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A phase I study of combination immunotherapy with five peptides cocktail, CpG, and immune modulators for patients with advanced or metastatic colorectal cancer (A phase I study of combination immunotherapy with five peptides cocktail, CpG, and immune modulators for patients with advanced or metastatic colorectal cancer)

CpG trial (CpG trial)

10

1) Histologically confirmed colorectal cancer 2) Failure for standard therapy 3) Having HLA-A*2402 4) Surviving more than 3 months 5) More than 20 years 6) ECOG PS 0~2 7) having target lesion

Level 0, Level 1, Level 2, Level 3 3 patients' cohorts. 25 pts were enrolled, and 10 pts were gone to treatment. At level 0 and Level 1, there was no severe adverse event, and went to Level 2. In the level 2, one patient was suffered from progression of disease resulting to stop treatment. Hence, another one patient was enrolled to Level 2.

There was not severe adverse event in Level 0 to Level 2. The level 3 was not performed, hence the recommended dose was not determined.

Primary endpoints There was not severe adverse event in Level 0 to Level 2. The level 3 was not performed, hence the recommended dose was not determined. Secondary endpoints Peptide specific immunity was induced in five patients among nine patients. OS and PFS was not calculate yet. CR+PR (objective response rate) rate was 0/9 (0%) and CR+PR+SD (disease control rate was 2/9 (22.2 %).

There was not severe adverse event in Level 0 to Level 2. The level 3 was not performed, hence the recommended dose was not determined. Peptide specific immunity was induced in five patients among nine patients. OS and PFS was not calculate yet. CR+PR (objective response rate) rate was 0/9 (0%) and CR+PR+SD (disease control rate was 2/9 (22.2 %). This vaccination therapy might induce peptide specific immunity, hence pivotal study might be warranted in the future.

Mar. 31, 2022

Yes

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs061180034

Nagano Hiroaki

Yamaguchi University Hospital

1-1-1,MinamiKogushi,Ube City

geka2dm@yamaguchi-u.ac.jp

Hazama Shoichi

Yamaguchi University School of Medicine

1-1-1,MinamiKogushi,Ube City

+81-836-22-2888

hazama@yamaguchi-u.ac.jp

Complete

April. 01, 2016

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1. Colorectal cancer proven by histology or imaging (CT or MRI)
2. Patients with HLA-A*2402
3. Standard treatment failure colorectal cancer
4. Age; 20>=
5. Performance Status (PS); 0-2, Eastern Cooperative
Oncology Group (ECOG)
6. Preserved organ functions (number of WBCs more than
2.0x103/mm3; % of lymphocyte >=15; number of platelets
>=7.5x103/mm3; hemoglobin >=8.0 g/ dl; creatinine <=2.5
times of upper normal limit)
7.Patients provided written, informed consent to participate

The exclusion criteria were, double cancer, pneumonitis, severe allergy, severe infection, neurological disturbance, uncontrolled general diseases, heart diseases, general steroid treatment, or any prior therapies using same agents of this study.

Both

advanced or metastatic colorectal cancer

Combination Immunotherapy with peptide vaccination

safety

specific CTL response
overall survival
progression-free survival
Response rate
disease control rate
Immune-related response criteria

+81-836-22-2428

Jan. 09, 2019

none