Immunotherapy Tested in Early Rectal Cancer With Mismatch Repair Deficiency
Tests nivolumab and ipilimumab in adults with early mismatch repair deficient rectal cancer.
Plain-language title generated from the registry record
Registry title: Immunotherapy in Patients With Early dMMR Rectal Cancer
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, Odense, and Roskilde, DenmarkSee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with early rectal cancer (stage 1-3) that has not spread and has a mismatch repair deficiency (dMMR) or MSI tumour change. It tests nivolumab and ipilimumab.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Rectal cancer that has not spread, stage 1-3, with no need for local treatment such as TEM. WHO performance status 0-1.
- Earlier treatment
- No earlier chemotherapy, radiotherapy or immunotherapy for colorectal cancer.
- Biomarker or test result
- Tumour shown under the microscope to be dMMR or MSI.
Main reasons for not taking part
- Taking steroid medicine above the equivalent of prednisolone 10 mg/day
- Active, known or suspected autoimmune disease (some mild forms are allowed)
- Known allergy or intolerance to nivolumab or ipilimumab
- Any other condition or treatment the investigator thinks is a risk to the patient
Read by machine on 9 November 2026.
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus University HospitalAarhus, DenmarkTaking people
- RigshospitaletCopenhagen, DenmarkTaking people
- Department of Oncology, Odense University HospitalOdense, DenmarkTaking people
- Zealand University HospitalRoskilde, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT05732389
- Record updated
- 7 August 2025
- Original description
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.Read full original descriptionShow less
Immunotherapy in Patients With Early dMMR Rectal Cancer
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
Inclusion: Age ≥ 18 years; Histologically verified non-metastatic rectal cancer stage 1-3; No indication for local therapy like TEM; Histologically verified dMMR or MSI; Performance status (WHO) of 0-1; No previous chemotherapy, radiotherapy or immunotherapy for colorectal cancer; Adequate haematological function defined as neutrophils ≥ 1.5 x 109/l and platelets ≥ 100 x 109/l; Adequate organ function (bilirubin ≤ 1.5 x UNL (upper normal limit), GFR (may be calculated) > 30 ml/min; Women of childbearing potential must have been tested negative in a serum pregnancy test within five days prior to registration. Fertile patients must agree to use a highly effective method of birth control. (i.e., pregnancy rate of less than 1 % per year) (Appendix 1) during the study and for six months after the discontinuation of study medication; Has provided written informed consent prior to performance of any study procedure; Written informed consent must be obtained according to the local Ethics Committee requirements.
Exclusion: Concomitant use of systemic glucocorticoids more than the equivalent dose to tablet prednisolone 10 mg/day. Treatment with systemic glucocorticoids must end no later than two weeks before inclusion; Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives; Subjects with active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol; Known allergy or intolerance to any of the drugs used (nivolumab and ipilimumab).