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: 27 Aug 2025
Price :
$35
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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
- 31 Jul 2025 According to a Replimune media release, the lawsuit is focused on the propriety of Replimunes statements concerning data submitted to the FDA in support of its Biologics License Application (BLA).
- 22 Jul 2025 According to a Replimune media release, FDA has indicated IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. The FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components.
- 22 Jul 2025 According to a Replimune media release, U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The Company will request a Type A meeting and expects it will be granted within 30 days. Replimune plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1.