Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Invasive Breast Carcinoma
• Metastatic Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo tumor biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood and urine sample collection
• Carboplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Durvalumab — BIOLOGICAL
  Given IV
• Gemcitabine Hydrochloride — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nab-paclitaxel — DRUG
  Given IV
• Personalized Synthetic Long Peptide Vaccine — BIOLOGICAL
  Given SC
• Poly ICLC — DRUG
  Given SC
• Sacituzumab Govitecan — BIOLOGICAL
  Given IV
• Tremelimumab — BIOLOGICAL
  Given IV

Study Details

This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.

Key Dates

Start date

Apr 13, 2021

Status verified

Apr 2026

Primary completion

Dec 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (neoantigen vaccine, durvalumab, nab-paclitaxel)
  See Detailed Description.
• Active Comparator: Arm II (durvalumab, nab-paclitaxel)
  See Detailed Description.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From initiation of Part B to progression or death, assessed at 6 and 12 months ]

Locations (30)

Find similar trials in Orange, CA

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