Phase 2 Pembrolizumab/Chemotherapy Trial With MO-03 for Early-Stage TNBC
Summary
NCT07552181 is a Phase 2 clinical trial registration for early-stage triple-negative breast cancer combining pembrolizumab, standard chemotherapy, and the live biotherapeutic product MO-03. The single-arm, single-site trial will enroll 50 participants who will receive MO-03 orally twice daily, pembrolizumab 200mg every 3 weeks, and concurrent chemotherapy until the day prior to surgery. Patients will undergo 2-week post-surgery follow-up and annual survival follow-up for 5 years. The registration provides public access to study parameters and eligibility criteria without creating compliance obligations.
“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.”
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What changed
NCT07552181 is a Phase 2 clinical trial registration describing a study combining pembrolizumab and standard chemotherapy with the live biotherapeutic product MO-03 in patients with early-stage triple-negative breast cancer. The trial will enroll 50 participants at a single site, with MO-03 administered orally twice daily at 4 x 10e9 CFU per capsule, pembrolizumab at 200mg every 3 weeks, and chemotherapy according to standard regimens. Treatment continues until the day prior to surgery, followed by 2-week post-surgery visit and annual survival follow-up for 5 years.
Pharmaceutical sponsors and clinical investigators monitoring the TNBC treatment landscape may find this trial relevant as an emerging combination-therapy study. The registration does not create regulatory obligations but provides protocol details and eligibility criteria for healthcare providers considering trial referrals.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product, MO-03, in Patients With Early Stage Triple Negative Breast Cancer
Phase 2 NCT07552181 Kind: PHASE2 Apr 27, 2026
Abstract
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.
Conditions: TNBC - Triple-Negative Breast Cancer, TNBC, Early Stage Triple-Negative Breast Carcinoma
Interventions: Live biotherapeutic product: MO-03 1 capsule PO BID
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