New immunotherapy options for advanced triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the safety and efficacy of tiragolumab in combination with atezolizumab and/or ipilimumab for patients with advanced triple-negative breast cancer (TNBC). The study aims to develop novel immunomodulatory strategies by utilizing advanced research tools to better understand the cancer-immune interactions specific to TNBC. It is a single center, non-blinded, multi-cohort, non-comparative trial focusing on patients with metastatic or incurable locally advanced TNBC who have specific biomarker profiles. The trial seeks to improve response rates and durability of treatment outcomes in this challenging patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Antoni van Leeuwenhoek
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Marleen Kok, MD — Antoni van Leeuwenhoek
• Study coordinator: Marleen Kok, MD
• Email: m.kok@nki.nl
• Phone: +31205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.