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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. | Experimental | Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. |
|
| Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. | Experimental | Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. |
|
| Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule | Experimental | Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Vaccine | Drug | Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Adverse Events | Number of Treatment-related Adverse Events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response | RECIST 1.1 - Overall Response | 1 year |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Miller, MD, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy. | Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| FG001 | Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy. | Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| FG002 | Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule | Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| FG003 | Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy. | Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No patients were enrolled in Arm B
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy. | Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment-related Adverse Events | Number of Treatment-related Adverse Events | No participants were enrolled in Arm B | Posted | Number | Number of Treatment-related Adverse Even | 1 year |
|
4 years, 11 months
No participants enrolled in Arm B
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy. | Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tracheal obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron Miller | University of California, San Diego | (858) 822-5354 | CancerCTO@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2022 | Jan 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C000711728 | spartalizumab |
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|
| Arm D: Personalized vaccine alone, in a boosted schedule at the start of study therapy. | Experimental | Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. |
|
| Pembrolizumab | Drug | Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
|
|
| BG001 | Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy. | Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| BG002 | Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule | Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| BG003 | Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy. | Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Primary Cancer Site | Count of Participants | Participants |
|
| OG001 | Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy. | Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| OG002 | Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule | Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. |
| OG003 | Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy. | Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. |
|
|
| Secondary | Overall Response | RECIST 1.1 - Overall Response | No participants enrolled in Arm B | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 5 |
| 5 |
| 2 |
| 5 |
| 5 |
| 5 |
| EG001 | Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy. | Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule | Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. | 9 | 13 | 3 | 13 | 13 | 13 |
| EG003 | Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy. | Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. | 1 | 7 | 0 | 7 | 7 | 7 |
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Disease progression | General disorders | Systematic Assessment |
|
| Cardiac Disorders | Cardiac disorders | Systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | Systematic Assessment |
|
| Endocrine disorders | Endocrine disorders | Systematic Assessment |
|
| Eye disorders | Eye disorders | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General disorders and administration | General disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | Systematic Assessment |
|
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