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Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer
Sponsor: The Netherlands Cancer Institute
Summary
In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs of distant metastases will be treated with short-term immunotherapy + novel IO combinations (i.e. anti-IL 8, COX2-inhibitors, anti-LAG3). This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be in between approximately 6 and 12 weeks.
Official title: Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
353
Start Date
2017-03-29
Completion Date
2032-03-01
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
Nivolumab 3mg/kg (day 1 and day 15), administered neoadjuvant before surgery
Ipilimumab
Ipilimumab 1 mg/kg (day 1) ,administered neoadjuvant before surgery
Celecoxib 200mg
celecoxib will be administered starting day 1 until 1 day before surgery daily (if patient is randomized to group 2 (only applicable for patients with a MSS tumor)
BMS-986253
BMS-986253 2400mg IV will be administered on day 1 and 15 (only applicable for patients with MSS tumors)
BMS-986016
Relatlimab will be administered IV, in cohort 5 240mg on day 1 and day 15, in cohort 6 480mg on day 1 and day 29, in cohort 7 160mg on day 1, day 29 and day 57
Locations (6)
Marieke van de Belt
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Spaarne Ziekenhuis
Haarlem, Netherlands
Tergooi
Hilversum, Netherlands
Haga ziekenhuis
The Hague, Netherlands