Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers
- Conditions
- Advanced Cancer
- Interventions
- Drug: personalized vaccine
- Registration Number
- NCT03568058
- Lead Sponsor
- Ezra Cohen
- Brief Summary
The purpose of this study is to determine if it is possible to make and administer safely a 'personalized' vaccine to treat patients that have been diagnosed with advanced cancer and are not candidates for curative therapy.
- Detailed Description
The purpose of this study is to determine if it is possible to make and administer safely a 'personalized' vaccine to treat patients that have been diagnosed with advanced cancer and are not candidates for curative therapy.
This 'personalized' vaccine will use information gained from specific characteristics of your own cancer. It is known that cancer has mutations (changes in genetic material) that are specific to an individual 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 (protective) responses, which may help your body fight any tumor cells that could cause your cancer to come back in the future. The study will examine the safety of the vaccine when given at several time points and will examine your blood cells for signs that the vaccine induced an immune response.
The personalized vaccine will be given in combination with an anti-PD1 antibody, pembrolizumab, which is used with the intention to increase anti-cancer immunity (protection). Pembrolizumab is a type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. These proteins help keep immune responses in check and can keep T cells from killing cancer cells. When these proteins are blocked, the "brakes" on the immune system are released and T cells are able to kill cancer cells better.
This personalized vaccine is considered experimental because this is not an FDA approved therapy for cancer.
Pembrolizumab is FDA approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma (cHL), primary mediastinal large b-cell lymphoma (PMBCL), urothelial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma (cSCC), triple-negative breast cancer (TNBC), microsatellite instability-high (MSI-H) or mismatch repair deficient cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC), gastric cancer, esophageal cancer, cervical cancer, and hepatocellular carcinoma (HCC), merkel cell carcinoma (MCC), renal cell carcinoma (RCC), endometrial carcinoma. Pembrolizumab is considered experimental (investigational) for the treatment of all other cancer types.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description anti-PD1 and vaccine personalized vaccine anti-PD-1 antibody followed by personalized vaccine therapy vaccine and anti-PD-1 personalized vaccine personalized vaccine and anti-PD-1 administered concurrently at the start of study therapy anti-PD1 before vaccine personalized vaccine anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy vaccine personalized vaccine personalized vaccine therapy vaccine and anti-PD-1 Pembrolizumab personalized vaccine and anti-PD-1 administered concurrently at the start of study therapy anti-PD1 before vaccine Pembrolizumab anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy anti-PD1 and vaccine Pembrolizumab anti-PD-1 antibody followed by personalized vaccine therapy
- Primary Outcome Measures
Name Time Method Quantitative frequency of TCR 1 year Quantitative frequency of TCR
Number of Participants with Treatment-related Adverse Events 1 year Number of Participants with Treatment-related Adverse Events
- Secondary Outcome Measures
Name Time Method Overall Survival 1 year Duration of time from start of study treatment to death
Overall Response 1 year RECIST 1.1
Progression-free survival (PFS) 1 year Duration of time from start of study treatment until objective tumor progression or death.
Time to Progression 1 year Duration of time from start of study treatment until objective tumor progression.
Trial Locations
- Locations (1)
UCSD Medical Center
🇺🇸San Diego, California, United States