Phase I clinical trial of a five-peptide cancer vaccine combined with cyclophosphamide in advanced solid tumors

Mutsunori Murahashi, Yasuki Hijikata, Kazunari Yamada, Yoshihiro Tanaka, Junji Kishimoto, Hiroyuki Inoue, Tomotoshi Marumoto, Atsushi Takahashi, Toshihiko Okazaki, Kazuyoshi Takeda, Masakazu Hirakawa, Hiroshi Fujii, Shinji Okano, Masaru Morita, Eishi Baba, Kazuhiro Mizumoto, Yoshihiko Maehara, Masao Tanaka, Koichi Akashi, Yoichi NakanishiKoji Yoshida, Takuya Tsunoda, Kazuo Tamura, Yusuke Nakamura, Kenzaburo Tani

Research output: Contribution to journalArticlepeer-review

46 Citations (Scopus)


We designed a phase I trial to investigate the safety, immune responses and clinical benefits of a five-peptide cancer vaccine in combination with chemotherapy. Study subjects were patients positive for HLA-A2402 with locally advanced, metastatic, and/or recurrent gastrointestinal, lung or cervical cancer. Eighteen patients including nine cases of colorectal cancer were treated with escalating doses of cyclophosphamide 4 days before vaccination. Five HLA-A2402-restricted, tumor-associated antigen (TAA) epitope peptides from KOC1, TTK, URLC10, DEPDC1 and MPHOSPH1 were injected weekly for 4 weeks. Treatment was well tolerated without any adverse events above grade 3. Analysis of peripheral blood lymphocytes showed that the number of regulatory T cells dropped from baseline after administration of cyclophosphamide and confirmed that TAA-specific T cell responses were associated significantly with longer overall survival. This phase I clinical trial demonstrated safety and promising immune responses that correlated with vaccine-induced T-cell responses. Therefore, this approach warrants further clinical studies.

Original languageEnglish
Pages (from-to)48-58
Number of pages11
JournalClinical Immunology
Publication statusPublished - May 1 2016

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology


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