Window of Opportunity Study of Intratumoral CD40 Agonist (Mitazalimab) With or Without PD-1 Inhibitor (Nivolumab) in Patients With Resectable Breast Cancer (WINIT-BC)
Jennifer Zhang
Summary
The goal of this clinical trial is to study the safety, feasibility, histologic and immunological effects of Mitazalimab, a CD40 agonistic antibody, when administered either alone or in combination with PD-1 inhibition prior to surgical resection. The investigator hypothesizes that preoperative administration of CD40 agonist with or without PD-1 inhibitor intratumorally will demonstrate an acceptable safety profile, will not result in an unplanned delay in surgery, and will lead to increased immune activation. Subjects will receive a single intratumoral dose of CD40 agonist with or without PD-1 inhibitor 7 or more days prior to surgery and will be followed for safety, feasibility, immune, and pathologic responses.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed and dated written IRB-approved informed consent. 2. Age ≥18 years. 3. Body weight \> 40kg 4. Stage I-III or recurrent resectable breast cancer to be treated with curative-intent 5. Planning to undergo upfront surgery as part of routine clinical care 6. Discussion with the treating or study medical oncologist re: the potential of sending an Oncotype evaluation (if ER+HER2-) on the core needle biopsy sample 7. Availability of the core needle biopsy sample for correlative studies 8. Surgery to be performed at a University of Pennsylvania Hospital 9. Life expectancy…
Interventions
- DrugIntratumoral Mitazalimab
Intratumoral agonistic CD40
- DrugIntratumoral Nivolumab
Checkpoint inhibitor
Location
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania