About 10 to 15% of colon cancers that have not spread have a feature called dMMR, and chemotherapy works less well in them. In this study, patients received only about one month of immunotherapy before surgery (one dose of ipilimumab and two doses of nivolumab) and then had their operation. In 98% of patients the tumour shrank substantially, and in about two thirds no living cancer cells were left at the time of surgery. Almost all patients had surgery on time and severe side effects were rare. In the 3-year report (ESMO congress 2024), no patient's cancer had come back. This treatment does not yet have official approval for this use.
Locally advanced non-metastatic dMMR colon cancer; investigational
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Ipilimumab | 1 mg/kg | IV | Day 1 |
| Nivolumab | 3 mg/kg | IV | Days 1 and 15 |
As in the trial registration on ClinicalTrials.gov.
On the page “Immunotherapy and organ preservation in dMMR tumours” · Regimens from the key studies
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Ipilimumab 1 mg/kg IV on day 1 (one dose), with nivolumab 3 mg/kg IV on days 1 and 15 (two doses), before surgery; then standard colon surgery.
Source of the regimen details: ClinicalTrials.gov NCT03026140 (group 1: ipilimumab 1 mg/kg on day 1 and nivolumab 3 mg/kg on days 1 and 15, IV)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with untreated, locally advanced, non-metastatic mismatch repair-deficient (dMMR) colon cancer.
Two primary endpoints: safety, defined as timely surgery (delay of no more than 2 weeks in planned surgery due to treatment toxicity), and 3-year disease-free survival.
Secondary endpoints: pathological response and results of genomic analyses.
Grade 3 or 4 immune-related adverse events occurred in 5 patients (4%) and no patient discontinued treatment because of adverse events.
NICHE-2 showed that a short course of preoperative immunotherapy in locally advanced dMMR colon cancer is safe and produces a very high pathological response. In the report presented at ESMO 2024 (LBA24), with a median follow-up of 36.5 months after surgery, 3-year disease-free survival was 100% with no recurrences. However, this use of nivolumab and ipilimumab (neoadjuvant in colon cancer) is not approved by the FDA or EMA and its evidence comes from a single-arm study; randomised trials are ongoing.
The study was single-arm with no comparator group. About 95% of patients had a major pathological response, and without a control group the exact contribution of immunotherapy to survival cannot be compared with standard treatment. All patients underwent surgery after immunotherapy and the study did not assess non-operative management. The 3-year survival data have been published as a congress abstract.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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