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

NCT06342037

RecruitingPhase 2

Sponsor: The Netherlands Cancer Institute

Conditions: Metastatic Breast Cancer

Interventions: Tiragolumab, Atezolizumab, Ipilimumab

Countries: Netherlands

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris
* Symptomatic brain metastases (subjects with asymptomatic brain metastases are eligible if these are free of progression for at least 4 weeks)
* History of leptomeningeal disease localization
* History of having received other anticancer therapies within 2 weeks of start of the study drug
* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivy to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulation
* History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (\>10 mg daily prednisone equivalents) or chronic infections.
* Prior treatment with an anti-CTLA4 or anti-TIGIT antibody.
* Administration of live vaccine within 30 days of planned start of study therapy.
* 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
* Current pregnancy pregnancy or breastfeeding.

Locations (1)

Amsterdam, North Holland, Netherlands