Immunotherapy for early rectal cancer
Immunotherapy in Patients With Early dMMR Rectal Cancer
This study is testing if a new immunotherapy treatment can help adults with early-stage rectal cancer do better than the usual radiation or chemotherapy before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | nivolumab, ipilimumab, chemotherapy, immunotherapy |
| Locations | 5 sites (Aalborg and 4 other locations) |
| Trial ID | NCT05732389 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically verified non-metastatic rectal cancer at stages 1-3 and dMMR or MSI status.
Not a fit: Patients with metastatic rectal cancer or those who have previously undergone chemotherapy, radiotherapy, or immunotherapy for colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with early rectal cancer, potentially improving outcomes and quality of life.
How similar studies have performed: Other studies have shown promising results with immunotherapy in various cancer types, suggesting potential success for this novel approach in rectal cancer.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Aalborg and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.