Calendario›REGN›CMP-001
CMP-001
CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
Ensayo de REGENERON PHARMACEUTICALS, INC. en Melanoma · Advanced Melanoma · Metastatic Melanoma · Unresectable Melanoma (del registro, en inglés).
Más ensayos de: Melanoma · Melanoma avanzado · Melanoma metastásico.
- Fase
- Fase 2/3
- Estado
- Interrumpido
- Participantes
- 20
- Centros
- 20
- Fin del objetivo primario
- jul 2024
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2021.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Business Decision».
Qué mide
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) (del registro, en inglés) (hasta unos 39 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroCMP-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.
Más ensayos de REGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| cemiplimab | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Pozelimab + Cemdisiran · NIMBLE | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Garetosmab · OPTIMA | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Aflibercept 8 mg · ELARA | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| Dupilumab · ENGAGE | Fase 2 | En marcha, sin reclutar | feb 2026 (real) |
| Fianlimab | Fase 3 | En marcha, sin reclutar | mar 2026 (real) |
Todos los de REGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04695977), actualizada en may 2026.