Adaptive phase II randomized non-comparative trial of nivolumab after induction treatment in triple-negative breast cancer (TNBC) patients: TONIC-trial

Conditions

Triple negative breast cancer (TNBC) patients with metastatic disease

Brief summary

Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 will be used.

Detailed description

Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by modified RECIST 1.1 for immune-based therapeutics (iRECIST) will be used., Progression-free survival (=PFS2, time from nivolumab treatment initiation to tumor progression). Progression as defined by RECIST 1.1 and iRECIST will be used., Overall response rate ORR (complete response CR or partial response PR) according to RECIST 1.1 and iRECIST. ORR1 (relative to randomization) and ORR2 (relative to nivolumab initiation) will be used., Clinical benefit rate (CR+PR+stable disease ≥ 6 months and CR+PR+stable disease ≥ 3 months) according to RECIST 1.1 and iRECIST. CBR1 (relative to randomization) and CBR2 (relative to nivolumab initiation) will be used., Overall survival (OS, time from nivolumab initiation to death from any cause)., Percentage of patients with toxicity (classified according to CTCAE v4.0) and immune-related toxicity.

Related papers

No related papers found yet.

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 will be used.	—

Secondary

Measure	Time frame
Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by modified RECIST 1.1 for immune-based therapeutics (iRECIST) will be used., Progression-free survival (=PFS2, time from nivolumab treatment initiation to tumor progression). Progression as defined by RECIST 1.1 and iRECIST will be used., Overall response rate ORR (complete response CR or partial response PR) according to RECIST 1.1 and iRECIST. ORR1 (relative to randomization) and ORR2 (relative to nivolumab initiation) will be used., Clinical benefit rate (CR+PR+stable disease ≥ 6 months and CR+PR+stable disease ≥ 3 months) according to RECIST 1.1 and iRECIST. CBR1 (relative to randomization) and CBR2 (relative to nivolumab initiation) will be used., Overall survival (OS, time from nivolumab initiation to death from any cause)., Percentage of patients with toxicity (classified according to CTCAE v4.0) and immune-related toxicity.	—

Measure

Time frame

Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by modified RECIST 1.1 for immune-based therapeutics (iRECIST) will be used., Progression-free survival (=PFS2, time from nivolumab treatment initiation to tumor progression). Progression as defined by RECIST 1.1 and iRECIST will be used., Overall response rate ORR (complete response CR or partial response PR) according to RECIST 1.1 and iRECIST. ORR1 (relative to randomization) and ORR2 (relative to nivolumab initiation) will be used., Clinical benefit rate (CR+PR+stable disease ≥ 6 months and CR+PR+stable disease ≥ 3 months) according to RECIST 1.1 and iRECIST. CBR1 (relative to randomization) and CBR2 (relative to nivolumab initiation) will be used., Overall survival (OS, time from nivolumab initiation to death from any cause)., Percentage of patients with toxicity (classified according to CTCAE v4.0) and immune-related toxicity.

—

Countries

Netherlands

Outcome results

None listed