Actively Recruiting
Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients
Led by The Netherlands Cancer Institute · Updated on 2022-03-22
52
Participants Needed
1
Research Sites
355 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.
CONDITIONS
Official Title
Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic or incurable locally advanced triple negative breast cancer (ER < 10%, HER2 IHC 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. Treatment with low-dose doxorubicin in the palliative setting is not allowed.
- WHO performance status of 0 or 1
- Measurable or evaluable disease according to RECIST 1.1
- Disease Free Interval longer than 1 year
- Subjects with brain metastases are eligible if these are not symptomatic and free of progression of at least 4 weeks
- A maximum dosage of 360 mg/m2 of anthracyclines and no previous anthracycline-related cardiac toxicity. In case of radiation in the cardiac area, hypertension, diabetes mellitus or hypercholesterolemia, the left ventricular ejection fraction must be 50% or higher.
- Adequate bone marrow, kidney and liver function
You will not qualify if you...
- Uncontrolled intercurrent illness including 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 mg daily prednisone equivalents) or chronic infections
- Prior treatment with immune checkpoint inhibitors
- Active other cancer
- History of uncontrolled serious medical or psychiatric illness
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
Research Team
M
Marleen Kok, MD
CONTACT
L
Leonie Voorwerk, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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