Immunotherapy in Patients With Early dMMR Rectal Cancer

Launched by ODENSE UNIVERSITY HOSPITAL · Feb 7, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of immunotherapy for patients with early-stage rectal cancer that has a specific genetic feature called dMMR. Traditionally, patients with this type of cancer undergo surgery, often combined with chemotherapy or radiation. However, recent findings suggest that immunotherapy could be a promising alternative. In a previous study, all patients treated with immunotherapy showed a complete response after six months, meaning their cancer was no longer detectable. The researchers believe that this approach may allow some patients to avoid surgery altogether, while still being closely monitored for any changes.

To be eligible for this trial, participants must be at least 18 years old, have non-metastatic rectal cancer (which means it hasn't spread), and have the dMMR genetic marker. They should not have received previous treatments for their cancer. If enrolled, participants will receive one or two cycles of immunotherapy and will be monitored regularly for their response. This trial aims to find a safer and more effective treatment option that could reduce the side effects and costs associated with traditional therapies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
• • 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.
• • 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).