Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies

Inclusion Criteria: * Able to understand and voluntarily sign the informed consent form, and able to comply with the study visit schedule and other protocol requirements. Written informed consent obtained prior to any screening procedures. * Age ≥ 18 years. * Dose escalation: * Any locally advanced or metastatic solid tumor malignancy with no curative treatment options available * Dose expansion: * HPV-associated locally advanced or metastatic platinum-resistant solid tumor malignancy. HPV positivity defined by positive p16 immunohistochemistry or in-situ hybridization assessment of archival tissue (primary or metastatic) in a CLIA-certified laboratory. Availability of pathology report from CLIA-certified lab demonstrating positive HPV status by p16 IHC or in situ hybridization qualifies for eligibility determination. Analysis of fresh tumor tissue is permitted in cases where archival tissue is not available. * Platinum resistance defined as prior progression (radiographic or clinical) either during or within 6 months following completion of platinum-based chemotherapy. * Platinum-based therapy as most recent systemic therapy prior to enrollment allowed but not required * Patients may have received any number of lines of prior systemic therapy for locally advanced/metastatic disease. * Eastern Cooperative Oncology Group performance status ≤ 1 * Patient has adequate bone marrow and organ function as defined by the following laboratory values: * Absolute neutrophil count (ANC)…