Estudio de fase III, aleatorizado, doble ciego, controlad... | EligiMed

Estudio de fase III, aleatorizado, doble ciego, controlado con placebo de atezolizumab con o sin tiragolumab (anticuerpo anti-TIGIT) en pacientes con carcinoma de células escamosas de esófago irresecable cuya enfermedad no ha progresado tras quimiorradioterapia concurrente definitiva

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04543617Tipo: INTERVENTIONALInicio: 28 de sept de 2020Fin estimado: 31 de mar de 2027

Resumen

El objetivo de este estudio es evaluar la eficacia y la seguridad de tiragolumab más atezolizumab en comparación con placebo en participantes con carcinoma de células escamosas de esófago irresecable (o en aquellos que no pueden o no desean someterse a cirugía) y cuya enfermedad no ha progresado tras la quimiorradioterapia concurrente definitiva (dCRT). Los participantes serán aleatorizados en una proporción 1:1:1 para recibir tiragolumab más atezolizumab (Brazo A), placebo coincidente de tiragolumab más atezolizumab (Brazo B) o doble placebo (Brazo C).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study
dCRT treatment according to regional oncology guidelines for esophageal cancer
Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
Adequate hematologic and end-organ function prior to randomization
Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.

Criterios de exclusión

Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
Prior allogeneic stem cell or solid organ transplantation
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.

Intervenciones

drug

Tiragolumab

Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

drug

Atezolizumab

Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

drug

Tiragolumab Matching Placebo

Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

drug

Atezolizumab Matching Placebo

Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Ubicaciones

Instituto de Investigaciones Metabolicas (Idim)

Buenos Aires, Argentina

Fundacion Favaloro

Buenos Aires, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.