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
- Conditions
- ater-lines of Metastatic Colorectal CancerColorectal Cancer
- Registration Number
- NL-OMON53835
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
- 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
status
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary End Point:<br /><br>- Overall Survival (OS) in randomized participants with PD-L1 CPS (combined<br /><br>positive score;) >= 1<br /><br>- OS in all randomized participants</p><br>
- Secondary Outcome Measures
Name Time Method