Study on Bintrafusp Alfa with Chemoradiation for Patients with Esophageal Squamous Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called esophageal squamous cell carcinoma, which affects the esophagus, the tube that carries food from the mouth to the stomach. The study is testing a treatment called Bintrafusp alfa, also known by its code name MSB0011359C (M7824). This treatment is a special type of protein designed to block certain pathways in cancer cells, specifically the PD-L1 and TGF-β pathways, which may help in stopping the cancer from growing. The treatment is given as an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to see if combining Bintrafusp alfa with standard cancer treatments like chemotherapy and radiation is feasible for patients with this type of cancer. Chemotherapy involves using drugs like carboplatin and paclitaxel to kill cancer cells, while radiation uses high-energy rays to target and destroy cancer cells. The study will observe how well patients can complete the treatment plan, which includes at least two out of three planned cycles of Bintrafusp alfa.

Participants in the study will receive the treatment over a period of time and will be monitored for any side effects or changes in their condition. The study will also look at various outcomes, such as the safety of the treatment, how well the cancer responds, and the overall quality of life for the patients. This includes looking at symptoms like difficulty swallowing, which is common in esophageal cancer. The study aims to gather information that could help improve treatment options for people with this type of cancer in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of esophageal squamous cell carcinoma and ensuring adequate blood, kidney, and liver function.

Imaging tests such as endoscopic ultrasound, PET scan, and CT scan are performed to assess the tumor’s characteristics and determine if it is surgically irresectable.

2 treatment initiation

The treatment begins with the administration of bintrafusp alfa, a medication given through an intravenous (IV) infusion. This is a concentrate prepared for infusion.

The treatment plan includes three cycles of bintrafusp alfa, with the primary goal being the completion of at least two cycles.

3 chemoradiation therapy

Alongside bintrafusp alfa, chemoradiation therapy is administered. This involves the use of chemotherapy drugs, carboplatin and paclitaxel, combined with radiation therapy.

The chemoradiation aims to target the cancer cells in the esophagus and is delivered according to a schedule determined by the healthcare team.

4 monitoring and follow-up

Throughout the treatment, regular monitoring is conducted to assess the patient’s response and manage any side effects. This includes blood tests and imaging studies.

The study evaluates the safety and effectiveness of the treatment, focusing on the completion rate of chemotherapy and radiation, as well as the patient’s overall health and quality of life.

5 completion and evaluation

Upon completion of the treatment cycles, a final evaluation is performed to determine the treatment’s success and any progression of the disease.

The study also collects data on the patient’s survival, quality of life, and any potential biomarkers that may help in understanding the treatment’s impact.

Who Can Join the Study?

Must have a confirmed diagnosis of squamous cell carcinoma of the esophagus or the area where the esophagus meets the stomach. This means the type of cancer has been identified through a tissue sample.
Must have normal blood, kidney, and liver functions. This means your body is working well enough to handle the treatment.
If the tumor cannot be reached with a special tube called an endoscope for a detailed examination, you can still participate if you meet all other requirements.
Must provide written consent to participate, meaning you agree to join the study after understanding what it involves.
Must be able to visit the treatment center for management and follow-up appointments.
The cancer must be surgically irresectable, meaning it cannot be removed by surgery, as determined by specific scans. However, if the cancer has spread only to a specific area called the supraclavicular region, you can still participate. If you refuse surgery or cannot have surgery due to other health issues, you are also eligible.
If the cancer has come back in the same area after surgery or a specific type of treatment called endoscopic resection, but has not spread to other parts of the body, you can participate.
If the cancer has come back in the same area after a combination of treatments and surgery, but has not spread to other parts of the body, and if it is safe to give full radiation treatment, you can participate.
If the tumor extends below the area where the esophagus meets the stomach, most of the tumor must still be in the esophagus or the junction area.
Must be 18 years of age or older.
Must have an ECOG performance status of 0-2, which is a scale that measures how well you can perform daily activities. A score of 0-2 means you are fully active or can do most activities with some limitations.

Who Cannot Join the Study?

Patients who have a different type of cancer than esophageal squamous cell carcinoma cannot participate. This is a specific type of cancer that affects the cells lining the esophagus.
Patients who are not able to complete the treatment plan, which includes a combination of medications and radiation, are excluded. The treatment involves bintrafusp alfa, a medication used in the study, along with chemoradiation (a mix of chemotherapy and radiation therapy).
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not included in this study.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Deventer Ziekenhuis	Deventer	The Netherlands
Medisch Centrum Leeuwarden B.V.	Leeuwarden	The Netherlands
Gelre Hospitals	Zutphen	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Elisabeth-Tweesteden Ziekenhuis	Tilburg	The Netherlands
Dr. Bernard Verbeeten Instituut Stichting	Tilburg	The Netherlands
Audzgcxnx Usv	Amsterdam	The Netherlands
Rivdkdbwqbfctfmhlu Azrnua	Arnhem	The Netherlands
Rzddfpwdfhpdftsgty Icyfwlmhc Fwhgjiyym	Leeuwarden	The Netherlands
Rgbmwljeo Zqfrvihrkl Stsfzodnn	Arnhem	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	30.12.2020

Trial locations

Investigated drugs:

Bintrafusp Alfa

Bintrafusp alfa is a medication being studied for its potential to inhibit TGF-β and PDL-1, which are proteins that can help cancer cells evade the immune system. In this trial, it is being tested for its effectiveness in treating esophageal squamous cell carcinoma when used in combination with other treatments.

Carboplatin is a chemotherapy drug used to treat various types of cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, carboplatin is used as part of a chemoradiation therapy to treat esophageal squamous cell carcinoma.

Paclitaxel is another chemotherapy medication that helps stop the growth of cancer cells by interfering with their ability to divide. It is used in combination with other treatments in this trial to enhance the effectiveness of the therapy for esophageal squamous cell carcinoma.

Radiation therapy is a treatment that uses high-energy rays to kill cancer cells or stop them from growing. In this trial, radiation therapy is combined with chemotherapy and bintrafusp alfa to treat esophageal squamous cell carcinoma, aiming to improve the overall treatment outcome.

Esophageal squamous cell carcinoma – This is a type of cancer that forms in the flat cells lining the esophagus, which is the tube that carries food from the throat to the stomach. It typically begins in the upper and middle parts of the esophagus. As the disease progresses, it can cause difficulty swallowing, weight loss, and chest pain. The cancer may spread to nearby lymph nodes and other parts of the body. It is more common in individuals who smoke or consume alcohol excessively. Early stages might not show symptoms, making it challenging to detect without medical screening.

Trial ID:

2023-503312-32-00

Protocol code:

73750

NCT ID:

NCT04595149

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Bintrafusp Alfa with Chemoradiation for Patients with Esophageal Squamous Cell Carcinoma

What is this study about?

Who Can Join the Study?

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