Trials / Terminated
TerminatedNCT04698187
CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
A Multicenter, Open-label, Phase 2 Study of Intratumoral CMP-001 in Combination With Intravenous Nivolumab in Subjects With Refractory Unresectable or Metastatic Melanoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Former Sponsor Checkmate Pharmaceuticals
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CMP-001 | Subjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W). |
| DRUG | Nivolumab | Nivolumab 360 mg IV is administered Q3W. |
Timeline
- Start date
- 2021-03-11
- Primary completion
- 2024-02-05
- Completion
- 2024-02-05
- First posted
- 2021-01-06
- Last updated
- 2025-06-11
- Results posted
- 2025-04-02
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04698187. Inclusion in this directory is not an endorsement.