Pre-operative phase II trial for breast cancer with nivolumab in combination with novel IO

KI-AV0 sites90 target enrollmentFebruary 26, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: MedDRA version: 21.1Level: LLTClassification code 10006188Term: Breast cancer female NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sponsor: KI-AV
Enrollment: 90
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

February 26, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

KI-AV

•Signed written informed consent
•18 years or older at moment of inclusion;
•Female and male 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 (cohort 3B, 4B and 5B: PET\-CT mandatory).
•Patients indicated for neoadjuvant chemotherapy will also be eligible, whereby a new dedicated biopsy is performed before the beginning of the chemotherapy. Adjuvant systemic treatment is allowed if indicated according to local guidelines.
•The tumors must be:
•o at least 5 mm (minimum cT1b) as determined by MRI
•o TNBC defined as ER\<10%, HER2\-negative OR luminal B defined as ER\=10%, HER2\-negative with either Ki67\=20% or PR \=20% OR grade 3\. HER2 negative is defined as an IHC score of \<2 or 2\+ with a negative ISH.
•oFor TNBC patients: TIL\=5%

•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;
•other prior invasive malignancy 1\) in the breast or 2\) localized in the near proximity of the breast, that was treated with radiotherapy at the localization of the new breast tumor;
•Concurrent ipsilateral or contralateral disease of the primary or a secondary tumor is allowed, as long as the other lesions is not a distant metastasis.
•Locoregional recurrences are not allowed. Second primary tumors are allowed in the study;
•occult breast cancer;
•previous anti\-cancer hormone therapy or chemotherapy;
•prior treatment with checkpoint inhibitors (including anti\- PD1, \-PD\-L1, \-CTLA\-4, \-LAG3\);
•concurrent anti\-cancer treatment, neoadjuvant therapy or another investigational drug;