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
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
- 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.