Immune induction strategies to improve response to immune checkpoint blockade in triple negative breast cancer (TNBC) patients: the TONIC-2 trial

Conditions

Triple negative breast cancer (TNBC) with metastatic disease

Brief summary

Progression-free survival as measured by the proportion of patients free of progression after 6 cycles of nivolumab (PFS1: time from randomization to tumor progression or death from any cause) according to RECIST1.1

Detailed description

Response as measured by the objective response rate (ORR: complete responses or partial responses) according to iRECIST and RECIST1.1, Clinical benefit as measured by the clinical benefit rate (CBR) according to RECIST 1.1 and iRECIST, PFS1 according to RECIST 1.1 and iRECIST, Overall survival (OS: time from nivolumab initiation to death from any cause), Percentage of patients with toxicity (CTCAE v5.0) and immune-related toxicity, PFS as measured by the proportion of patients free of progression after 6 cycles of nivolumab (PFS2: time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 and iRECIST will be used

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Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGCisplatine 1 mg/ml PCH

DRUGconcentraat voor oplossing voor infusie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival as measured by the proportion of patients free of progression after 6 cycles of nivolumab (PFS1: time from randomization to tumor progression or death from any cause) according to RECIST1.1	—

Secondary

Measure	Time frame
Response as measured by the objective response rate (ORR: complete responses or partial responses) according to iRECIST and RECIST1.1, Clinical benefit as measured by the clinical benefit rate (CBR) according to RECIST 1.1 and iRECIST, PFS1 according to RECIST 1.1 and iRECIST, Overall survival (OS: time from nivolumab initiation to death from any cause), Percentage of patients with toxicity (CTCAE v5.0) and immune-related toxicity, PFS as measured by the proportion of patients free of progression after 6 cycles of nivolumab (PFS2: time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 and iRECIST will be used	—

Measure

Time frame

Response as measured by the objective response rate (ORR: complete responses or partial responses) according to iRECIST and RECIST1.1, Clinical benefit as measured by the clinical benefit rate (CBR) according to RECIST 1.1 and iRECIST, PFS1 according to RECIST 1.1 and iRECIST, Overall survival (OS: time from nivolumab initiation to death from any cause), Percentage of patients with toxicity (CTCAE v5.0) and immune-related toxicity, PFS as measured by the proportion of patients free of progression after 6 cycles of nivolumab (PFS2: time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 and iRECIST will be used

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Countries

Netherlands

Outcome results

None listed