Calendario›XCUR›Cavrotolimod

Cavrotolimod

Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors

Ensayo de EXICURE, INC. en Advanced or Metastatic Merkel Cell Carcinoma · Advanced or Metastatic Cutaneous Squamous Cell Carcinoma · Advanced or Metastatic Melanoma · Advanced or Metastatic Head and Neck Squamous Cell Carcinoma · Advanced or Metastatic Solid Tumors (del registro, en inglés).

Más ensayos de: Tumor sólido avanzado o metastásico.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

57

previstos

Centros

26

Fin del objetivo primario

mar 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en dic 2018.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was canceled for administrative reasons.».

Qué mide

Adverse events of cavrotolimod alone and in combination with pembrolizumab or cemiplimab (Study day 36) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a phase 1b/2, open-label, two-part, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with Merkel Cell Carcinoma, cutaneous squamous cell carcinoma, and advanced solid tumors. Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of cavrotolimod given with a fixed dose of pembrolizumab. The Phase 2 dose expansion part of the study will consist of two primary cohorts of patients: Merkel cell carcinoma and cutaneous squamous cell carcinoma. Patients in the Merkel Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of pembrolizumab while the Cutaneous Squamous Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI.

Más ensayos de XCUR

Todos los de XCUR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03684785), actualizada en mar 2022.