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Posted On: 08/22/2021 4:11:22 PM
Post# of 148893
Abridged version of mTNBC trial outcome measures.
Primary Outcome Measures:
Phase Ib: Maximum Tolerated Dose (MTD) of leronlimab
Phase II: Progression free survival (PFS)
Secondary Outcome Measures:
Phase I: Incidence of severity of adverse events (AEs)
Phase II: Progression Free Survival with detectable (PD-L1)
Phase II: Overall response rate
Phase II: Time to new metastases
Phase II: The change from baseline in circulating tumor cells (CTC) level
Phase II: Overall survival
Phase ll: incidence of adverse events (AE)
Other Outcome Measures:
Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit (PFS)
Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression.
Primary Outcome Measures:
Phase Ib: Maximum Tolerated Dose (MTD) of leronlimab
Phase II: Progression free survival (PFS)
Secondary Outcome Measures:
Phase I: Incidence of severity of adverse events (AEs)
Phase II: Progression Free Survival with detectable (PD-L1)
Phase II: Overall response rate
Phase II: Time to new metastases
Phase II: The change from baseline in circulating tumor cells (CTC) level
Phase II: Overall survival
Phase ll: incidence of adverse events (AE)
Other Outcome Measures:
Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit (PFS)
Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression.
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