Actively Recruiting
Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer
Led by The Netherlands Cancer Institute · Updated on 2026-03-05
353
Participants Needed
6
Research Sites
778 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- At least 18 years of age
- Non-metastatic adenocarcinoma of the colon (rectosigmoid considered nonrectal and not receiving neoadjuvant treatment)
- No signs of distant metastases on CT scan and physical examination
- For dMMR cohorts 3 and 6: tumor stage greater than cT3 and/or lymph node positive (N+)
You will not qualify if you...
- Signs of obstruction, macroscopic bleeding, or suspicion of perforation
- Colonoscopy not performed after registration or inability to obtain study-specific biopsies
- WHO performance status greater than 1
- Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1
- For MSS tumor patients: current use of NSAIDs or COX2-inhibitors at registration
- Active peptic ulcer, gastrointestinal bleeding, unstable ischemic heart disease, peripheral arterial disease, or cerebrovascular disease
- Prior or planned radiotherapy before or after surgery
- History of allergy or severe hypersensitivity to study drug components, monoclonal antibodies, NSAIDs, or COX2-inhibitors
- Intercurrent illnesses including infections or unstable angina
- Positive test for hepatitis B surface antigen or hepatitis C RNA indicating infection
- Autoimmune disease
- Conditions requiring systemic corticosteroids (10 mg prednisone daily or more) or other immunosuppressive medications within 14 days before study drug
- Receipt of live vaccines within 4 weeks before inclusion
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Marieke van de Belt
Amsterdam, Netherlands, 1066CX
Actively Recruiting
2
OLVG
Amsterdam, Netherlands
Actively Recruiting
3
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
4
Spaarne Ziekenhuis
Haarlem, Netherlands
Actively Recruiting
5
Tergooi
Hilversum, Netherlands
Not Yet Recruiting
6
Haga ziekenhuis
The Hague, Netherlands
Not Yet Recruiting
Research Team
M
Marieke van de Belt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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