Actively Recruiting
Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO
Led by The Netherlands Cancer Institute · Updated on 2024-05-30
80
Participants Needed
1
Research Sites
691 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
To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with low dose doxorubicin or novel IO combinations can induce immune activation in early BC.
CONDITIONS
Official Title
Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Female gender
- 18 years or older at moment of inclusion
- WHO performance status 0 or 1
- Resectable primary breast cancer stage I-III with nodal status examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan
- Tumor size at least 10 mm as determined by MRI
- Tumor types: triple-negative breast cancer (TNBC) defined as ER <10%, HER2-negative OR luminal B defined as ER ≥10%, HER2-negative with Ki67 ≥20% or PR ≤20% OR grade 3
- HER2 negative defined as IHC score <2 or 2+ with a negative ISH
- For TNBC patients: tumor infiltrating lymphocytes (TIL) ≥5%
- For luminal B patients: TIL ≥1%
- For cohort 3B: N0 status, triple negative, and TIL ≥50%
- For cohort 4B: N0 status, TNBC, and TIL 30-49%
- For cohort 5B: N0 status, TNBC, and TIL ≥50%
- Patients with multifocal/multicentric breast cancer are eligible if triple negative breast cancer histology and sufficient TIL percentages are confirmed in all tumor lesions (30-49% in cohort 4B, ≥50% in cohort 5B)
You will not qualify if you...
- Evidence or suspicion of metastatic disease
- Evidence of a concurrent contralateral or ipsilateral second primary infiltrating breast cancer
- Other malignancies except carcinoma in situ and basal-cell or squamous carcinoma of the skin unless treated curatively ≥5 years ago without chemotherapy or radiotherapy
- Previous radiation therapy or chemotherapy
- Prior treatment with checkpoint inhibitors (anti-PD1, anti-PD-L1, or anti-CTLA-4)
- Concurrent anti-cancer treatment, neoadjuvant therapy, or use of another investigational drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NKI-AVL
Amsterdam, Netherlands, 1066CX
Actively Recruiting
Research Team
M
M Kok, MD
CONTACT
I
I Nederlof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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