My Pathway: An Open Label Phase IIA Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, and Vismodegib in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents

This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.

Inclusion Criteria:
• Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating anaplastic lymphoma kinase (ALK) gene rearrangements, ALK mutations, ALK copy number gain or (for melanoma only) increased ALK expression or presence of ALK-alternative transcription initiation transcript (ALKATI) a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrolment)
• Molecular testing results from CLIA-certified laboratories (using tissue) demonstrating programmed death-ligand 1 (PD-L1) copy number gain/amplification, deficiency in mismatch repair enzymes (dMMR), high levels of microsatellite instability (MSI-H) or elevated tumor mutational burden (TMB >=10 mutations/ MB).

Exclusion Criteria:
• Any significant cardiovascular events within 6 months prior to study entry
• Pulmonary embolism within 30 days prior to study entry
• Previous treatment with atezolizumab or another programmed death-1 (PD-1)/PD-L1 inhibitor

Phase II
Multiple Tumor Types
Rachel Sanborn, M.D.
Melissa Pomeroy
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Newberg
  • Oncology and Hematology Care Southeast
  • Oncology and Hematology Care Westside