Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed recurrent and/or metastatic HNSCC that has been previously treated with systemic therapy in the recurrent and/or metastatic setting
Documented positive or negative human papillomavirus (HPV) status as determined locally by p16 immunohistochemistry (IHC; preferred), in situ hybridization, and/or by polymerase chain reaction-based assay
Eligible participants must not be suitable for treatment with surgery and/or radiation
Confirmation of biomarker eligibility: Valid results from either central testing of blood or local testing of blood or tumour tissue documenting PIK3CA-mutated tumour status
Consent to provide fresh (preferred) or archival tumour tissue specimen
Negative hepatitis B surface antigen (HBsAg) and total hepatitis B core antibody (HBcAb) test or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA at screening
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
Measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of \>=12 weeks
You may not be if
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 pathway
Appropriate for treatment with surgery and/or radiation at the time of entry into the study, as per national or local treatment guidelines
Type II diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type I diabetes
Malabsorption syndrome or other condition that would interfere with enteral absorption
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 criteria
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures twice per week or more frequently
Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
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 treatment or within 5 months after the final dose of study treatment
Uncontrolled tumor-related pain
Any concurrent ocular or intraocular condition excluding cataracts (e.g., 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 condition
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 eye
Requirement for daily supplemental oxygen
Symptomatic active lung disease, including pneumonitis
History of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis)
Known Human Immunodeficiency Virus (HIV) infection
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 complications
Chemotherapy, radiotherapy, or any other anti-cancer therapy within 2 weeks before enrolment
Investigational drug(s) within 4 weeks before enrolment
Unresolved toxicity from prior therapy, except for hot flashes, alopecia, and Grade \<=2 peripheral neuropathy
History of other malignancy within 5 years prior to screening, with specified exceptions
History of or active clinically significant cardiovascular dysfunction
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)
Chronic corticosteroid therapy of \>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
Allergy or hypersensitivity to components of the inavolisib, atezolizumab, or pembrolizumab formulation
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 treatment
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 treatment
Minor surgical procedures \<7 days prior to the first dose of study treatment
Prior serious immune-mediated toxicities resulting from treatment with any checkpoint inhibitor including, but not limited to, atezolizumab, pembrolizumab, or nivolumab
Treatment with any checkpoint inhibitor within 5 half-lives of Day 1 of Cycle 1
Uncontrolled or symptomatic hypercalcemia
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 exceptions
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 permitted
Active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteraemia, or severe pneumonia
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 study
Prior allogeneic stem cell or solid organ transplantation
Current treatment with anti-viral therapy for HBV
Treatment with systemic immunostimulatory agents within 4 weeks or five drug-elimination half-lives of the drug (whichever is longer)
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 exceptions
Poor peripheral venous access that would preclude repeated IV infusions
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
