Ongoing Vaccine Trials in Breast and Ovarian Cancer

To date, sipuleucel-T remains the first and only FDA-approved cancer treatment vaccine on the market and is used for some men with metastatic prostate cancer.3 Best estimates of clinical availability of a vaccine to treat breast and ovarian cancer range from 5 to 10 years.

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Genentech, Inc., and Galena Biopharma are enrolling patients with HER2-positive breast cancer for 2 phase 2 trials ( Identifiers: NCT02297698 and NCT01570036) of the nelipepimut-S vaccine with trastuzumab vs trastuzumab plus GM-CSF alone in to prevent recurrence in the adjuvant setting.4

The National Cancer Institute is conducting a phase 2 study ( Identifier: NCT02636582) of nelipepimut-S plus GM-CSF in women with DCIS.

The National Cancer Institute is recruiting for a phase 1 trial ( Identifier: NCT01730118) of an adenoviral transduced autologous DC vaccine expressing human HER2/neu (AdHER2/neu) in adults with tumors — including breast, adenocarcinomas, and metastatic solid tumors characterized by HER2/neu expression — with 1 to 3-positive HER2/neu expression.

The University of Connecticut also recently announced open accrual of patients for “the world’s first personalized genomics-driven ovarian cancer vaccine clinical trial” using OncoImmune, which will be individualized for each patient.5

The phase 1 study ( Identifier: NCT02933073) will enroll up to 15 women with stage III/IV ovarian cancer in clinical remission after standard of care, with monitoring up to 5 years post-vaccination.


  1. McCarthy EF. The toxins of William B. Coley and the treatment of bone and soft-tissue sarcomas. Iowa Orthop J. 2006;26:154-8.
  2. Knutson KL, Kalli KR, Block MS, et al. Robust generation of T cell immunity to HER2 in HER2+ breast cancer patients with a degenerate subdominant HLA-DR epitope vaccine. Poster presented at: San Antonio Breast Cancer Symposium; December 10, 2015; San Antonio, Texas.
  3. PROVENGE (sipuleucel-T). Prescribing information. CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf. US Food and Drug Administration website. Accessed May 2017.
  4. Galena Biopharma reports positive outcome from the data safety monitoring board on the two NeuVax (nelipepimut-S) clinical trials in combination with trastuzumab [news release]. San Ramon, CA: Galena Biopharma; February 6, 2016. Accessed May 2017.
  5. Woods L. Recruitment begins for world’s first ovarian cancer vaccine trial [news release]. Storrs, CT: University of Connecticut; April 20, 2017. Accessed May 2017.