RESULTS: Forty-nine patients with a median of 4 prior lines of chemotherapy received at least 1 vaccination. Twenty-eight patients completed the 3 vaccination regimen. Six patients received 1 six-month boost after the regimen, and one patient received 7 six-month boosts. No serious adverse reactions or dose-limiting toxicities were observed. The vaccine was well tolerated with dose level 2 as the recommended phase II dose. The most common related toxicity in all patients was injection site reactions (24%). Two patients had a partial response (PR), 14 had stable disease (SD), and 19 had progressive disease (PD). CONCLUSIONS: The study vaccine is safe, exhibits anti-tumor activity and shows preliminary indication that peptide vaccination may avoid therapeutic resistance and offer a promising alternative to monoclonal antibody therapies.
- Received December 7, 2018.
- Revision received January 18, 2019.
- Accepted February 21, 2019
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