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CMP-001 and Nivolumab in Advanced Melanoma
NCT04695977Phase 3
Key facts
- Status
- Terminated
- Start
- Feb 2021
- Primary completion
- Jul 2024
- Countries
- 1
- Sponsor
- Regeneron Pharmaceuticals
- Modality
- Modified DNA Oligonucleotides, Single-strand DNA, Recombinant Protein Vaccines
- Drugs
- vidutolimod
- Conditions
- melanoma
01
Overview
Phase 3, randomised, open-label trial of vidutolimod in melanoma (2 arms), sponsored by Regeneron Pharmaceuticals. Primary endpoints: Confirmed Objective Response Rate at 39 months and Progression-free Survival at 39 months. Started Feb 2021; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
CMP-001 and Nivolumab
CMP-001 10 mg IT weekly for 7 doses then Q3W + Nivolumab 360 mg IV Q3W
Nivolumab Monotherapy
Nivolumab 360 mg IV Q3W
03
Who it enrols
Adults with unresectable Stage III or IV melanoma, ECOG 0-1, no prior systemic treatment for advanced disease, measurable disease amenable to intratumoral injection, and adequate organ function. Excludes uveal, acral, or mucosal melanoma, active infections, and significant cardiac or autoimmune diseases.
04
Endpoints
Primary
Confirmed Objective Response Rate
Progression-free Survival
Secondary
Treatment-emergent Adverse Events
Severity of Treatment-emergent Adverse Events
Time to Response
Duration of Response
Confirmed Objective Response Rate in Non-injected Target Lesions
Overall Survival
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