Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer

• Status: Not yet recruiting
• Trial end date: 2027-10-31

Summary

This phase II trial compares atezolizumab in combination with chemotherapy (docetaxel, oxaliplatin, leucovorin calcium, fluorouracil, capecitabine) to atezolizumab alone for controlling the growth or spread of disease in patients with gastric and gastroesophageal junction cancers that have not spread from where they first started or have spread to nearby lymph nodes (locoregional) and have high microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR). The mismatch repair (MMR) system in the body corrects errors made during the copying of DNA and serves as a proofreading function. If corrections are not made, as occurs with dMMR, then MSI develops (which is when repeats in nucleotides [the subunits of DNA] within the DNA sequence occurs and changes the length of the DNA strand, resulting in errors when it's copied). This process results in multiple mutations in these cancers. It is known that tumors with MSI or dMMR respond very well to immunotherapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Chemotherapy drugs such as leucovorin calcium and fluorouracil work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Using atezolizumab in combination with chemotherapy may shrink or stabilize tumors in patients with localized gastric or gastroesophageal junction cancers.

• Phase: Phase 2

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Atezolizumab; Calcium; Calcium, Dietary; Capecitabine; Docetaxel; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin