Relatlimab-nivolumab versus regorafenib or trifluridine + tipiracil for colorectal cancer
What is the Purpose of this Study?
If you choose to join this study, you will:
- Be assigned to get either relatlimab-nivolumab or an existing therapy (regorafenib or trifluridine + tipiracil)
- Get IV infusions of relatlimab-nivolumab every 4 weeks (if assigned) OR take pills of your assigned standard-of-care therapy
- Give blood and urine samples
- Have regular CT or MRI scans
- Be assigned to get either relatlimab-nivolumab or an existing therapy (regorafenib or trifluridine + tipiracil)
- Get IV infusions of relatlimab-nivolumab every 4 weeks (if assigned) OR take pills of your assigned standard-of-care therapy
- Give blood and urine samples
- Have regular CT or MRI scans
What is the Condition Being Studied?
Colorectal Adenocarcinoma
Who Can Participate in this Study?
Adults who:
- Are diagnosed with with colorectal adenocarcinoma that is metastatic or unresectable (cannot be surgically removed)
- Have had their cancer worsen following prior lines of therapy
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to compare the combination study drug, relatlimab-nivolumab, to existing standard-of-care therapies.
Study Details
Full Title
[CA224123] 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
Principal Investigator
Protocol Number
IRB:
PRO00110299
NCT:
NCT05328908
ClinicalTrials.gov
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