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Antineoplastic Agents, Immunological

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personalized vaccine and anti-PD-1 administered concurrently at the start of study therapy

anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy

anti-PD-1 antibody followed by personalized vaccine therapy

Vaccine will be constructed for each subject that express multiple candidate tumor-derived neoantigens.

personalized vaccine

200 mg pembrolizumab will be administered intravenous (IV) infusion every 3 weeks.

Erza Cohen, MD

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.

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.

Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers

A Phase 1b Safety and Feasibility Study of Personalized Immunotherapy in Adults With Advanced Cancers

Duration of time from start of study treatment until objective tumor progression or death.

Duration of time from start of study treatment until objective tumor progression.

Duration of time from start of study treatment to death

Ezra Cohen

Professor of Medicine

Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Nivolumab

3mg/kg nivolumab will be administered intravenous (IV) infusion every 3 weeks for 4 doses. After 4 doses, 480 mg nivolumab will be administered intravenous (IV) infusion every 4 weeks.

Shakeela Dad

Aaron Miller

Ezra Cohen, MD

The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.

The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.

It is known that cancer has mutations (changes in genetic material) that are specific to an individual person and their tumor. These mutations can cause the tumor cells to produce proteins that are different from the body's normal, healthy cells. The study will use a sample of your tumor to create a vaccine against it, with the idea being that the study vaccine will "teach" the body's immune system to recognize and attack the cancer cells. The study will examine the safety of the study vaccine when given at several time points and will examine your blood for signs that the study vaccine causes the immune system to respond.

The personalized cancer vaccine will be given alone or in combination with nivolumab. Nivolumab is a drug that blocks certain proteins on cells that help to keep immune responses in check. In a healthy person, this keeps the immune system from attacking healthy cells and tissues, but cancer cells use these proteins to keep the immune system from killing cancer cells and tumors. When these proteins are blocked, the check on the immune system is removed and immune cells may be able to recognize and kill cancer cells.

This personalized cancer vaccine is considered experimental because it is not approved by the US Food \& Drug Administration (FDA) as a treatment for cancer.

The combination of nivolumab and the personalized cancer vaccine is experimental and is not FDA approved.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers	NCT03568058	Advanced Cancer	personalized va... Pembrolizumab	18 Years -	University of California, San Diego
Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers	NCT05153304	Cancer of Gastr...	personalized va... Nivolumab	18 Years -	University of California, San Diego
Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers	NCT05153304	Cancer of Gastr...	personalized va... Nivolumab	18 Years -	University of California, San Diego
Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers	NCT03568058	Advanced Cancer	personalized va... Pembrolizumab	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for personalized cancer vaccine