Study on Pelareorep and Atezolizumab for Patients with Advanced or Metastatic Gastrointestinal Cancers

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What is this study about?

This clinical trial is focused on studying advanced or metastatic gastrointestinal cancers, which are cancers that affect the digestive system. The study is exploring the effects of two treatments: pelareorep and atezolizumab. Pelareorep is also known by other names such as Reovirus Type 3 Dearing, and atezolizumab is sometimes referred to by its code name, RO5541267. Both medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effectiveness of combining pelareorep and atezolizumab with standard chemotherapy treatments. Participants will receive these treatments and be monitored for their response to the therapy. The study will assess how well the combination of these drugs works in treating the cancer and how well patients tolerate the treatment. The study will also look at the overall response rate, which measures how the cancer responds to the treatment, and the disease control rate, which indicates how well the treatment keeps the cancer from growing or spreading.

Throughout the study, participants will undergo regular assessments to monitor their health and the effects of the treatment. These assessments will include checking for any side effects and measuring the size of the cancer to see how it responds to the treatment. The study aims to provide valuable information on the potential benefits of using pelareorep and atezolizumab together with standard chemotherapy for treating advanced gastrointestinal cancers.

1 joining the study

Upon joining the study, you will provide written informed consent. This means you agree to participate after understanding the details of the study.

You must be at least 18 years old and have a performance status that allows you to carry out daily activities with minimal assistance.

2 initial assessment

An initial assessment will be conducted to ensure you meet the study’s health criteria. This includes checking your blood counts, liver and kidney function, and other health parameters.

You will need to have measurable lesions, which are areas of cancer that can be measured to track changes during the study.

3 treatment administration

You will receive two medications: pelareorep and atezolizumab. Both are given as a solution for infusion, which means they are administered directly into your bloodstream through a vein.

The frequency and dosage of these medications will be determined by the study protocol and your specific health needs.

4 ongoing monitoring

Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to assess how your body is responding to the treatment.

You will be asked to report any side effects or changes in your health to the study team.

5 evaluation of response

At week 16, your response to the treatment will be evaluated. This involves measuring the size of your cancer lesions to see if they have changed.

The study aims to assess the overall response rate, which is the percentage of patients whose cancer shrinks or disappears after treatment.

6 completion of study

After completing the treatment phase, there will be a follow-up period to monitor your long-term health and any lasting effects of the treatment.

The study is expected to end by December 31, 2026, but your participation may conclude earlier depending on your health and the study’s progress.

Who Can Join the Study?

Patients must have advanced or metastatic gastrointestinal (GI) tumors.
Patients must provide written informed consent before participating in the study.
Patients must be at least 18 years old on the day they give consent.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
Patients must have measurable or evaluable lesions according to RECIST v1.1, which is a set of rules to measure how tumors respond to treatment.
Patients must have adequate organ function, which includes:
- Absolute neutrophil count of at least 1500/mm³. Neutrophils are a type of white blood cell important for fighting infections.
- Platelet count of at least 75,000/mm³ (or 100,000/mm³ for certain patients). Platelets help with blood clotting.
- Hemoglobin level greater than 8 g/dL (or 9 g/dL for certain patients). Hemoglobin is a protein in red blood cells that carries oxygen.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels no more than 2.5 times the upper limit of normal (or 5 times for patients with liver metastasis). These are liver enzymes.
- Total bilirubin level no more than 1.5 times the upper limit of normal. Bilirubin is a substance made during the normal breakdown of red blood cells.
- Creatinine level no more than 1.5 times the upper limit of normal (or 1.0 times for certain patients). Creatinine is a waste product from the normal breakdown of muscle tissue.
- For certain patients, albumin level of at least 3.0 g/dL. Albumin is a protein made by the liver.
- International normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) no more than 1.5 times the upper limit of normal, unless receiving treatment with blood thinners. These are tests that measure how well and how long it takes your blood to clot.
Patients must have recovered to a level of 1 or baseline for all side effects from previous treatments or surgeries.
Female patients who can become pregnant and male patients with partners who can become pregnant must agree to use highly effective contraception methods during the study and for 6 months after the last dose of the study drug.

Who Cannot Join the Study?

Patients who do not have advanced or metastatic gastrointestinal (GI) tumors. Metastatic means that the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to tolerate the combination of the study drugs and standard chemotherapy. Tolerate means being able to handle the side effects of the treatment.
Patients who are not able to respond to the treatment as required by the study.
Patients who are part of a vulnerable population that the study is not designed to include. Vulnerable population refers to groups of people who may be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Haematologie-Onkologie im Zentrum MVZ GmbH	Augsburg	Germany
St. Josef-Hospital	Bochum	Germany
Caritas Traegergesellschaft Saarbruecken mbH (CTS)	Saarbrücken	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Kelnexro dux Umyyuviqsmhv Myplyfuw Ajr	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	28.07.2021

Trial locations

Investigated drugs:

Pelareorep is a type of therapy that uses a virus to help fight cancer. This virus is specially designed to target and kill cancer cells while leaving normal cells unharmed. In this trial, pelareorep is being tested to see how well it works when combined with other treatments for advanced or metastatic gastrointestinal cancers.

Atezolizumab is a medication that helps the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. By blocking this protein, atezolizumab allows the immune system to better recognize and destroy cancer cells. In this trial, it is being used in combination with other treatments to see if it can improve outcomes for patients with advanced or metastatic gastrointestinal cancers.

Investigated diseases:

Gastrointestinal Tumors – Gastrointestinal tumors are abnormal growths that occur in the digestive tract, which includes the stomach, intestines, and other parts of the digestive system. These tumors can be benign or malignant, with malignant tumors being cancerous and capable of spreading to other parts of the body. The progression of gastrointestinal tumors varies depending on the type and location of the tumor. Malignant tumors may invade surrounding tissues and organs, leading to complications in the digestive process. As the disease progresses, symptoms such as abdominal pain, weight loss, and changes in bowel habits may become more pronounced. The growth and spread of these tumors can disrupt normal digestive functions and impact overall health.

Trial ID:

2024-515936-62-00

Protocol code:

REO 029

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Pelareorep and Atezolizumab for Patients with Advanced or Metastatic Gastrointestinal Cancers

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