Tests immunotherapy combinations for advanced triple-negative breast cancer
Tests tiragolumab with atezolizumab or ipilimumab in adults with advanced breast cancer.
Plain-language title generated from the registry record
Registry title: NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 2
Where in Netherlands
- Antoni van LeeuwenhoekAmsterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT06342037
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial
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.
Inclusion: Metastatic or incurable locally advanced triple negative breast cancer with confirmation of Estrogen receptor (ER) and Human Epidermal growth factor Receptor 2 (HER2) negativity (ER <10%, HER2 IHC 0, 1+ or 2+ with no amplification) on a histological biopsy of a metastatic lesion; Patients with PD-L1 negative disease determined using the Combined Positivity Score (CPS<10) (Dako 22C3 IHC) OR previously treated with anti-PD(L)1 in the (neo)adjuvant or metastatic setting (irrespective of PD-L1 status); Metastatic lesion accessible for histological biopsy; 18 years or older; World Health Organisation (WHO) performance status of 0 or 1; Maximum of three lines of chemotherapy, including antibody-drug conjugates and Poly-ADP Ribose Polymerase (PARP)-inhibitors, for metastatic disease and with evidence of progression of disease; Measurable or evaluable disease according to RECIST1.1; Disease Free Interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year. This does not apply to patients with de novo metastatic disease or patients who did not receive (neo)adjuvant chemotherapy; Adequate bone marrow, kidney and liver function.
Exclusion: History of having received other anticancer therapies within 2 weeks of start of the study drug; Prior treatment with an anti-CTLA4 or anti-TIGIT antibody; Administration of live vaccine within 30 days of planned start of study therapy; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris; History of leptomeningeal disease localization; History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins; History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mg daily prednisone equivalents) or chronic infections; Active other cancer; Positive test for hepatitis B, hepatitis C, HIV and/or Epstein Barr virus (EBV); History of uncontrolled serious medical or psychiatric illness; Symptomatic brain metastases (subjects with asymptomatic brain metastases are eligible if these are free of progression for at least 4 weeks); Known hypersensitivy to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulation; Current pregnancy pregnancy or breastfeeding.