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Table 1 Cohorts 1–6 – Advanced disease cohorts and defined standard of care ICI-containing treatment regimens

From: The MITRE trial protocol: a study to evaluate the microbiome as a biomarker of efficacy and toxicity in cancer patients receiving immune checkpoint inhibitor therapy

Cohort

Disease

Regimens

Primary outcome measure

Cohort 1

Unresectable AJCC stage 3 or 4 melanoma

Anti-PD-1 monotherapy (nivolumab or pembrolizumab)

1 year PFS

Cohort 2

Unresectable AJCC stage 3 or 4 melanoma

Ipilimumab+nivolumab

1 year PFS

Cohort 3

Advanced renal cell carcinoma

Anti-PD-(L)1 + kinase inhibitor

1 year PFS

Cohort 4

Advanced renal cell carcinoma

Ipilimumab+nivolumab

1 year PFS

Cohort 5

Advanced NSCLC

Anti-PD-(L)1 monotherapy in the first-line setting

1 year PFS

Cohort 6

Advanced NSCLC

Anti-PD-(L)1 + chemotherapy ± antiangiogenic in the first-line setting

1 year PFS

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BMC Cancer

ISSN: 1471-2407

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