Cycl2R, Remember that the mTNBC trial is phase1
Post# of 153820
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Posted On: 08/22/2021 2:42:35 PM
Cycl2R,
Remember that the mTNBC trial is phase1B/2, just transitioned to phase 2.
Outcomes measurements are very inclusive.
“ Phase Ib: Maximum Tolerated Dose (MTD) of leronlimab (PRO 140) when combined with carboplatin AUC5 [ Time Frame: Cycle 1 (21 days) ]
Phase II: Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first. [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Secondary Outcome Measures :
Phase I: The number, frequency, and severity of adverse events (AEs) collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC. [ Time Frame: From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug) ]
Phase II: Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1) [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)), and clinical benefit rate (CBR, defined as CR + PR + Stable Disease (SD)) in subjects with CCR5+ mTNBC treated with leronlimab (PRO 140) and carboplatin. [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: Time to new metastases (TTNM) [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: The change from baseline in circulating tumor cells (CTC) level in the peripheral blood. [ Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months. ]
Phase II: Overall survival defined as time in months from the date of first study treatment to the date of death; [ Time Frame: From Day 1 to death from any cause, assessed up to 2 years after completion of treatment. ]
Phase II: The number, frequency, and severity of AEs collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC. [ Time Frame: From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug) ]
Other Outcome Measures:
Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit (PFS) [ Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months. ]
Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression. [ Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months. ]
Remember that the mTNBC trial is phase1B/2, just transitioned to phase 2.
Outcomes measurements are very inclusive.
“ Phase Ib: Maximum Tolerated Dose (MTD) of leronlimab (PRO 140) when combined with carboplatin AUC5 [ Time Frame: Cycle 1 (21 days) ]
Phase II: Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first. [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Secondary Outcome Measures :
Phase I: The number, frequency, and severity of adverse events (AEs) collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC. [ Time Frame: From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug) ]
Phase II: Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1) [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)), and clinical benefit rate (CBR, defined as CR + PR + Stable Disease (SD)) in subjects with CCR5+ mTNBC treated with leronlimab (PRO 140) and carboplatin. [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: Time to new metastases (TTNM) [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: The change from baseline in circulating tumor cells (CTC) level in the peripheral blood. [ Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months. ]
Phase II: Overall survival defined as time in months from the date of first study treatment to the date of death; [ Time Frame: From Day 1 to death from any cause, assessed up to 2 years after completion of treatment. ]
Phase II: The number, frequency, and severity of AEs collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC. [ Time Frame: From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug) ]
Other Outcome Measures:
Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit (PFS) [ Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months. ]
Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression. [ Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months. ]
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