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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00137389 | Other Identifier | Johns Hopkins University | |
| 5P01CA247886-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Aduro Biotech, Inc. | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207 | Experimental |
| |
| Arm B: Nivolumab, Ipilimumab, CRS-207 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) | Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs) | When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded. | 21 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dung Le, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins SKCCC | Baltimore | Maryland | 21231 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207 | Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2. Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| 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 | Dec 10, 2020 |
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|
| Nivolumab | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6. |
|
|
| Ipilimumab | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5. |
|
|
| GVAX Pancreas Vaccine | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2. |
|
|
| CRS-207 | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6. |
|
| CRS-207 | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6. |
|
| FG001 | Arm B: Nivolumab, Ipilimumab, CRS-207 | Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207 | Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2. Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| BG001 | Arm B: Nivolumab, Ipilimumab, CRS-207 | Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6. |
| 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 |
|
| 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 | Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) | Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis. | Only 29/30 participants in Arm A were evaluable for this endpoint. One participant was not evaluable after they discontinued prior to their first scan for a reason other than toxicity or progression. | Posted | Count of Participants | Participants | 18 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs) | When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded. | Posted | Count of Participants | Participants | 21 months |
|
Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) 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 | Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207 | Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2. Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6. | 28 | 30 | 24 | 30 | 30 | 30 |
| EG001 | Arm B: Nivolumab, Ipilimumab, CRS-207 | Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6. | 27 | 27 | 21 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Disease progression | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Embolic or Cardiovascular Event | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Gastroesophageal sticture | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| GI tube site bleeding | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Cerebral hemorrhage | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Immune Thrombocytopenia Purpura | Blood and lymphatic system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE version 4.03 | Systematic Assessment |
| |
| Listeria monocytogenes bacteremia | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Lower GI Hemorrhage | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Radiculitis | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4.03 | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Biliary stricture | Hepatobiliary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE version 4.03 | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE version 4.03 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Gait disturbance | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE version 4.03 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE version 4.03 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Mucositis oral | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vaccine site adminstration discomfort | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vaccine site erythema | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vaccine site induration | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vaccine site pain | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vaccine site pruritis | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE version 4.03 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE version 4.03 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dung Le, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 443-287-0002 | dle@jhmi.edu |
| May 22, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| 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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|