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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Clinical
Trials
+1 (0)888 662 6728
global-roche-genentech-trials@gene.com
More information about this study, what is involved and how to take part can be found on the study website.
PIK3CA-mutated solid cancers including previously treated recurrent or metastatic HNSCC
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Cancer is a disease in which abnormal cells divide without control and can invade nearby tissues. Cancers that are known collectively as head and neck cancers usually begin in the squamous cells (a flat cell that looks like a fish scale under a microscope) that form the moist, inner lining of the head and neck (for example, those inside the mouth, throat, and voice box). The risk factors for head and neck squamous cell carcinoma (HNSCC) include tobacco use, alcohol consumption, and infection with human papillomavirus (HPV). Studies of HNSCC tumours show that there is a frequent occurrence of a mutation in the PIK3CA gene. 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, the drug that is being studied, is designed to block the wrong messaging from the mutated PIK3CA gene and, therefore, block the PI3K cancer pathway described above. Inavolisib is an experimental drug, which means health authorities have not approved inavolisib for the treatment of cancer. In this study, inavolisib will be tested with or without a drug called atezolizumab. Atezolizumab has been approved by health authorities for several cancers, but not for recurrent and/or metastatic HNSCC (cancer that has come back and/or spread to other organs).
The main aims of this study are:
1. To evaluate the effects, good or bad, of inavolisib alone or inavolisib plus atezolizumab in participants with PIK3CA-mutated, recurrent and/or metastatic HNSCC cancer
2. To determine how safe and tolerable inavolisib is when given alone or in combination with atezolizumab in participants with PIK3CA-mutated, recurrent and/or metastatic HNSCC cancer
3. To assess the anti-tumour activity of inavolisib when given alone or in combination with atezolizumab in participants with PIK3CA-mutated, recurrent and/or metastatic HNSCC cancer
4. To determine how the body absorbs, distributes, and eliminates inavolisib when given alone or in combination with atezolizumab
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Prior treatment with any phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or any agent whose mechanism of action is to inhibit the PI3K/AKT/mTOR pathway2. Appropriate for treatment with surgery and/or radiation at the time of entry into the study, as per national or local treatment guidelines3. Type II diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type I diabetes4. Malabsorption syndrome or other condition that would interfere with enteral absorption5. Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible provided they meet specified criteria6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures twice per week or more frequently7. Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 18. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of the need for such a vaccine during study treatment9. Any concurrent ocular or intraocular condition (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition10. Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis, keratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye11. Requirement for daily supplemental oxygen12. Symptomatic active lung disease, including pneumonitis13. History of or active inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis)14. Known Human Immunodeficiency Virus (HIV) infection15. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic, or infectious disease) or any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that renders the participant at high risk from treatment complications16. Chemotherapy, radiotherapy, or any other anti-cancer therapy within 2 weeks before enrolment17. Investigational drug(s) within 4 weeks before enrolment18. Unresolved toxicity from prior therapy, except for hot flashes, alopecia, and Grade ≤ 2 peripheral neuropathy19. History of other malignancy within 5 years prior to screening, with specified exceptions20. History of or active clinically significant cardiovascular dysfunction21. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study)22. Chronic corticosteroid therapy of ≥10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease23. Allergy or hypersensitivity to components of the inavolisib formulation24. Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors within 1 week or five drug-elimination half-lives, whichever is longer, prior to initiation of study treatment25. Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1; or anticipation of the need for major surgery during study treatment26. Minor surgical procedures <7 days prior to the first dose of study treatment
Exclusion criteria specific to arms utilizing atezolizumab:27. Prior serious immune-mediated toxicities resulting from treatment with any checkpoint inhibitor including, but not limited to, atezolizumab, pembrolizumab, or nivolumab28. Treatment with any checkpoint inhibitor within 5 half-lives of Day 1 of Cycle 129. Uncontrolled or symptomatic hypercalcemia30. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with specified exceptions31. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan; a history of radiation pneumonitis in the radiation field (fibrosis) is permitted32. Active tuberculosis33. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteraemia, or severe pneumonia34. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment; participants receiving prophylactic antibiotics may be eligible for the study35. Prior allogeneic stem cell or solid organ transplantation36. Current treatment with anti-viral therapy for HBV37. Treatment with systemic immunostimulatory agents within 4 weeks or five drug-elimination half-lives of the drug (whichever is longer)38. Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of the need for systemic immunosuppressive medication during study treatment, with specified exceptions39. Poor peripheral venous access that would preclude repeated IV infusions40. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins41. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Clinical
Trials
+1 (0)888 662 6728
global-roche-genentech-trials@gene.com
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by F. Hoffmann-La Roche Ltd and funded by F. Hoffmann-La Roche.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
