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 [IGNYTE]
Status:
Active, no longer recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 19 Aug 2026
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
- 07 Aug 2026 According to a Replimune media release, results from the trial were published in the Journal of Clinical Oncology
- 06 Aug 2026 According to a Food and Drug Administration media release, the U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) for the treatment of advanced, refractory melanoma. Tudriqev is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
- 31 Jul 2026 According to a Replimune media release, company announced the outcome of the U.S. Food and Drug Administrations (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) meeting, which discussed the Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.