Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Malignant Tumor
|ClinicalTrials.gov Identifier: NCT03662815|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : September 4, 2019
This research study is evaluating a new type of cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced malignant tumor. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients with advanced malignant cancer, so as to provide a new personalized therapeutic strategy for advanced pancreatic cancer patients.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Tumor||Biological: iNeo-Vac-P01 Other: GM-CSF||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Tolerability and Partial Efficacy Study of a Personalized Neoantigen Cancer Vaccine inTreating Patients With Advanced Malignant Tumor|
|Actual Study Start Date :||February 7, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Personal Cancer Vaccine: iNeo-Vac-P01 (peptides)+ GM-CSF;
Peptides: 0.1 or 0.3 mg per peptide given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses. Additional booster vaccines might be administered depending on ethics and patients' potential benefit.
GM-CSF: 40 mcg given 30 minutes before iNeo-Vac-P01.
Other Name: granulocyte-macrophage colony stimulating factor
- Objective Response Rate [ Time Frame: 2 years ]
- Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: 1 year ]
- Overall Survival Rate [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- Measurement of CD4/CD8 T lymphocyte subsets [ Time Frame: 2 years ]
- The polypeptide antigen - induced IFN-γ T cells responses [ Time Frame: 2 years ]
- Peripheral blood T cell receptor sequencing analysis [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662815
|Sir Run Run Shaw Hospital|
|Hangzhou, Zhejiang, China, 310000|