Amarex Statistical Analysis Plan for CD07 ( TNBC )
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Posted On: 07/05/2025 2:11:42 AM
Amarex Statistical Analysis Plan for CD07 ( TNBC ) with carboplatin. PDF is 38 pages.
Protocol Jan. 2021
Statistical Analysis Plan Aug. 2021
Only pulled from it all CTC & PD-L1 references.
Maybe something helpful, maybe not....
Under #3, Treatment Period:
Additionally, a blood sample will be collected prior to treatment administration for CTCs PD-L1/CCR5, and CTC - CAMLs analysis.
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2.4.3 Exploratory Outcome Measures
• Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as
CAMLs and correlate with therapeutic benefit (PFS); and
• Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression.
__
8.3.6.1 Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such
as CAMLs and correlate with therapeutic benefit (PFS) Immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs will be related to PFS using Cox regression.
8.3.6.2 Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression
CCR5 expression (CTCs, CAMLs) and PD- L1 expression will be correlated using logistic
regression.
__
[13] Blood sample collection for CTC and PDL-1 analysis to be taken prior to the treatment administration at baseline (C1D1), on Day 1 (CXD1) of each subsequent cycle, and at the end of treatment (EOT).
[14] Blood sample collection for CTC and CAMLs analysis to be taken prior to treatment administration at baseline (C1D1), on Day 1 (CXD1) of each subsequent cycle, and at the end of treatment (EOT).
Protocol Jan. 2021
Statistical Analysis Plan Aug. 2021
Only pulled from it all CTC & PD-L1 references.
Maybe something helpful, maybe not....
Under #3, Treatment Period:
Additionally, a blood sample will be collected prior to treatment administration for CTCs PD-L1/CCR5, and CTC - CAMLs analysis.
__
2.4.3 Exploratory Outcome Measures
• Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as
CAMLs and correlate with therapeutic benefit (PFS); and
• Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression.
__
8.3.6.1 Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such
as CAMLs and correlate with therapeutic benefit (PFS) Immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs will be related to PFS using Cox regression.
8.3.6.2 Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression
CCR5 expression (CTCs, CAMLs) and PD- L1 expression will be correlated using logistic
regression.
__
[13] Blood sample collection for CTC and PDL-1 analysis to be taken prior to the treatment administration at baseline (C1D1), on Day 1 (CXD1) of each subsequent cycle, and at the end of treatment (EOT).
[14] Blood sample collection for CTC and CAMLs analysis to be taken prior to treatment administration at baseline (C1D1), on Day 1 (CXD1) of each subsequent cycle, and at the end of treatment (EOT).
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