Study Title
My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents
Malignancy
Breast cancer, Endometrial, Uterine, Ovarian, Cervical, Colon, colorectal, biliary, gastric, esophageal, sarcoma, pancreatic, bladder, prostate
Key Eligibility Criteria Details
- PD-L1 copy number gain/amplification (likely available on Foundation only)
- Patients with MSI-high
- Using either Foundation 1 or other NGS defined by a shift in the size of 30% or more loci
- Patients with dMMR
- Defined as loss of at least one of four markers (MLH1, MSH2, PMS2, MSH6)
- Patients with total mutational burden (TMB) high
- 10 mut/Mb per any CLIA certified test
- Patients with alterations in DNA proofreading/repair genes
- POLE mutations
- POLD1 mutations
- Mutations in genomic instability genes eg. MSH2, MLH1, MSH6
- If testing was not performed by Foundation Medicine, new pretreatment tissue sample is required. Tissue may be submitted within 4 weeks after enrollment
- No metastatic non-small cell lung cancer (no NSCLC)
- No metastatic urothelial carcinoma (no bladder cancer)
- No MSI-high colorectal cancer
- No history of autoimmune disease or immune deficiency
- No HIV/HBV/HCV
- No other malignancy within 5 years
- No need for immunosuppressive medications (including steroids)
Objective
Primary: ORR
Secondary: DCR, PFS, 1-yr OS