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An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

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Trial Profile

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Dec 2023

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At a glance

  • Drugs Nivolumab (Primary) ; Vusolimogene oderparepvec (Primary)
  • Indications Basal cell cancer; Bladder cancer; Carcinoma; Haemangiosarcoma; Head and neck cancer; Malignant melanoma; Merkel cell carcinoma; Non-small cell lung cancer; Skin cancer; Solid tumours; Squamous cell cancer; Urogenital cancer; Uveal melanoma
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms IGNYTE
  • Sponsors Replimune

    • Most Recent Events

    • 05 Dec 2023 According to a Replimune media release, The company recently participated in a Type C meeting with the U.S. Food and Drug Administration (FDA) and FDA acknowledged that the anti-PD1 failed melanoma population is one of unmet need. The FDA agreed with an anti-PD1 failed melanoma confirmatory study design concept consisting of a 2-arm randomized trial with physician's choice of treatment as a comparator arm in the study population. Full protocol development is currently underway.
    • 05 Dec 2023 According to a Replimune media release, BLA submission is expected in 2H 2024.
    • 05 Dec 2023 Initial data for all patients in the anti-PD1 failed melanoma cohort presented in the Replimune Media Release.
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