Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

• Status: Recruiting
• Trial end date: 2025-01-07
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Doxorubicin; Ipilimumab; Liposomal doxorubicin; Nivolumab

Criteria

Inclusion Criteria:

• Signed written informed consent

• 18 years or older at moment of inclusion;

• Female gender;

• WHO performance status 0 or 1;

• Resectable primary breast cancer stage I-III. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.

• The tumors must be:

• at least 10 mm (minimum cT1c) as determined by MRI

• TNBC defined as ER<10%, HER2-negative OR luminal B defined as ER≥10%, HER2-negative with either grade 3 or Ki67≥20%. HER2 negative is defined as an IHC score of <2 or 2+ with a negative ISH.

• For cohort 3B: N0 status

Exclusion Criteria:

• evidence or suspicion of metastatic disease. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures;

• evidence of a concurrent contralateral or ipsilateral second primary infiltrating breast cancer. Evaluation of the presence of a concurrent second primary breast cancer may include mammography, breast ultrasound and/or MRI breast;

• other malignancy except carcinoma in situ and basal-cell and squamous carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiotherapy

• previous radiation therapy or chemotherapy;

• prior treatment with checkpoint inhibitors (including anti- PD1, -PD-L1, -CTLA-4);

• concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug;