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

Sponsor
The Netherlands Cancer Institute
Study ID
NCT06342037
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 12, 2024
Status verified
Apr 2024
Primary completion
Apr 1, 2026
Completion
Apr 1, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tiragolumab and atezolizumab
    Tiragolumab 600mg and atezolizumab 1200 mg, both every three weeks
  • Experimental: Tiragolumab and ipilimumab
    Tiragolumab 600mg every 3 weeks and ipilimumab 1mg/kg every 3 weeks for the first 4 cycles
  • Experimental: Tiragolumab, atezolizumab and ipilimumab
    Tiragolumab 600mg and atezolizumab 1200mg both every 3 weeks, plus ipilimumab 1mg/kg every 3 weeks for the first 4 cycles

Primary Outcome Measure

PFS-12 [ Time Frame: Assessed at 12 weeks ]

Central Contacts

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