Immune induction strategies to improve response to immune checkpoint blockade in triple negative breast cancer (TNBC) patients: the TONIC-2 trial

Phase 2

Recruiting

Conditions: triple negative
Breast cancer
10006291

Registration Number: NL-OMON54994

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

• Metastatic or incurable locally advanced triple negative breast cancer (ER <
10%, HER2 0,1 or 2 with no amplification)
• Metastatic lesion accessible for histological biopsy
• 18 years or older
• Maximum of three lines of chemotherapy for metastatic disease and with
evidence of progression of disease.
• WHO performance status of 0 or 1
• Measurable or evaluable disease according to RECIST 1.1
• 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.
• Subjects with brain metastases are eligible if these are not symptomatic and
free of progression of at least 4 weeks

Exclusion Criteria

• uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris
• known history of leptomeningeal disease localization
• history of having received other anticancer therapies within 2 weeks of start
of the study drug
• history of immunodeficiency, autoimmune disease, conditions requiring
immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections.
• prior treatment with immune checkpoint inhibitors.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>progression-free survival as measured by the proportion of patients free of<br /><br>progression after 6 cycles of nivolumab (PFS1: time from randomization to tumor<br /><br>progression or death from any cause) according to RECIST1.1</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Response as measured by the objective response rate (ORR: complete responses<br /><br>or partial responses) according to iRECIST and RECIST1.1<br /><br>• Clinical benefit as measured by the clinical benefit rate (CBR) according to<br /><br>RECIST 1.1 and iRECIST.<br /><br>• PFS1 according to RECIST 1.1 and iRECIST.<br /><br>• Overall survival (OS: time from nivolumab initiation to death from any cause)<br /><br>• Percentage of patients with toxicity (CTCAE v5.0) and immune-related toxicity<br /><br>• PFS as measured by the proportion of patients free of progression after 6<br /><br>cycles of nivolumab (PFS2: time from nivolumab initiation to tumor progression<br /><br>or death from any cause). Progression as defined by RECIST 1.1 and iRECIST will<br /><br>be used. </p><br>