Combination Immunotherapy Treatment for Locally Advanced Unresectable or Metastatic, PD-L1 Negative (CPS<10), gBRCA Negative, Triple Negative Breast Cancer Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy

Conditions

• Triple-Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 72 Years

Healthy Volunteers

Not accepted

Interventions

• BreakVax — DRUG
  BreakVax (BB-101) is an investigational, personalized peptide-based cancer immunotherapy designed to stimulate patient-specific antitumor T-cell responses. For each patient, tumor tissue undergoes integrated genomic, transcriptomic, and proteomic analysis to identify tumor-associated antigens (TAAs) and tumor-specific neoantigens (TSAs). A proprietary selection algorithm prioritizes peptides predicted to be presented by the patient's HLA molecules and selectively expressed or overexpressed in tumor tissue. The resulting individualized peptide pools are manufactured, formulated with adjuvants (Montanide ISA 51 and Poly-ICLC), and administered subcutaneously
• Ipilimumab 2.5 mg — DRUG
  A local dendritic cell adjuvant injected adjacent to the BreakVax site to promote antigen presentation and T-cell priming
• Pembrolizumab — DRUG
  To mitigate PD-1-mediated T-cell exhaustion and sustain effector function
• Standard-of-care chemotherapy — DRUG
  May promote immunogenic cell death, increase antigen release and modulate the tumor microenvironment
• Losartan and aspirin — DRUG
  Have been associated in preclinical and translational studies with modulation of stromal architecture, vascular normalization, and reduction of tumor-associated immunosuppressive signaling

Study Details

The objective of this study is to evaluate the safety, feasibility, and preliminary antitumor activity of this multi-component immunotherapy strategy in patients with advanced solid tumors. The study is designed to assess whether coordinated enhancement of antigen-specific T-cell priming and tumor microenvironment modulation can improve immune-mediated tumor control. In this study, BreakVax with adjuvants (Montanide and Poly-ICLC) is administered in combination with: 1. Low-dose subcutaneous ipilimumab at the injection site as a dendritic cell adjuvant to enhance local dendritic cell-mediated T-cell priming; 2. Pembrolizumab to mitigate PD-1-mediated T-cell exhaustion and sustain effector function; 3. Standard-of-care chemotherapy, which may promote immunogenic cell death, increase antigen release and modulate the tumor microenvironment; and 4. Losartan and aspirin, which have been associated in preclinical and translational studies with modulation of stromal architecture, vascular normalization, and reduction of tumor-associated immunosuppressive signaling. The study consists of two components: a Safety Lead-in Cohort and a randomized combination therapy cohort. The Safety Lead-in Cohort is designed to evaluate safety and tolerability of the study combination and to characterize dose-limiting toxicities (DLTs). The randomized combination therapy cohort portion is designed to evaluate the antitumor activity of the study combination compared with standard-of-care (SOC) chemotherapy of physician's choice, as measured by objective response rate (ORR), and to evaluate disease control rate (DCR) in patients who receive the study combination following progression on SOC chemotherapy.

Key Dates

First listed

Aug 13, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

10 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BreakVax Arm
  A treatment cycle is defined as 21 days. BreakVax Arm: BreakVax, in combination with its adjuvants and low-dose subcutaneous ipilimumab (as a local dendritic cell adjuvant) will be administered on Day 1 of Cycles 1, 2, and 3. Thereafter, BreakVax will be administered on Day 1 of every even cycle (i.e. cycles 4, 6, 8, etc.) until disease progression per iRECIST or other discontinuation criteria. In addition to BreakVax: * Losartan will be administered orally once daily throughout treatment. * Chemotherapy of physician's choice will be administered per the selected regimen within each cycle. * Aspirin will be administered orally once daily, except on Days 1, 2, and 3 of cycles in which BreakVax is administered. * Pembrolizumab will be initiated on Day 10 of Cycle 4 and will thereafter be administered on Day 10 of every even-numbered cycle (i.e., Cycles 4, 6, 8, etc.) until disease progression or discontinuation
• Active Comparator: Delayed BreakVax Arm
  Patients randomized to the Delayed BreakVax Arm will receive chemotherapy of physician's choice in each 21-day cycle until disease progression per iRECIST. Upon documented disease progression, patients will cross over to receive the full combination regimen, including BreakVax with adjuvants, low-dose subcutaneous ipilimumab (as a local dendritic cell adjuvant), pembrolizumab, losartan, aspirin, and chemotherapy of physician's choice, according to the BreakVax Arm schedule

Primary Outcome Measure

Immune-related Objective Response Rate (irORR) per iRECIST Assessed by Independent Review Committee [ Time Frame: From start of assigned treatment through disease progression; for the Delayed BreakVax Arm, through progression on chemotherapy before crossover to BreakVax, up to 2 years ]

Locations (1)

Find similar trials in Miami, FL

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