Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

Signed written informed consent

Patients at least 18 years of age

Non-metastatic adenocarcinoma of the colon (and rectosigmoid considered as nonrectal and not undergoing neoadjuvant treatment)

No signs of distant metastases on CT-scan and physical examination;

Disqualifiers

No signs of distant metastases

No signs of obstruction or macroscopic bleeding or suspicion of perforation

Colonoscopy must be performed after registration to obtain study-specific biopsies. If biopsies are not possible, patients cannot be included in the study

WHO performance status of 0 or 1

Trial design

Treatments tested in this trial

  • Nivolumab
  • Ipilimumab
  • Celecoxib 200mg
  • BMS-986253
  • BMS-986016

Treatment groups

353 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

The Netherlands Cancer Institute

Lead sponsor

Bristol-Myers Squibb

Collaborator