Estudio de fase 3, aleatorizado y abierto de relatlimab-nivolumab en combinación de dosis fija versus regorafenib o trifluridina + tipiracil (TAS-102) en participantes con cáncer colorrectal metastásico en líneas tardías de tratamiento

TerminadoFase 3ClinicalTrials.gov

ID: NCT05328908Tipo: INTERVENTIONALInicio: 28 de abr de 2022Fin estimado: 14 de jul de 2025

Resumen

El propósito de este estudio es evaluar relatlimab en combinación con nivolumab, administrado como combinación de dosis fija (nivolumab-relatlimab FDC, también denominado BMS-986213), para el tratamiento de participantes con cáncer colorrectal metastásico (CCRm) que no presenta alta inestabilidad de microsatélites (MSI-H)/deficiencia en la reparación de errores de emparejamiento (dMMR), que hayan fracasado al menos 1 pero no más de 4 líneas previas de tratamiento para enfermedad metastásica.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry.
Participants must have:.
i) progressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;.
ii) been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures.
Must have sufficient tumor tissue \& evaluable PD-L1 expression to meet the study requirements.
Must have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately.

Criterios de exclusión

Prior treatment with either an immunotherapy or with regorafenib or with TAS-102.
Untreated central nervous system (CNS) metastases, participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
History of refractory hypertension not controlled with anti-hypertensive therapy, myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary syndrome within 6 months prior to dosing, Class II congestive heart failure (as per the New York Heart Association Functional Classification), interstitial lung disease/pneumonitis or an active, known or suspected autoimmune disease.
Confirmed tumor microsatellite instable high/deficient mismatch repair (MSI-H/dMMR) status as per local standard testing; MSI/MMR test results from initial diagnosis are acceptable.

Intervenciones

drug

Nivolumab-relatlimab FDC

Specified dose on specified days

drug

Regorafenib

Specified dose on specified days

drug

TAS-102

Specified dose on specified days

Ubicaciones

Local Institution - 0022

Ciudad Autónoma Buenos Aires, Buenos Aires, Argentina

Local Institution - 0026

Ciudad Autónoma Buenos Aires, B, Argentina

Local Institution - 0024

Ciudad Autónoma Buenos Aires, Argentina

Local Institution - 0023

Río Grande, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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.

Estudio de fase 3, aleatorizado y abierto de relatlimab-n... | EligiMed