Study of Dostarlimab for Patients with Untreated Locally Advanced Rectal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called locally advanced rectal cancer. Specifically, it involves patients with a subtype known as dMMR/MSI-H rectal cancer, which refers to certain genetic characteristics of the cancer cells. The treatment being tested in this study is a medication called Dostarlimab, which is given as an infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective Dostarlimab is in treating patients who have not received any prior treatment for their cancer. Participants in the study will receive this medication and will be monitored over time to see how their cancer responds. The study will track the progress of the disease and assess the overall health and well-being of the participants throughout the treatment period.

During the study, participants will receive regular infusions of Dostarlimab and will have follow-up visits to check on their health and the status of their cancer. The study aims to gather information over several years to understand the long-term effects and benefits of the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Dostarlimab with no treatment. The study is designed to provide valuable insights into the potential of Dostarlimab as a treatment option for this specific type of rectal cancer.

1 joining the study

Upon joining the study, the participant is required to provide a tissue sample for testing. This sample is used to confirm the presence of specific cancer characteristics.

The participant must have a performance status that indicates they are able to carry out daily activities without significant restriction.

2 treatment administration

The participant receives the medication dostarlimab, which is administered as a solution for infusion. This means the medication is given through a vein, a process known as intravenous use.

The dosage of the medication is 500 mg. The frequency and duration of administration are determined by the study protocol and the participant’s response to the treatment.

3 disease assessment

After the last dose of the study medication, the participant undergoes regular assessments to evaluate the response to the treatment.

The primary goal is to maintain a complete response for 12 months. This means the cancer does not show signs of returning or progressing during this period.

4 extended monitoring

If the participant maintains a complete response for 12 months, further assessments are conducted to monitor the response for 24 months and 36 months.

The study also evaluates the participant’s survival and freedom from disease progression or recurrence over a period of 3 years from the first dose of the medication.

Who Can Join the Study?

Must be at least 18 years old or the legal age of consent in your area.
Must have a confirmed diagnosis of Stage II to III locally advanced rectal adenocarcinoma. This means the cancer is in the rectum and has grown into nearby tissues but has not spread to distant parts of the body.
Must have a disease that can be evaluated using imaging tests and a procedure called an endoscopy, which involves looking inside the body with a camera.
Must have a stored tissue sample from a previous biopsy or surgery that can be sent for testing.
Must have an ECOG performance status of 0 or 1. This is a scale used to assess how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some symptoms but can still do light work.
Must have adequate organ function, meaning your organs like the liver and kidneys are working well enough to handle the treatment.
Must have a tumor that shows either dMMR status or MSI-H phenotype. These are specific characteristics of the cancer cells that can affect how the cancer behaves and responds to treatment.

Who Cannot Join the Study?

Patients who have already received treatment for their rectal cancer cannot participate. Rectal cancer is a type of cancer that affects the last part of the large intestine.
Patients with other types of cancer, not specifically Stage II/III dMMR/MSI-H rectal cancer, are excluded. Stage II/III refers to the extent or severity of the cancer, and dMMR/MSI-H are specific characteristics of the cancer cells.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to provide informed consent or understand the study requirements are excluded. Informed consent means agreeing to participate in the study after understanding all the details and risks involved.
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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Istituto Oncologico Veneto	Padua	Italy
Hopital Saint Antoine	Paris	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Rennes	Rennes	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hssmpycb Urlndepqhxnmu Migydtz Dj Vvrxubjcls	Santander	Spain
Uxbhdfxyoogtnaleaaflj Divsrzypxof Abg	Duesseldorf	Germany
Bgtjnkrf Ufdifmdosh Hzewimoa Cizydh	Besançon	France
Ksrfnnin dhi Uwvitlqithfs Mvqkaqkd Agz	Munich	Germany
Hdlgerqg Voje duslkjmf	Barcelona	Spain
Ipggbtcm Prezpbmedkosdee Cjvwjy Ciqzke	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	20.03.2023
Germany	Recruiting	20.03.2023
Italy	Not recruiting	20.03.2023
Spain	Not recruiting	20.03.2023
The Netherlands	Not recruiting	20.03.2023

Trial locations

Investigated drugs:

Dostarlimab

Dostarlimab is a medication being studied for its effectiveness in treating certain types of rectal cancer. It is used in patients who have not received any prior treatment for their cancer. The goal of the study is to see how well dostarlimab works in shrinking or controlling the cancer.

Investigated diseases:

Rectal cancer

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It often starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2023-509583-22-00

Protocol code:

219369

NCT ID:

NCT05723562

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Dostarlimab for Patients with Untreated Locally Advanced Rectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?