CO43909 - Inavolisib in PIK3 Mutated Head And Neck Cancers
Research type
Research Study
Full title
A PHASE I/Ib STUDY EVALUATING SINGLE-AGENT INAVOLISIB AND INAVOLISIB PLUS ATEZOLIZUMAB IN PIK3CA-MUTATED CANCERS
IRAS ID
1006126
Contact name
Rachel Tedds
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-006618-36
Research summary
The purpose of this study is to evaluate the effects of two drugs (inavolisib and atezolizumab) in patients with PIK3CA-mutated, recurrent and/or metastatic head and neck cancer. There are two treatment groups; Group A will receive inavolisib alone, Group B will receive inavolisib and atezolizumab. Each participant will be assigned to a treatment arm in the order in which he or she is enrolled.
PIK3CA is a gene that controls a message telling cells to grow and multiply. This message is often involved in cancer when cells lose the ability to turn it off. This messaging system is called the PI3K cancer pathway.
Inavolisib is designed to block the PI3K cancer pathway described above. Previous clinical study results support giving inavolisib to people whose cancer carries mutations in the PIK3CA gene. Inavolisib is an experimental drug, which means health authorities have not approved inavolisib for the treatment of cancer.
Atezolizumab is a protein that helps the immune system recognize and fight cancer cells by blocking a message (called PD-L1) that cancer cells use to evade the immune system. By blocking the PD-L1 pathway, atezolizumab may help the immune system stop or reverse the growth of tumours. Atezolizumab is approved by health authorities for several cancers, but not for recurrent and/or metastatic head and neck cancer.
Approximately 40 participants (6 from UK) are expected to be enrolled at up to 15 sites in 5 countries.The study consists of an optional pre-screening period, screening period of up to
28 days, study treatment period of 21-day cycles, and a post-treatment follow-up period.Participants will continue to take treatment on a regular basis unless their cancer worsens, they develop intolerable side effects or decide to withdraw from the study. Total time in the study will depend on how the participant responds to treatment. This could range from one day to more than 24 months.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0065
Date of REC Opinion
18 Sep 2023
REC opinion
Further Information Favourable Opinion