Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer
Yuan Yuan
Summary
This is a single-arm and single site phase II trial combination of chemotherapy and pembrolizumab with LBP MO-03 in 50 trial participants with early triple negative breast cancer. MO-03 will be given at a dose of 4 x 10e9 CFU per capsule, 1 capsule taken orally twice daily. Patients will receive standard of care pembrolizumab 200 mg every 3 weeks in concurrent with a regimen of chemotherapy. Please refer to Table 2 for a summary of the chemo-immunotherapy with pembrolizumab containing regimens. Patients will continue to take MO-03 up until the day prior to surgery (lumpectomy or mastectomy). Post-surgery, patients will come in for a 2-week follow-up and then enter survival follow-up annually for 5 years.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Female or male age ≥ 18 years of age. * Patients with high-risk early stage triple negative breast cancer. Triple negative status will be defined as ER≤10%, PR≤10%, HER2 negative (by FISH) per ASCO-CAP guidelines. * Clinically staging T1c any N M0 or any T N1-3 M0. * Willing to provide FFPE from baseline standard of care biopsy and post-treatment residual tumor at the time of surgery. * ECOG 0-1 * Patients must have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study treatment. * For patients who wil…
Interventions
- DrugLive biotherapeutic product: MO-03 1 capsule PO BID
Live biotherapeutic product: MO-03 1 capsule PO BID + standard of care pembrolizumab and carbo-docetaxel or carbo-paclitaxel followed by Adriamycin cyclophosphamide
Locations (3)
- Cedars-Sinai Medical Center Beverly HillsBeverly Hills, California
- CS Cancer at Valley Oncology Medical GroupTarzana, California
- Hunt Cancer Institute, an Affiliate of CS CancerTorrance, California