Actively Recruiting
NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial
Led by The Netherlands Cancer Institute · Updated on 2024-09-19
60
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic or incurable locally advanced triple negative breast cancer confirmed by biopsy showing Estrogen receptor less than 10% and HER2 negative status
- PD-L1 negative disease (Combined Positivity Score under 10) or prior treatment with anti-PD(L)1 therapy
- Metastatic lesion accessible for biopsy
- Age 18 years or older
- World Health Organization performance status of 0 or 1
- Maximum of three lines of chemotherapy for metastatic disease with evidence of disease progression
- Measurable or evaluable disease according to RECIST1.1
- Disease Free Interval longer than 1 year unless de novo metastatic or no prior (neo)adjuvant chemotherapy
- Adequate bone marrow, kidney, and liver function
You will not qualify if you...
- Uncontrolled illnesses including active infection, symptomatic heart failure, or unstable angina
- Symptomatic brain metastases (asymptomatic brain metastases must be stable for at least 4 weeks)
- History of leptomeningeal disease
- Other anticancer therapies within 2 weeks before study start
- Severe allergic reactions to similar antibodies or fusion proteins
- Known allergy to components of atezolizumab or tiragolumab
- History of immunodeficiency, autoimmune disease, or conditions requiring high-dose immunosuppression
- Prior anti-CTLA4 or anti-TIGIT antibody treatment
- Live vaccine within 30 days before study start
- Active other cancers
- Positive test for hepatitis B, hepatitis C, HIV, or Epstein Barr virus
- Uncontrolled serious medical or psychiatric illness
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
Research Team
M
Marleen Kok, MD
CONTACT
M
Manon de Graaf, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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