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
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

Contacts
Protocol Number
IRB:
PRO00110299

NCT:
NCT05328908
ClinicalTrials.gov
View on ClinicalTrials.gov