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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00130075 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CY, Nivolumab, GVAX, and SBRT | Experimental | CY, Nivolumab, GVAX, and SBRT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given. |
| Measure | Description | Time Frame |
|---|---|---|
| CD8+ T Cell Density in Tumor Tissue | Mean CD8+ T cell density [log(cells per mm^2)], found in resected surgical tissue by Immunohistochemistry (IHC). | evaluated at time of surgery, approximately 2 months from first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) Rate at Surgical Resection | Number of patients with a pathologic complete response (pCR) rate at surgical resection. A pCR is defined as no viable residual tumor remaining at the time of evaluation. | Assessed at time of surgical resection, approximately 2 months after first dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Laheru, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Arsen Osipov, MD | 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 | United States | ||
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Participants with borderline resectable pancreatic cancer were enrolled on the study prior to starting standard of care chemotherapy. After completing chemotherapy, participants were re-screened to determine if they were eligible to continue on the study and receive study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | CY, Nivolumab, GVAX, and SBRT | Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected. Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle. Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle. GVAX Pancreas Vaccine: 5x10^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle. Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days |
| 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 | Aug 2, 2023 |
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Open Label
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| Nivolumab | Drug | Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given. |
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| GVAX Pancreas Vaccine | Drug | Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given. |
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| Stereotactic Body Radiation (SBRT) | Radiation | SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy). |
|
| Medical College of Wisconsin |
| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
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| COMPLETED | Completed = received at least one dose of study drug |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CY, Nivolumab, GVAX, and SBRT | Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected. Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle. Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle. GVAX Pancreas Vaccine: 5x10^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle. Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days |
| 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 | Median | Full Range | years |
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| 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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| Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG scale measures performance status, with scores ranging from 0-5; 0= fully active, performs without restriction, 1= can ambulate, but restricted in physically strenuous activity, 2= ambulatory and capable of self-care, but unable to work, active for >50% of waking hours, 3= limited self-care, confined to bed or chair for >50% of waking hours, 4= completely disabled, totally confined to bed/chair, 5= deceased | 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 | CD8+ T Cell Density in Tumor Tissue | Mean CD8+ T cell density [log(cells per mm^2)], found in resected surgical tissue by Immunohistochemistry (IHC). | Only participants who received study drug, completed surgical resection, and had sufficient tissue to perform IHC analysis. Of the 18 participants treated on study, 13 had sufficient tissue to perform CD8 analysis. | Posted | Mean | Standard Deviation | log (cells per mm^2) | evaluated at time of surgery, approximately 2 months from first dose of study drug |
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| Secondary | Pathologic Complete Response (pCR) Rate at Surgical Resection | Number of patients with a pathologic complete response (pCR) rate at surgical resection. A pCR is defined as no viable residual tumor remaining at the time of evaluation. | Only participants who received study drug and completed surgical resection are included. Of the 18 participants treated on study, 14 completed surgical resection. | Posted | Count of Participants | Participants | Assessed at time of surgical resection, approximately 2 months after first dose of study drug |
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Up to 20 weeks
Adverse events and All Cause Mortality were collected for any patient that received at least one dose of study drug. Of the 31 patients that enrolled, 18 received study drug and were evaluable for adverse events.
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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 | CY, Nivolumab, GVAX, and SBRT | Participants received a total of two cycles of Cylophosphamide (CY), Nivolumab, and GVAX Pancreas Vaccine, starting 4-6 weeks after completion of standard of care chemotherapy. Stereotactic Body Radiation Therapy (SBRT) was given over 5 days concurrently with the start of the second cycle. Patients were then evaluated for surgery, and if eligible, had their pancreas tumors resected. Cyclophosphamide: 200 mg/m2 IV over 30 minutes on Day 1 of each 21-day cycle. Nivolumab: 240 mg IV over 60 minutes on Day 1 of each 21-day cycle. GVAX Pancreas Vaccine: 5x10^8 cells, given as 6 intradermal injections (2 on each thigh and 2 on the non-dominant arm), given on Day 2 of each cycle. Stereotactic Body Radiation (SBRT): 6.6 Gy over 5 days | 0 | 18 | 3 | 18 | 16 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bile duct stenosis | Hepatobiliary disorders | Systematic Assessment |
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| sepsis | Infections and infestations | Systematic Assessment |
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| skin infection | Infections and infestations | Systematic Assessment |
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| weight loss | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| hyperthyroidism | Endocrine disorders | Systematic Assessment |
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| hypothyroidism | Endocrine disorders | Systematic Assessment |
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| blurred vision | Eye disorders | Systematic Assessment |
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| dry eye | Eye disorders | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| bloating | Gastrointestinal disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| flatulence | Gastrointestinal disorders | Systematic Assessment |
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| blood in stool | Gastrointestinal disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| upper gastrointestinal hemorrage | Gastrointestinal disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| chills | General disorders | Systematic Assessment |
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| edema limbs | General disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
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| flu-like symptoms | General disorders | Systematic Assessment |
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| infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| pain at site of biopsy | Injury, poisoning and procedural complications | Systematic Assessment |
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| alanine aminotransferase increased | Investigations | Systematic Assessment |
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| alkaline phosphatase increased | Investigations | Systematic Assessment |
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| aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| creatinine increased | Investigations | Systematic Assessment |
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| hypokalemia | Investigations | Systematic Assessment |
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| neutrophil count decreased | Investigations | Systematic Assessment |
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| platelet count decreased | Investigations | Systematic Assessment |
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| weight loss | Investigations | Systematic Assessment |
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| white blood cell decreased | Investigations | Systematic Assessment |
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| anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| joint stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| dizziness | Nervous system disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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| peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
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| confusion | Psychiatric disorders | Systematic Assessment |
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| breast pain | Reproductive system and breast disorders | Systematic Assessment |
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| voice alteration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| rash maculopapular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| hot flashes | Vascular 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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| vaccine site discoloration | General disorders | Systematic Assessment |
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| erythema at vaccine site | General disorders | Systematic Assessment |
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| induration at vaccine site | General disorders | Systematic Assessment |
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| peeling skin at vaccine site | General disorders | Systematic Assessment |
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| pruritus at vaccine site | General disorders | Systematic Assessment |
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| swelling at vaccine sites | General disorders | Systematic Assessment |
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| tenderness at vaccine site | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Laheru, MD | Sidney Kimmel Cancer Center at Johns Hopkins | 410-955-8974 | laherda@jhmi.edu |
| Dec 27, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| 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 |
|---|---|
| D003520 | Cyclophosphamide |
| D000077594 | Nivolumab |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| 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 |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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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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