Study on the Effectiveness of Botensilimab and Balstilimab for Patients with Various dMMR and pMMR Tumors

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What is this study about?

This clinical trial is focused on studying various types of cancers, including but not limited to, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Endometrial Cancer, Breast Cancer, Prostate Cancer, and Sarcoma. The study aims to evaluate the effectiveness of a combination of two investigational drugs, Botensilimab and Balstilimab. Botensilimab, also known by its code name AGEN1181, is a type of protein called a monoclonal antibody that targets a specific protein on cancer cells. Balstilimab, or AGEN2034, is another monoclonal antibody that works by blocking a protein that helps cancer cells evade the immune system.

The purpose of this study is to determine how well these drugs work together in treating the cancers mentioned. Participants will receive these medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will observe the response of the tumors to this treatment, particularly looking for a significant reduction in the amount of cancerous tissue remaining after the treatment. This is known as a major pathologic response, where ideally less than 10% of the tumor remains after the treatment.

The study will also assess the safety and feasibility of using these drugs before surgery in patients with these cancers. Participants will be monitored for any side effects and the overall impact of the treatment on their health. The trial will help researchers understand if this combination of drugs can be a beneficial treatment option for patients with these types of cancers.

1 joining the study

Upon joining the study, the patient must provide a signed written informed consent.

Eligibility is confirmed based on specific criteria, including age, cancer type, and health status.

2 initial assessment

An initial assessment is conducted to evaluate the patient’s health and eligibility for the trial.

This includes laboratory tests and a review of medical history.

3 treatment administration

The patient receives two medications: botensilimab and balstilimab.

Both medications are administered as a solution for infusion through an intravenous route.

The frequency and duration of administration are determined by the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the patient’s response to the treatment.

This includes physical examinations, imaging studies, and laboratory tests.

5 surgical evaluation

After the treatment phase, a surgical evaluation is performed to assess the tumor response.

The primary goal is to determine the major pathologic response rate, which is defined as having 10% or less viable tumor remaining.

6 end of trial participation

The trial concludes with a final assessment of the patient’s health and treatment outcomes.

Long-term follow-up may be conducted to monitor for any recurrence or progression of the disease.

Who Can Join the Study?

  • You must sign a written informed consent form, which means you agree to participate in the study after understanding all the details.
  • If you have a type of cancer called pMMR tumors, you should not need a treatment called neoadjuvant therapy, unless another treatment option is considered standard care.
  • You must be at least 18 years old.
  • You should have a type of cancer that has not spread to other parts of the body, known as non-metastatic cancer. This includes specific types like sarcoma, cervical cancer, head and neck cancers, anal cancer, and esophageal cancer.
  • You must be eligible for a study biopsy, which is a procedure to take a small sample of tissue for testing.
  • You should have a WHO performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
  • Your blood tests must meet certain criteria, such as having enough white blood cells, platelets, and hemoglobin, and normal liver and kidney function. These tests should be done within 7 days before you start the study.
  • If you are a woman who can have children, you must use a reliable method of birth control during the study and for 20 weeks after the last dose of the study drug. You must also have a negative pregnancy test within 7 days before starting the study.
  • If you are a man who is sexually active with a woman who can have children, you must use a reliable method of birth control during the study and for 28 weeks after the last dose of the study drug. You should not donate sperm during this time.

Who Cannot Join the Study?

  • Patients with a history of severe allergic reactions to similar drugs.
  • Patients who are currently pregnant or breastfeeding.
  • Patients with active infections that require treatment.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have received another investigational drug within a certain time frame before the study.
  • Patients with a history of certain types of cancer that are not part of the study.
  • Patients who have had a major surgery recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
  • Patients with a known history of certain immune system disorders.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
15.09.2023

Trial locations

Investigated drugs:

Botensilimab is an investigational medication used in this clinical trial. It is being studied for its potential to help the body’s immune system recognize and attack cancer cells. In this trial, it is combined with another medication to see if it can improve the treatment outcomes for patients with certain types of tumors.

Balstilimab is another investigational medication used in the trial. Like botensilimab, it is designed to enhance the immune system’s ability to fight cancer. The trial is exploring how well balstilimab works when used together with botensilimab in treating tumors.

Colorectal Cancer – This is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, it can invade deeper layers of the colon or rectum and spread to nearby lymph nodes or other organs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression can vary, with some cases remaining localized while others spread more aggressively.

Esophageal Cancer – This cancer occurs in the esophagus, the long tube that carries food from the throat to the stomach. It typically begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby tissues. As it progresses, it may cause difficulty swallowing, weight loss, and chest pain. The disease can spread to lymph nodes and other organs, complicating its course. The progression rate can differ based on the cancer type and location within the esophagus.

Gastric Cancer – Also known as stomach cancer, this disease starts in the stomach lining and can grow to affect deeper layers and nearby organs. It often begins with subtle symptoms like indigestion and progresses to more severe signs such as weight loss and vomiting. As it advances, it can spread to lymph nodes and distant organs. The progression can be slow or rapid, depending on various factors, including the cancer’s type and location.

Duodenal and Small Bowel Cancer – This rare cancer affects the small intestine, particularly the duodenum, which is the first part of the small bowel. It can start in the lining and grow to invade deeper tissues and nearby structures. Symptoms may include abdominal pain, weight loss, and nausea. The disease can spread to lymph nodes and other organs, affecting its progression. The rate of progression can vary significantly among individuals.

Endometrial Cancer – This cancer begins in the lining of the uterus, known as the endometrium. It often presents with abnormal vaginal bleeding, especially after menopause, and can progress to invade the uterine wall and nearby tissues. As it advances, it may spread to lymph nodes and other parts of the body. The progression can be influenced by factors such as hormone levels and the cancer’s specific characteristics.

Breast Cancer – This is a common cancer that starts in the breast tissue, often in the ducts or lobules. It can grow to invade surrounding tissues and spread to lymph nodes and other organs. Symptoms may include a lump in the breast, changes in breast shape, and skin dimpling. The progression can vary widely, with some cancers growing slowly and others spreading rapidly.

Prostate Cancer – This cancer occurs in the prostate gland, which is part of the male reproductive system. It often grows slowly and may initially cause no symptoms, but as it progresses, it can lead to urinary difficulties and pelvic discomfort. The disease can spread to bones and other organs, affecting its progression. The rate of progression can differ based on the cancer’s type and stage.

Sarcoma – Sarcomas are a group of cancers that begin in the bones or soft tissues, such as muscles and fat. They can grow to invade nearby tissues and spread to other parts of the body. Symptoms depend on the tumor’s location and may include a noticeable lump or swelling. The progression can vary, with some sarcomas growing slowly and others spreading more aggressively.

Trial ID:
2023-505756-21-00
NCT ID:
NCT06279130
Trial Phase:
Therapeutic exploratory (Phase II)

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