Immunotherapy in patients with early dMMR rectal cancer. A Danish DCCG phase II trial

Phase 1

Recruiting

• Conditions: cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500646-14-00
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Age = 18 years., 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., 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) during the study and for six months after the discontinuation of study medication.

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified