MOLECULARLY TARGETED: MSI-h/dMMR: myTACTIC Arm E(2)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors

Title
Genentech ML42439 (myTACTIC) MSI-h
Study Title

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors

Site Link
Malignancy
Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Any, but cannot have had prior anti-PD-1 or anti-PD-L1
Investigational Agent
Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)
Drug Class
PD-L1 inhibitor + chemotherapy
PI
Axel Grothey, MD
Sponsor
Genentech, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Microsatellite instability high (MSI-h) or deficient mismatch repair dMMR
  • No prior treatment with anti-PD1 or anti-PD-L1 agents
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
Objective
  • Primary-
    • ORR
  • Secondary
    • PFS
    • DoR
    • OS
    • PFS at various time points
    • DCR
    • Safety
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
MSI-h or dMMR
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
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