Anal cancer metastatic Trials in Disease

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

This clinical trial is being conducted in Germany and focuses on testing a new treatment approach for patients with advanced or metastatic gastrointestinal cancers. The study combines two investigational drugs, pelareorep and atezolizumab, with standard chemotherapy treatments.

Main inclusion criteria:

• Patients must have advanced or metastatic gastrointestinal tumors that have spread to other parts of the body
• Age 18 years or older
• Good general health status (ECOG performance status of 0 or 1), meaning patients can carry out daily activities with minimal assistance
• Measurable cancer lesions that can be tracked during treatment
• Adequate blood counts, including sufficient white blood cells (at least 1500/mm³), platelets (at least 75,000/mm³), and hemoglobin (greater than 8 g/dL)
• Proper liver function with liver enzyme levels no more than 2.5 times the normal limit (or 5 times for patients with liver metastasis)
• Adequate kidney function with creatinine levels no more than 1.5 times the normal limit
• Recovery from previous treatment side effects
• Agreement to use effective contraception during the study and for 6 months after treatment for patients of childbearing potential

Main exclusion criteria:

• Patients without advanced or metastatic gastrointestinal tumors
• Inability to tolerate the combination of study drugs and standard chemotherapy
• Patients who are part of vulnerable populations that the study is not designed to include

Focus and goal of the trial:

The trial aims to evaluate the safety and effectiveness of combining pelareorep and atezolizumab with standard chemotherapy for treating advanced gastrointestinal cancers. The study will monitor how well patients respond to this combination therapy and how well they tolerate the treatment. Researchers will assess the overall response rate, which measures whether the cancer shrinks or disappears, and the disease control rate, which indicates how well the treatment prevents the cancer from growing or spreading.

The study follows a structured approach with regular assessments. At week 16, doctors will evaluate how the cancer is responding to treatment by measuring the size of cancer lesions. Throughout the trial, participants undergo regular check-ups and tests to monitor their health and any side effects. The study is expected to conclude by December 31, 2026.

Investigational drugs:

Pelareorep is an oncolytic virus therapy that uses a specially designed virus to target and kill cancer cells while leaving healthy cells unharmed. It works by infecting cancer cells and causing them to burst, which stimulates an immune response against the tumor. The medication is given as an infusion directly into the bloodstream through a vein.

Atezolizumab is an immune checkpoint inhibitor that helps the immune system fight cancer. It works by blocking a protein called PD-L1 that prevents the immune system from attacking cancer cells. By blocking this protein, atezolizumab allows the immune system to better recognize and destroy cancer cells. Like pelareorep, it is also administered through intravenous infusion.