A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines of Metastatic Colorectal Cancer - RELATIVITY-123

Bristol-Myers Squibb0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•- Histologically confirmed previously treated CRC with adenocarcinoma histology
•with metastatic or recurrent unresectable disease at study entry.
•- Participants must have:
•a)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), which must include a fluoropyrimidine, oxaliplatin,
•irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if
•approved in the respective country, or;
•b)been intolerant to prior systemic chemotherapy regimens if there is
•documented evidence of clinically significant intolerance despite adequate
•supportive measures.
•- Participants must have sufficient tumor tissue & evaluable PD-L1
•expression to meet the study requirements. Participants with indeterminate
•PD-L1 results will be stratified with those participants assessed to be PD-L1
•negative by CPS (see next slide for details).
•- KRAS mutation status must be documented based on available historical or
•local testing results as part of medical history prior to study enrollment.
•- Participants 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.

•- Prior treatment with either an immunotherapy (anti-LAG-3, anti-PD-1,
•anti-PD-L1, or anti-CTLA-4 antibody, or any other antibody or drug specifically
•targeting T-cell co-stimulation or checkpoint pathways) or with regorafenib or
•with TAS-102.
•- Untreated 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)
•- Participants with 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.
•- In the case of prior SARS-CoV-2 infection, acute symptoms must have
•completely resolved and based on investigator assessment in consultation with
•the clinical trial physician, there are no sequelae that would place the
•participant at a higher risk of receiving investigational treatment.
•- Participants with historically or locally confirmed tumor MSI-H/dMMR

发起方

Bristol-Myers Squibb