Calendario›REGN›CMP-001

CMP-001

Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Participants With Advanced Melanoma

Ensayo de REGENERON PHARMACEUTICALS, INC. en Melanoma maligno.

Más ensayos de: Melanoma maligno.

Fase

Fase 1

Estado

Completado

Participantes

30

previstos

Centros

4

Fin del objetivo primario

jul 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2017.

Qué mide

Part 1: Dose-Escalation Phase: RP2D of CMP-001 When Administered SC and Given in Combination With Pembrolizumab (15 days from date of first CMP-001 injection (Week 1 Day 1)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroCMP-001-002 is a Phase 1b study of CMP-001 administered to participants with advanced melanoma who are either receiving pembrolizumab, or who have previously received an anti-programmed cell death protein 1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) therapy for advanced melanoma, and who have not responded (that is, immunotherapy resistant). This study will be conducted in two parts: Part 1 will consist of a Dose Escalation Phase and a Dose Expansion Phase * Dose Escalation Phase will be conducted to assess and identify a recommended phase 2 dose (RP2D) of CMP-001 for subcutaneous (SC) administration * The Dose Expansion Phase is intended to further characterize the safety, pharmacodynamics, and preliminary evidence of antitumor activity of the RP2D of CMP-001 administered SC in combination with pembrolizumab Part 2 will assess the safety and preliminary evidence of antitumor activity of CMP-001, administered both SC and intratumoral (IT) when given in combination with pembrolizumab. Participants will continue treatment with CMP-001 in combination with pembrolizumab as long as they do not experience unacceptable toxicities and when continued treatment, is in the participant's best interest according to the Investigator.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03084640), actualizada en ago 2022.