MelanomaOpen to EnrollmentPhase 3

MELANOMA: METASTATIC: POST-ipi/nivo: Injectable: RP1-104: IGNYTE-3

Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment

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Study snapshot

Title: Replimune RP1-104 melanoma post ipi/nivo
Malignancy: Melanoma
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 2nd line
Investigational agent: RP1 (vusolimogene oderparepvec)
Drug class: Oncolytic immunotherapy
Principal investigator: David Portnoy, MD
Sponsor: Replimmune Inc.
Path: Cutaneous melanoma
Randomized: Yes
ClinicalTrials.gov ID: NCT06264180

Eligibility and objectives

Key eligibility criteria details

Histologically or cytologically confirmed unresectable or metastatic Stage IIIB through IV M1a through M1d cutaneous melanoma
Confirmed disease progression on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen or in sequence
Documented BRAF mutation status. Those with BRAF mutation should have received BRAF/MEK therapy unless contraindicated
Measurable and injectable disease (>1cm)
ECOG PS 0-1
No primary mucosal or uveal melanoma
No more than 2 lines of prior systemic therapy for metastatic disease
No known HIV
No LDH .2x ULN
No need for intermittend or chronic use of anti-viral therapy

Objective

Primary
- OS
Secondary
- PFS
- ORR

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details