INCA033890-303 - INCA33890 in Colorectal cancer
Research type
Research Study
Full title
A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First -Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
IRAS ID
1013455
Contact name
Florence Mottu
Sponsor organisation
Incyte Corporation
Eudract number
2025-523735-19
Clinicaltrials.gov Identifier
Research summary
The purpose of this double-blind, randomised, phase III study is to compare how safe and effective a Study Drug called INCA33890 is when added to standard of care treatment with bevacizumab and a chemotherapy combination called FOLFOX (oxaliplatin, fluorouracil, and leucovorin or levoleucovorin) to treat Colorectal Cancer (CRC). CRC is a disease where cells in the colon or rectum grow out of control, forming cancerous tumours.
Eligible participants will be randomly assigned to receive the Study Drug or Placebo in addition to FOLFOX plus Bevacizumab.
The assigned study treatment – whether the study drug or placebo is given as an injection directly into the vein (intravenous, or “IV”) every 2 weeks for up to 2 years.
Standard treatment (bevacizumab and FOLFOX) may continue beyond 2 years if the participant is benefitting.
• Bevacizumab will be given by IV every 2 weeks until the study doctor decides it should be stopped.
• Oxaliplatin will be given by IV every 2 weeks for up to 6 months.
• Leucovorin or levoleucovorin will be given by IV every 2 weeks until participants meet the discontinuation criteria or as long as they receive fluorouracil.
• Fluorouracil will be given by IV every 2 weeks until participants meet the discontinuation criteria. The first dose is given at the hospital over 5 minutes, then participants will go home with a small, portable pump that gives them the medicine over about 2 days.
There are 3 periods in this study: screening period, study treatment period, and follow-up period.
It is estimated the Study Treatment will continue for an average of 11-15 months, but this will vary between participants.
Participants will have a follow-up visit about 1 month after they have completed the treatment phase. After the follow-up visit, participants will be contacted by the study staff every 3 months to check their health.
About 700 participants will be recruited for this study in approximately 14 countries, including the United Kingdom.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0042
Date of REC Opinion
27 Mar 2026
REC opinion
Further Information Favourable Opinion