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| ID | Type | Description | Link |
|---|---|---|---|
| ADU-CL-06 | |||
| IRB00043936 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Stand Up To Cancer | OTHER |
| Aduro Biotech, Inc. | INDUSTRY |
| American Association for Cancer Research |
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The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: CY/ GVAX/ CRS-207/ nivolumab | Experimental |
| |
| Arm B: CY/ GVAX/ CRS-207 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRS-207 | Biological | 1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). | 2 years and 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity | When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. | 2 years and 7 months |
| Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dung Le, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29997287 | Derived | Hopkins AC, Yarchoan M, Durham JN, Yusko EC, Rytlewski JA, Robins HS, Laheru DA, Le DT, Lutz ER, Jaffee EM. T cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. JCI Insight. 2018 Jul 12;3(13):e122092. doi: 10.1172/jci.insight.122092. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CY/ GVAX/ CRS-207/ Nivolumab | CRS-207: 1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6 GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6 CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 |
| FG001 |
| 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 | Nov 15, 2016 |
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| OTHER |
| Lustgarten Foundation | OTHER |
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| CRS-207 | Biological | 1 × 10^9 CFU administered IV on Day 1 of Cycles 3-6 |
|
| nivolumab | Drug | 3 mg/kg administered IV on Day 1 of Cycles 1-6 |
|
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| GVAX | Biological | 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 |
|
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| CY | Drug | 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 |
|
|
PFS is defined as the number of months from the date of randomization to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. |
| 2 years and 7 months |
| Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients | irPFS is defined as the number of months from the date of randomization to disease progression (PD or relapse from CR as assessed using irRC RECIST 1.1 criteria) or death due to any cause. Per irRC criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in tumor burden compared with baseline, Progressive Disease (PD) is >20% increase in tumor burden compared with nadir, Stable Disease (SD) is <30% decrease in tumor burden compared with baseline or <20% increase in tumor burden compared to nadir. | 2 years and 7 months |
| Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients | Time to progression (TTP) is defined as the time from randomization to the date of documented disease progression as defined by RECIST 1.1 criteria. Individuals are censored at the date of the last radiological assessment that occurs prior to any of the following: death, switch to another anti-cancer therapy, or end of follow-up. Individuals without follow-up or baseline measurements are censored at 1 day. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | 2 years and 7 months |
| Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients | Per RECIST 1.1 criteria, PR is defined as =>30% decrease in sum of diameters of target lesions and CR is the disappearance of all target lesions. | 2 years and 7 months |
| Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration | Number of participants with stable or responding (<50% increase of serum CA19-9 concentration) at 120 days. | 120 days |
| Stanford |
| California |
| 94305 |
| United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| CY/ GVAX/ CRS-207 |
CRS-207: 1 × 10^9 CFU administered IV Day 1 of Cycles 3-6 GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CY/ GVAX/ CRS-207/ Nivolumab | CRS-207: 1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6 GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6 CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 |
| BG001 | CY/ GVAX/ CRS-207 | CRS-207: 1 × 10^9 CFU administered IV Day 1 of Cycles 3-6 GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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) | OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). | Posted | Median | 95% Confidence Interval | months | 2 years and 7 months |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity | When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. | Posted | Count of Participants | Participants | 2 years and 7 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients | PFS is defined as the number of months from the date of randomization to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | Posted | Median | 95% Confidence Interval | months | 2 years and 7 months |
| |||||||||||||||||||||||||||||||
| Secondary | Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients | irPFS is defined as the number of months from the date of randomization to disease progression (PD or relapse from CR as assessed using irRC RECIST 1.1 criteria) or death due to any cause. Per irRC criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in tumor burden compared with baseline, Progressive Disease (PD) is >20% increase in tumor burden compared with nadir, Stable Disease (SD) is <30% decrease in tumor burden compared with baseline or <20% increase in tumor burden compared to nadir. | Posted | Mean | 95% Confidence Interval | months | 2 years and 7 months |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients | Time to progression (TTP) is defined as the time from randomization to the date of documented disease progression as defined by RECIST 1.1 criteria. Individuals are censored at the date of the last radiological assessment that occurs prior to any of the following: death, switch to another anti-cancer therapy, or end of follow-up. Individuals without follow-up or baseline measurements are censored at 1 day. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | Posted | Median | 95% Confidence Interval | months | 2 years and 7 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients | Per RECIST 1.1 criteria, PR is defined as =>30% decrease in sum of diameters of target lesions and CR is the disappearance of all target lesions. | Posted | Count of Participants | Participants | 2 years and 7 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration | Number of participants with stable or responding (<50% increase of serum CA19-9 concentration) at 120 days. | Posted | Count of Participants | Participants | 120 days |
|
|
2 years and 7 months
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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: CY/ GVAX/ CRS-207/ Nivolumab | CRS-207: 1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6 GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6 CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 | 45 | 51 | 5 | 51 | 46 | 51 |
| EG001 | Arm B: CY/ GVAX/ CRS-207 | CRS-207: 1 × 10^9 CFU administered IV on Day 1 of Cycles 3-6 GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2 | 36 | 42 | 1 | 42 | 40 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
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| MYOCARDITIS | Cardiac disorders | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | Systematic Assessment |
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| LISTERIA SEPSIS | Infections and infestations | Systematic Assessment |
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| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VACCINATION SITE ERYTHEMA | General disorders | Systematic Assessment |
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| VACCINATION SITE INDURATION | General disorders | Systematic Assessment |
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| CHILLS | General disorders | Systematic Assessment |
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| VACCINATION SITE PRURITUS | General disorders | Systematic Assessment |
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| PYREXIA | General disorders | Systematic Assessment |
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| VACCINATION SITE PAIN | General disorders | Systematic Assessment |
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| VACCINATION SITE DISCOMFORT | General disorders | Systematic Assessment |
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| FATIGUE | General disorders | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | Systematic Assessment |
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| VACCINATION SITE OEDEMA | General disorders | Systematic Assessment |
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| VACCINATION SITE SWELLING | General disorders | Systematic Assessment |
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| VACCINATION SITE VESICLES | General disorders | Systematic Assessment |
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| VACCINATION SITE REACTION | General disorders | Systematic Assessment |
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| VACCINATION SITE BRUISING | General disorders | Systematic Assessment |
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| PAIN | General disorders | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | Systematic Assessment |
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| SINUS TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| HEADACHE | Nervous system disorders | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | Systematic Assessment |
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| LYMPHOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dung Le, MD | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 443-287-0002 | dle@jhmi.edu |
| Sep 16, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D003520 | Cyclophosphamide |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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