Immunotherapy for early rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of immunotherapy, specifically Nivolumab and Ipilimumab, in patients with early-stage dMMR rectal cancer. The study aims to evaluate the effectiveness of these treatments as alternatives to traditional preoperative radiotherapy or chemoradiotherapy, which have not shown improvements in overall survival. Eligible participants include adults with non-metastatic rectal cancer who have not received prior chemotherapy, radiotherapy, or immunotherapy. The trial seeks to determine if immunotherapy can reduce locoregional recurrence while minimizing perioperative morbidity.

Why it matters

Who can join: the full rules

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).

Where it's running

• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of Oncology, Odense University Hospital
  Odense, Denmark Recruiting
• Zealand University Hospital
  Roskilde, Denmark Recruiting

Study contacts

• Principal investigator: Line S Tarpgaard, MD, Phd — Department of Oncology, Odense University Hospital, Denmark
• Study coordinator: Julie Bach
• Email: Julie.Kristina.Bach@rsyd.dk
• Phone: 30714320

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.