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MOLECULARLY TARGETED: TMB-high: >/=2nd Line: MY PATHWAY- TMB

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

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Malignancy

Breast cancer, Endometrial, Uterine, Ovarian, Cervical, Colon, colorectal, biliary, gastric, esophageal, sarcoma, pancreatic, bladder, prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2ndline or later

Investigational Agent

Atezolizumab

Drug Class

PD-L1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech

Path

Solid tumor

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)
ADVANCED TUMORS: PHASE 1 (ESCALATION): PD-1 naive or experienced; TIM3+NIVOLUMAB: CA031002

A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors

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Malignancy

Renal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

BMS 986258

Drug Class

TIM-3 antibody

PI

Dan Vaena, MD

Sponsor

Bristol Myers Squibb

Path

Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any

Key Eligibility Criteria Details
  • 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
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