WO46300: INAVOLISIB WITH BEVACIZUMAB PLUS FOLFOX IN PATIENTS WITH COLORECTAL CANCER
Research type
Research Study
Full title
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB WITH BEVACIZUMAB PLUS FOLFOX OR FOLFIRI AS FIRST LINE THERAPY IN PATIENTS WITH PIK3CA-MUTATED METASTATIC COLORECTAL CANCER
IRAS ID
1013188
Contact name
N/A N/A
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Eudract number
2025-523014-84
Research summary
Metastatic colorectal cancer (mCRC) is a cancer that starts in the lower part of the intestine, called the colon or rectum (colorectal) and has spread to other parts of the body. In some people, the cancer cells have a change (mutation) in a gene called PIK3CA. The usual treatment for mCRC, whether or not there is a change in the PIK3CA gene, includes a medicine called bevacizumab along with chemotherapy (a medicine that kills cancer cells). The chemotherapy treatment usually includes a combination of medicines, either 5-fluorouracil with oxaliplatin (called FOLFOX) or 5-fluorouracil with irinotecan (called FOLFIRI). Researchers are looking for new treatments for PIK3CA-mutated mCRC, as there is a strong need for better options. This study is testing a medicine called inavolisib, when given with the standard treatment (bevacizumab and either FOLFOX or FOLFIRI). It is being developed to treat PIK3CA-mutated mCRC. Inavolisib is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved inavolisib (when given with bevacizumab plus FOLFOX or FOLFIRI) for the treatment of PIK3CA-mutated mCRC. This study aims to compare how safe inavolisib is and how well it works versus a non-active medicine (placebo). People (males / females) of 18 years and older with mCRC can take part in the study if their cancer has a change (mutation) in a gene called PIK3CA and provided other study criteria are met (see below). People may not be able to take part in this study if they have received study treatment for cancer more than 4 weeks before starting this study, or if they have certain medical conditions such as diabetes or inflammatory bowel disease. They may also not be able to join if they have trouble swallowing pills. Women who are pregnant, trying to get pregnant, or currently breastfeeding cannot take part in the study. Other study criteria also apply.
REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0834
Date of REC Opinion
5 Jan 2026
REC opinion
Further Information Favourable Opinion