Clinical Trials for Rectal Neoplasm
There is currently 1 ongoing clinical trial for rectal neoplasm, testing the investigational drug dostarlimab in patients with untreated locally advanced disease. The trial is being conducted across multiple European countries including Spain, Germany, France, Netherlands, and Italy.
Clinical trial locations
- France
- Germany
- Italy
- Netherlands
- Spain
Study of Dostarlimab for Patients with Untreated Locally Advanced Rectal Cancer
This trial is focused on studying dostarlimab as a treatment for patients with locally advanced rectal cancer who have not yet received any treatment. The study specifically targets patients with a particular genetic subtype of cancer known as dMMR/MSI-H, which refers to certain characteristics of the cancer cells that affect how they behave and respond to treatment.
Inclusion criteria: To participate in this study, you must be at least 18 years old or the legal age of consent in your area. You need a confirmed diagnosis of Stage II to III locally advanced rectal adenocarcinoma, meaning the cancer is in the rectum and has grown into nearby tissues but has not spread to distant parts of the body. Your disease must be able to be evaluated using imaging tests and endoscopy. You must have a stored tissue sample from a previous biopsy or surgery available for testing. Your performance status must be ECOG 0 or 1, which means you are fully active or have some symptoms but can still do light work. You need to have adequate organ function, meaning your liver, kidneys, and other organs are working well enough to handle the treatment. Finally, your tumor must show either dMMR status or MSI-H phenotype, which are specific cancer cell characteristics.
Exclusion criteria: You cannot participate if you have already received any treatment for your rectal cancer. Patients with other types of cancer that are not specifically Stage II/III dMMR/MSI-H rectal cancer are excluded. If you are not within the specified age range for the study, you cannot join. Patients who cannot provide informed consent or understand the study requirements are also excluded. Additionally, patients who are part of a vulnerable population, which may include those with certain health conditions or social situations, are excluded to ensure their safety.
Study focus: The trial aims to evaluate how effective dostarlimab is in treating patients with this specific type of untreated rectal cancer. Participants will receive regular infusions of dostarlimab, administered directly into the bloodstream through a vein. After completing treatment, patients will undergo regular assessments to see if they maintain a complete response for 12 months, meaning the cancer does not show signs of returning or progressing. The study will continue monitoring participants for up to 3 years to evaluate long-term outcomes, including survival and freedom from disease progression or recurrence.
Investigational drug: Dostarlimab is an immune checkpoint inhibitor that works by blocking a protein called PD-1 on the surface of immune cells. This helps the body’s immune system recognize and attack cancer cells more effectively. In this trial, dostarlimab is administered as a 500 mg intravenous infusion under medical supervision. The medication is being studied for its ability to help shrink or control the cancer in patients with dMMR/MSI-H rectal cancer.
Summary
Currently, there is one clinical trial available for patients with rectal neoplasm, specifically targeting those with locally advanced disease who have not yet received treatment. This trial is focused on a particular genetic subtype of cancer known as dMMR/MSI-H and is testing the investigational drug dostarlimab, an immune checkpoint inhibitor.
The trial is being conducted across five European countries: Spain, Germany, France, Netherlands, and Italy, providing multiple locations for potentially eligible patients to access this research opportunity. The study involves long-term monitoring over a period of up to 3 years to assess both immediate and extended outcomes of the treatment.
Patients interested in participating should note that this trial is specifically for those who have not yet received any treatment for their rectal cancer and whose tumors show specific genetic characteristics that may make them more responsive to this type of immune-based therapy.