NCT06342037

NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Tiragolumab	600mg every 3 weeks (Q3W)
DRUG	Atezolizumab	1200mg every 3 weeks (Q3W)
DRUG	Ipilimumab	1 mg/kg, maximum of 4 cycles

Timeline

• Start date: 2024-06-12
• Primary completion: 2026-04-01
• Completion: 2030-04-01
• First posted: 2024-04-02
• Last updated: 2024-09-19

Locations

1 site across 1 country: Netherlands