Actively Recruiting
Immunotherapy in Patients With Early dMMR Rectal Cancer
Led by Odense University Hospital · Updated on 2025-08-07
39
Participants Needed
5
Research Sites
1513 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this investigator-initiated, multicenter phase II trial is to evaluate the efficacy and tolerability of nivolumab and ipilimumab in patients with stage 1-3 MSI/dMMR rectal cancer. The primary objective is: Number of patients with complete clinical response after one or two cycles of immunotherapy. Patients will be treated with 1 or 2 cycles of combination immunotherapy: Cycle 1: Nivolumab 3 mg/kg days 1 and 15 \& ipilimumab 1 mg/kg day 1 Cycle 2: Nivolumab 3 mg/kg days 50 and 65 \& ipilimumab 1 mg/kg day 50
CONDITIONS
Official Title
Immunotherapy in Patients With Early dMMR Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically verified non-metastatic rectal cancer stage 1 to 3
- No indication for local therapy such as transanal endoscopic microsurgery (TEM)
- Histologically verified deficient mismatch repair (dMMR) or microsatellite instability (MSI)
- Performance status (WHO) of 0 or 1
- No previous chemotherapy, radiotherapy, or immunotherapy for colorectal cancer
- Adequate blood cell counts: neutrophils 2 1.5 x 10^9/L and platelets 2 100 x 10^9/L
- Adequate organ function: bilirubin 2 1.5 times upper normal limit and glomerular filtration rate (GFR) greater than 30 ml/min
- Women of childbearing potential must have a negative serum pregnancy test within five days before registration and agree to use highly effective birth control during the study and for six months after stopping study medication
- Provided written informed consent prior to any study procedures
- Written informed consent obtained according to local Ethics Committee requirements
You will not qualify if you...
- Any other condition or treatment that may pose a risk or interfere with study objectives as determined by the investigator
- Use of systemic glucocorticoids above the equivalent of 10 mg prednisolone per day; glucocorticoid treatment must end at least two weeks before inclusion
- Active, known, or suspected autoimmune disease, except for vitiligo, type I diabetes mellitus, residual hypothyroidism requiring only hormone replacement, psoriasis not requiring systemic treatment, or conditions unlikely to recur without external trigger
- Known allergy or intolerance to nivolumab or ipilimumab
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
3
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
5
Zealand University Hospital
Roskilde, Denmark, 4000
Actively Recruiting
Research Team
J
Julie Bach
CONTACT
C
Christian P Olsen, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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