A Phase 3 Randomized, Double-blind, Multicenter, Global S... | EligiMed

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04590963Tipo: INTERVENTIONALInicio: 2 de oct de 2020Fin estimado: 24 de sept de 2026

Traducción no disponible, mostrando original

Resumen

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer

Descripción detallada

Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Participants in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All Participants will be followed for survival after progression is confirmed.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Are aged 18 years and over
Recurrent or metastatic squamous cell carcinoma of the SCCHN, oral cavity, oropharynx, hypopharynx, or larynx which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy
Received prior treatment using a programmed cell death ligand-1 (PD-L1) inhibitor
Prior platinum failure
Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
Has measurable disease per RECIST 1.1
A fresh or recently acquired tumor tissue for the purpose of biomarker testing
World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Had prior cetuximab therapy (unless it was administered in curative locally advanced setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose)
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis
Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)

Intervenciones

drug

Monalizumab

Participants will receive IV infusion of monalizumab as stated in arm description.

drug

Cetuximab

Participants will receive IV infusion of cetuximab as stated in arm description.

other

Placebo

Participants will receive IV infusion of placebo as stated in arm description.

Ubicaciones

Research Site

CABA, Argentina

Research Site

CABA, Argentina

Research Site

CABA, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorInnate Pharma

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