CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV)
compared to nivolumab monotherapy administered to participants with unresectable or
metastatic melanoma.
The study is divided into two phases: Phase 2 and Phase 3.
The primary objective of Phase 2 of the study is to determine confirmed objective response
rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus
nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of
first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects
with unresectable or metastatic melanoma.
The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS)
for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab
monotherapy for unresectable or metastatic melanoma.
The secondary objectives of Phase 3 are to:
- To evaluate the safety and tolerability of first-line CMP-001 in combination with
nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic
melanoma.
- To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus
nivolumab monotherapy in subjects with unresectable or metastatic melanoma.