A Phase I/Ib Study Evaluating Single-Agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers
Hoffmann-La Roche
Summary
The purpose of the study is to assess the safety and efficacy of inavolisib as a single-agent, in combination with atezolizumab, and in combination with pembrolizumab in participants with phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (PIK3CA)-mutated cancers, including previously treated head and neck squamous cell carcinoma (HNSCC).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 previously c…
Interventions
- DrugInavolisib
Participants will receive inavolisib, 9 milligram (mg), PO, QD on Days 1-21 of each 21-day cycle.
- DrugAtezolizumab
Participants will receive atezolizumab, 1200 mg, as IV infusion Q3W on Day 1 of each 21-day cycle.
- DrugPembrolizumab
Participants will receive pembrolizumab as an IV infusion Q3W on Day 1 of each 21-day cycle.
Locations (8)
- Moores Cancer Center at UC San Diego HealthLa Jolla, California
- California Cancer Associates for Research & Excellence, Inc.San Marcos, California
- Vanderbilt-Ingram Cancer CtrNashville, Tennessee
- BC Cancer Vancouver CentreVancouver, British Columbia
- Princess Margaret Cancer CenterToronto, Ontario
- Jewish General HospitalMontreal, Quebec