RecruitingPhase 2NCT06342037

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

Sponsor

The Netherlands Cancer Institute

Enrollment

60 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer

Summary

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

Min Age: 18 Years

Inclusion Criteria9

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
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 Criteria13

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.

Interventions

DRUGTiragolumab

600mg every 3 weeks (Q3W)

DRUGAtezolizumab

1200mg every 3 weeks (Q3W)

DRUGIpilimumab

1 mg/kg, maximum of 4 cycles

Locations(1)

Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06342037

Related Trials

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

NCT0342400545 locations

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

NCT0708576735 locations