa (Primary) ; Pembrolizumab (Primary)
  • Indications Malignant melanoma
  • Focus Therapeutic Use
  • Sponsors Philogen

Most Recent Events

  • 26 Oct 2024 Status changed from active, no longer recruiting to recruiting.
  • 06 Jun 2023 New trial record
  • 01 Jun 2023 According to a Philogen media release, company entered into a Clinical Trial Collaboration and Supply Agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA). Under the terms of the supply agreement, MSD provides their anti-PD-1 therapy, KEYTRUDA (pembrolizumab), to be evaluated in combination with Philogen's immunocytokines L19IL2, L19TNF, and Nidleg in a randomized Phase II clinical trial.

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