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| ID | Type | Description | Link |
|---|---|---|---|
| BMS # CA184-081 |
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Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells) administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
Primary Objective: To determine the safety profile of ipilimumab alone or in combination with a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Ipilimumab Alone | Experimental | Ipilimumab alone |
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| Arm 2: Ipilimumab + Pancreatic Cancer Vaccine | Experimental | Ipilimumab + Pancreatic Cancer Vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Experiencing an Unacceptable Toxicity | Unacceptable toxicity is defined as drug related >grade 4 AEs or grade 3 AEs including IRAEs not improving to < grade 2 under therapy within 2 weeks. In addition, > grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to < grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS will be measured from date of randomization until death or end of follow-up (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). | 4 years |
| Overall Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dung Le, MD | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23924790 | Result | Le DT, Lutz E, Uram JN, Sugar EA, Onners B, Solt S, Zheng L, Diaz LA Jr, Donehower RC, Jaffee EM, Laheru DA. Evaluation of ipilimumab in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in previously treated pancreatic cancer. J Immunother. 2013 Sep;36(7):382-9. doi: 10.1097/CJI.0b013e31829fb7a2. | |
| 29997287 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Ipilimumab Alone | Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks. |
| FG001 | Arm 2: Ipilimumab + Pancreatic Cancer Vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pancreatic Cancer Vaccine | Biological | The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks. |
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ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) during the first 6 months of treatment. CR = disappearance of all target lesions, 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. Estimation based on the Kaplan-Meier curve. |
| 6 months |
| Immune Related Best Overall Response Rate (irBOR) | Immune Related Best Overall Response (BOR) is the best response recorded from the start of the study treatment until the disease progression/recurrence based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Estimation based on the Kaplan-Meier curve. | 4 years |
| Progression Free Survival (PFS) | 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. | 6 months |
| 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. |
Drug: Ipilimumab Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.
Biological/Vaccine: Pancreatic Cancer Vaccine The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Ipilimumab Alone | Ipilimumab alone |
| BG001 | Arm 2: Ipilimumab + Pancreatic Cancer Vaccine | Ipilimumab + Pancreatic Cancer Vaccine |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Percent of Patients Experiencing an Unacceptable Toxicity | Unacceptable toxicity is defined as drug related >grade 4 AEs or grade 3 AEs including IRAEs not improving to < grade 2 under therapy within 2 weeks. In addition, > grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to < grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity. | Posted | Number | Percentage of Participants | 4 years |
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| Secondary | Overall Survival (OS) | OS will be measured from date of randomization until death or end of follow-up (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 | 4 years |
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| Secondary | Overall Response Rate (ORR) | ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) during the first 6 months of treatment. CR = disappearance of all target lesions, 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. Estimation based on the Kaplan-Meier curve. | Not Posted | 6 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Immune Related Best Overall Response Rate (irBOR) | Immune Related Best Overall Response (BOR) is the best response recorded from the start of the study treatment until the disease progression/recurrence based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Estimation based on the Kaplan-Meier curve. | Not Posted | 4 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | 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. | Not Posted | 6 months | Participants |
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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 1: Ipilimumab Alone | Ipilimumab alone | 3 | 15 | 11 | 15 | ||
| EG001 | Arm 2: Ipilimumab + Pancreatic Cancer Vaccine | Ipilimumab + Pancreatic Cancer Vaccine | 1 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephritis | Renal and urinary disorders |
| |||
| Colitis | Gastrointestinal disorders |
| |||
| Guillain-Barre Syndrome | Nervous system disorders |
| |||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders |
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| Hypophysitis | Endocrine disorders |
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| Conjuntivitis | Eye disorders |
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| Colitis | Gastrointestinal disorders |
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| Arthralgia | Musculoskeletal and connective tissue disorders |
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| Anorexia | Gastrointestinal disorders |
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| Cramps | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Dry eye | Eye disorders |
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| Dry skin | Skin and subcutaneous tissue disorders |
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| Fatigue | General disorders |
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| Fever | General disorders |
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| Flu-like symptoms | General disorders |
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| Headache | Nervous system disorders |
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| Nausea | Gastrointestinal disorders |
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| Pruritis | Skin and subcutaneous tissue disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Urticaria | Skin and subcutaneous tissue disorders |
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| Blister, vaccine site | Skin and subcutaneous tissue disorders |
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| Hyperpigmentation, vaccine site | Skin and subcutaneous tissue disorders |
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| Pruritis, vaccine site | Skin and subcutaneous tissue disorders |
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| Erythema, vaccine site | Skin and subcutaneous tissue disorders |
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| Induration, vaccine site | Skin and subcutaneous tissue disorders |
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| Tenderness, vaccine site | Skin and subcutaneous tissue disorders |
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| Urticaria, vaccine site | Skin and subcutaneous tissue disorders |
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| Vaccine Site Flare | Skin and subcutaneous tissue disorders |
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| Warmth, vaccine site | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dung Le | The Sidney Kimmel Comprehensive Cancer Center at Johns | dle@jhmi.edu |
| 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 |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| 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 |
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| >=65 years |
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| Male |
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