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
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer, Endometrial, Uterine, Ovarian, Cervical, Colon, colorectal, biliary, gastric, esophageal, sarcoma, pancreatic, bladder, prostate
Stage 4
Phase 2
Open to Enrollment
2ndline or later
Atezolizumab
PD-L1 inhibitor
Ari VanderWalde, MD
Genentech
Solid tumor
- 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)
A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors
VIEW TRIAL ON CLINICALTRIALS.GOVRenal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)
Stage 4
Phase 1
Open to Enrollment
2nd line or greater
BMS 986258
TIM-3 antibody
Dan Vaena, MD
Bristol Myers Squibb
Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any
- ECOG PS 0-1
- No active CNS disease (controlled brain mets are allowed)
- Must have one of the five malignancies below
- Clear-cell RCC
- Triple-negative Breast Cancer
- Squamous cell carcinoma of the head and neck
- Colorectal cancer
- Non-small cell lung cancer
- No other malignancies within 2 years
- No active, known, or suspected autoimmune disease (except asthma, vitiligo, T1DM, hypothyroidism, Graves disease, or psoriasis not requiring treatment)
- No severe autoimmune reactions to immunotherapy
- No need for active steroid therapy
- No significant cardiac disease
- No chronic hepatitis
- No active interstitial lung disease
- RCC specific eligibility criteria
- Previously received one or two anti-VEGFR therapies
- No more than 3 total prior systemic tx in metastatic setting
- Must have evidence of progression on or after last treatment received and within 6 months of starting study
- CRC specific eligibilty criteria
- Must have received and progressed on at least 1 standard therapy for metastatic disease
- Must have known MSI status
- NSCLC specific eligibility criteria
- Must have progressed on or been refractory to platinum doublet
- Must have known EGFR, ALK, ROS1 status.
- Those with EGFR or ALK alterations must have previously received TKI therapy
- SCCHN specific eligibility criteria
- Not amenable ot local therapy with curative intent
- Must have progressed on or been intolerant of platinum containing regimen
- TNBC specific eligibility criteria
- Must have received and progressed on or been intolerant to at least 1 standard chemotherapy with anthracycline and taxane