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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00086350 | Other Identifier | JHMIRB | |
| FD-R-004819-01 | Other Grant/Funding Number | FDA OOPD |
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This study will enroll patients who have metastatic pancreatic cancer with stable disease on FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive FOLFIRINOX.
Funding Source - FDA Office of Orphan Product Development (OOPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipilimumab + Vaccine (Arm A) | Experimental | Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. |
|
| FOLFIRINOX (Arm B) | Experimental | Administered every 14 days (one cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Drug | 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival is the time between the date of randomization on study and death. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine | Toxicity was assessed as the number of patients experiencing study drug-related adverse events (AEs). Data reported for only study drug-related adverse events (not all adverse events as reported in the adverse events section). | From the first dose of study drug through 70 days after last dose, up to 13 months |
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Inclusion Criteria (abbreviated):
Exclusion Criteria (abbreviated):
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| Name | Affiliation | Role |
|---|---|---|
| Dung Le, M.D. | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipilimumab + Vaccine | Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections |
| FG001 | FOLFIRINOX |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 10, 2017 |
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| Vaccine | Biological | 5x10^8 cells administered in 6 intradermal injections |
|
|
| FOLFIRINOX | Drug | Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle. |
|
| Progression Free Survival (PFS) | Progression Free Survival is the time from date of randomization to progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan. | Up to 4 years |
| Immune-related Progression Free Survival (irPFS) | Immune-related Progression Free Survival is the median time from date of randomization to disease progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan. Disease progression was evaluated using immune-related Response Criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease. | Up to 4 years |
| Objective Response Rate | Objective Response Rate (ORR) is defined as the number of patients from each group achieving a Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria In Solid Tumors (RECIST). | Assessed until disease progression, up to 2 years |
| Immune-related Objective Response Rate | Immune-related Objective Response Rate (irORR) is measured the same way, except that tumor responses are evaluated using immune-related response criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease. | Assessed until disease progression, up to 2 years |
| Duration of Response | Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease. | Up to 22 months |
| Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels | Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0-36 U/mL. | Baseline, Week 7, and Week 10 visits |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipilimumab + Vaccine | Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections |
| BG001 | FOLFIRINOX | Administered every 14 days (one cycle) FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| CA19-9 Secretors | Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0- 36 U/mL. Individuals with elevated CA19-9 were considered secretors. Those who did not express CA19-9 were considered non-secretors. | Count of Participants | Participants |
| |||||||||||||||
| CA19-9 at baseline | Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0- 36 U/mL. | Individuals who did not express CA19-9 were considered non-secretors and were excluded from analysis. | Median | Inter-Quartile Range | IU/mL |
|
| 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 | Overall Survival (OS) | Overall Survival is the time between the date of randomization on study and death. | 1 Arm A (Ipilimumab + Vaccine) patient was lost to follow-up prior to treatment and was excluded from analysis. | Posted | Median | 95% Confidence Interval | Months | 4 years |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine | Toxicity was assessed as the number of patients experiencing study drug-related adverse events (AEs). Data reported for only study drug-related adverse events (not all adverse events as reported in the adverse events section). | AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity. Dose of Ipilimumab was reduced from 10 mg/kg to 3 mg/kg due to toxicity concerns. Toxicity rates are compared between these dosing subgroups. | Posted | Count of Participants | Participants | From the first dose of study drug through 70 days after last dose, up to 13 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Progression Free Survival is the time from date of randomization to progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan. | 1 Arm A patient was lost to follow-up prior to treatment and was excluded from analysis. | Posted | Median | 95% Confidence Interval | Months | Up to 4 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Immune-related Progression Free Survival (irPFS) | Immune-related Progression Free Survival is the median time from date of randomization to disease progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan. Disease progression was evaluated using immune-related Response Criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease. | 1 Arm A patient was lost to follow-up prior to treatment and was excluded from analysis. | Posted | Median | 95% Confidence Interval | Months | Up to 4 years |
| ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Objective Response Rate (ORR) is defined as the number of patients from each group achieving a Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria In Solid Tumors (RECIST). | 6 Arm A patients were excluded from analysis (1 lost to follow-up prior to treatment, 1 off study before first follow-up scan, 4 had no measurable disease at baseline and therefore could not have a radiographic response). 13 Arm B patients were excluded from analysis (7 came off study before first follow-up scan, 6 had no measurable disease) | Posted | Count of Participants | Participants | Assessed until disease progression, up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Immune-related Objective Response Rate | Immune-related Objective Response Rate (irORR) is measured the same way, except that tumor responses are evaluated using immune-related response criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease. | 6 Arm A patients were excluded from analysis (1 lost to follow-up prior to treatment, 1 off study before first follow-up scan, 4 had no measurable disease at baseline and therefore could not have a radiographic response). 13 Arm B patients were excluded from analysis (7 came off study before first follow-up scan, 6 had no measurable disease) | Posted | Count of Participants | Participants | Assessed until disease progression, up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease. | Only 1 patient on Arm A (Ipilimumab + Vaccine) and 3 patients on Arm B (FOLFIRINOX) achieved a response by RECIST and were included in this analysis. 2 additional patients (1 Arm A and 1 Arm B) achieved a response by irRC, but these patients were both taken off study the same day as their partial response, for disease progression by RECIST. | Posted | Mean | Full Range | months | Up to 22 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels | Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0-36 U/mL. | Only patients who were considered CA19-9 secretors (expressed CA19-9 either on study or prior to study) were included in the analysis. 32 in Arm A (Ipilimumab+Vaccine) and 31 in Arm B (FOLFIRINOX). Only subjects evaluable for this outcome at the specified time points had CA19-9 drawn and could be included in the analysis. | Posted | Median | Inter-Quartile Range | IU/mL | Baseline, Week 7, and Week 10 visits |
|
Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
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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 | Ipilimumab + Vaccine | Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10^8 cells administered in 6 intradermal injections | 5 | 39 | 20 | 39 | 39 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| adrenal insufficiency | Endocrine disorders | Non-systematic Assessment |
| ||
| alkaline phosphatase increased | Investigations | Non-systematic Assessment |
| ||
| bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| blood bilirubin increased | Investigations | Non-systematic Assessment |
| ||
| catheter related infection | Infections and infestations | Non-systematic Assessment |
| ||
| chest wall pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| death, disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| delerium | Psychiatric disorders | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| hypophysitis | Endocrine disorders | Non-systematic Assessment |
| ||
| INR increased | Investigations | Non-systematic Assessment |
| ||
| lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| malabsorption | Gastrointestinal disorders | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| neutropenia | Investigations | Non-systematic Assessment |
| ||
| obstruction gastric | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| thromboembolic event - pulmonary embolism | Vascular disorders | Non-systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| weight loss | Investigations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal distention | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| alkaline phosphatase increased | Investigations | Non-systematic Assessment |
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| alanine aminotransferase (ALT) increased | Investigations | Non-systematic Assessment |
| ||
| anemia | Investigations | Non-systematic Assessment |
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| anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| anxiety | Psychiatric disorders | Non-systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| ascites | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| aspartate aminotransferase (AST) increased | Investigations | Non-systematic Assessment |
| ||
| atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| blood bilirubin increased | Investigations | Non-systematic Assessment |
| ||
| bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| chills | General disorders | Non-systematic Assessment |
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| cold intolerance | General disorders | Non-systematic Assessment |
| ||
| colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| difficulty urinating | Renal and urinary disorders | Non-systematic Assessment |
| ||
| dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| edema limbs | General disorders | Non-systematic Assessment |
| ||
| fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| fatigue | General disorders | Non-systematic Assessment |
| ||
| fever | General disorders | Non-systematic Assessment |
| ||
| flatulence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| flu-like symptoms | General disorders | Non-systematic Assessment |
| ||
| gait disturbance | General disorders | Non-systematic Assessment |
| ||
| headache | Nervous system disorders | Non-systematic Assessment |
| ||
| hot flashes | Vascular disorders | Non-systematic Assessment |
| ||
| hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypophysitis | Endocrine disorders | Non-systematic Assessment |
| ||
| hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| lymph node pain | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| lymphocyte count decreased | Investigations | Non-systematic Assessment |
| ||
| muscle cramp | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| non-cardiac pain | General disorders | Non-systematic Assessment |
| ||
| oral pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| pain, site of procedure/conmed | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| rhinitis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| thromboembolic event | Vascular disorders | Non-systematic Assessment |
| ||
| upper respiratory infection | Infections and infestations | Non-systematic Assessment |
| ||
| urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| weight loss | Investigations | Non-systematic Assessment |
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| vaccine site blisters | General disorders | Non-systematic Assessment |
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| vaccine site bruising | General disorders | Non-systematic Assessment |
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| vaccine site erythema | General disorders | Non-systematic Assessment |
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| vaccine site flares | General disorders | Non-systematic Assessment |
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| vaccine site induration | General disorders | Non-systematic Assessment |
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| vaccine site pruritus | General disorders | Non-systematic Assessment |
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| vaccine site tenderness | General disorders | Non-systematic Assessment |
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The Principal Investigators (PIs) from participating sites must provide the Johns Hopkins PI with a copy of any proposed publication for review and comment at least 30 days prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dung Le | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 443-287-0002 | dle2@jhmi.edu |
| Apr 22, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D014612 | Vaccines |
| C000627770 | folfirinox |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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