This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer.
Programmed cell death protein 1 (PD1) -blockade is currently being approved for the neoadjuvant treatment of early TNBC as well as for first-line treatment in combination with chemotherapy for patients with Programmed cell death-ligand 1 (PD-L1) -positive TNBC with metastatic disease. However, response rates are modest, responses are not always durable and PD-L1 is a suboptimal biomarker to select patients for this regimen. Therefore, the overarching goal of this TONIC-3 study is to develop novel immunomodulatory strategies for patients with advanced TNBC making use state-of-the-art research tools to better understand the underlying cancer-immune interactions of this disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
600mg every 3 weeks (Q3W)
1200mg every 3 weeks (Q3W)
1 mg/kg, maximum of 4 cycles
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands
RECRUITINGPFS-12
Progression-free survival rate as measured by the proportion of patients free of progression after 12-weeks of treatment
Time frame: Assessed at 12 weeks
Incidence of adverse events
Number of patients with adverse events as measured according to CTCAE v5.0
Time frame: Assessed until 90 days after the last dose of study treatment or until initiation of new anti-cancer therapy, whichever occurs first
Objective response rate
Complete response or partial response according to Response Evaluation Criteria in Solid Tumours in cancer immunotherapy trials (iRECIST) and Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)
Time frame: Assessed at week 6, week 12 and every 12 weeks thereafter; assessed up to 120 months
Clinical benefit rate
Complete response, partial response or stable disease for at least 24 weeks according to iRECIST and RECIST1.1
Time frame: Assessed at week 6, week 12 and every 12 weeks thereafter; assessed up to 120 months
Progression-free survival
Time from randomization to data of first tumor progression
Time frame: Assessed at week 6, week 12 and every 12 weeks thereafter; median 12 months
Overall survival
Time from therapy initiation to death from any cause
Time frame: Assessed monthly until date of death; median 12 months
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