drugset / Trial / NCT04698187

CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma

NCT04698187

NaSingle-groupOpen-labelTreatment

Summary

CMP-001-010 is a Phase 2 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) administered to participants with refractory unresectable or metastatic melanoma. The primary objective of the study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. The secondary objectives are to: * To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. * To evaluate the efficacy of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. * To assess the pharmacokinetic (PK) profile of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. * To assess and describe the immunogenicity of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.

Timeline

Start
2021-03-11
Primary completion
2024-02-05
Completion
2024-02-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 360 mg Intravenous
Subject Vidutolimod Other / unclassified 10 mg Other

Indications