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Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL (NCT03026140)

Bristol-Myers Squibb
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 + COX2-inhibitors. This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be approximately 6 weeks.
  • Drug: Nivolumab
    Nivolumab 3mg/kg (day 1 and day 15), administered neoadjuvant before surgery
    • nivolumab (opdivo)
  • Drug: Ipilimumab
    Ipilimumab 1 mg/kg (day 1) ,administered neoadjuvant before surgery
    • Ipilimumab (Yervoy)
  • Drug: 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)
    • Celebrex
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
In this single-center, open-label, exploratory study, the investigators will enroll 60 patients within two years, including 30 patients with MSS tumors and 30 patients with MSI tumors. Patients with MSS tumors will be randomized to either group 1 or 2. Patients with MSI tumors will all be allocated to group 1.

Patients in group 1 will be treated with a single dose of ipilimumab 1mg/kg on day 1 and two cycles of nivolumab 3mg/kg on day 1 and 15, respectively.

Patients in group 2 will be treated with a single dose of ipilimumab 1mg/kg on day 1, two cycles of nivolumab 3mg/kg one day 1 and 15 and celecoxib daily until the day before surgery.

1 locations

Netherlands (1)
  • Antoni van Leeuwenhoek
    recruiting
    Amsterdam, Netherlands, 1066CX
Status:
recruiting
Type:
Interventional
Phase:
Start:
31 December, 2016
Updated:
22 January, 2017
Participants:
60
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