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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00118520 | Other Identifier | JHMIRB | |
| 5P01CA247886-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
| Incyte Corporation | INDUSTRY |
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This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy.
Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207.
The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Level 1 | Experimental | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 |
|
| Part 1: Dose Level 2 | Experimental | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 |
|
| Part 1X: Dose Level 2 | Experimental | Epacadostat/Pembrolizumab/CRS-207 |
|
| Part 1X: Dose Level 3 | Experimental | Epacadostat/Pembrolizumab/CRS-207 |
|
| Part 2: Dose Expansion | Experimental | Epacadostat/Pembrolizumab/CRS-207 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epacadostat | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100, 300, or 600 mg) is taken by mouth twice a day, every day. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Epacadostat | Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day. | 9 weeks |
| 6 Month Survival | Number of subjects who are alive 6 months or longer after the date of first treatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation | 15 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 |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
One participant was excluded from analysis because they did not receive the study drug due to their inability to maintain eligibility after enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Dose Level 1 | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 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 | Apr 20, 2021 |
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|
| Pembrolizumab | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. |
|
|
| CRS-207 | Biological | CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
|
| Cyclophosphamide | Drug | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2. |
|
|
| GVAX Pancreas Vaccine | Biological | Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. |
|
|
| FG001 | Part 1: Dose Level 2 | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| FG002 | Part 1X: Dose Level 2 | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| FG003 | Part 1X: Dose Level 3 | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| FG004 | Part 2: Dose Expansion | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
|
| COMPLETED | Completed = Received 1 course (6 cycles) of treatment |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Dose Level 1 | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| BG001 | Part 1: Dose Level 2 | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| BG002 | Part 1X: Dose Level 2 | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| BG003 | Part 1X: Dose Level 3 | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| BG004 | Part 2: Dose Expansion | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| BG005 | 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 | Maximum Tolerated Dose (MTD) of Epacadostat | Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day. | In Part 1 of the study (Epacadostat dose escalation), six patients were assessed in Dose Level 1 (DL1), seven patients were assessed in Dose Level 2 (DL2), and six patients were assessed in Dose Level 3 (DL3) since one patient was replaced because they came off treatment prior to completing the dose limiting toxicity (DLT) review period. | Posted | Number | mg BID | 9 weeks |
|
|
| ||||||||||||||||||||||||||
| Primary | 6 Month Survival | Number of subjects who are alive 6 months or longer after the date of first treatment. | Per the clinical trial design, 6 month survival analyses included all subjects who received the MTD (Dose Level 3). Since the enrollment criteria and dose are the same, combining those who are treated at MTD at both parts increase the power and enable to estimate the treatment effect with increased precision. This included the 6 subjects evaluable in Part 1X portion of the trial and the 20 subjects enrolled in Part 2 portion of the trial for a total of 26 subjects. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation | Posted | Count of Participants | Participants | 15 months |
|
Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of 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 | Part 1: Dose Level 1 | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. | 5 | 6 | 3 | 6 | 6 | 6 |
| EG001 | Part 1: Dose Level 2 | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. | 4 | 4 | 3 | 4 | 4 | 4 |
| EG002 | Part 1X: Dose Level 2 | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. | 3 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Part 1X: Dose Level 3 | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. | 7 | 7 | 2 | 7 | 7 | 7 |
| EG004 | Part 2: Dose Expansion | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. | 19 | 20 | 7 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Gastroparesis | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Disease progression | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Visceral arterial ischemia | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE version 5 | Systematic Assessment |
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| Volume overload | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
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| IVC stenosis | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
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| Jejunal stenosis | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hepatic infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
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| Immune Thrombocytopenic Purpura | Blood and lymphatic system disorders | CTCAE version 4.03 | Systematic Assessment |
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| Transaminitis | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Fever | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Billiary track infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4.03 | Systematic Assessment |
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| Stroke | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE version 4.03 | Systematic Assessment |
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| Enlarged lymp nodes | Blood and lymphatic system disorders | CTCAE version 4.03 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
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| Palpitations | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
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| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
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| Pseudoaneurysm | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | CTCAE version 4.03 | Systematic Assessment |
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| Ear bleading | Ear and labyrinth disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | CTCAE version 4.03 | Systematic Assessment |
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| Dry eye | Eye disorders | CTCAE version 4.03 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Belching | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Polydipsia | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Pancreatic duct stricture | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Chills | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Edema face | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Edema limbs | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Fever | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Flu like symptoms | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Infusion related reaction | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Pain at biopsy site | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Groin pain | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Influenza viral infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
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| COVID-19-infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
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| Thrush | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | CTCAE version 4.03 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE version 4.03 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Lipase increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Serum amylase increased | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Weight gain | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE version 4.03 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
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| Glucose intolerance | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pain in extremity | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Cold intolerance-hands and feet | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Depression | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Uterine obstruction | Reproductive system and breast disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Rash pustular | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
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| Flushing | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Subungual hematoma | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
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| Phlebitis | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| MRSA infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
| |
| Abdominal mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4.03 | Systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE version 4.03 | Systematic Assessment |
| |
| Skin peeling | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
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| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vaccine site erythema | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Vaccine site hyperpigmentation | 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 |
| |
| IVC stenosis | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
| |
| Skin laceration | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dung Le, MD | SKCCC Johns Hopkins Medical Institution | 443-287-0002 | Dle@jhmi.edu |
| May 20, 2024 |
| Prot_SAP_000.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613752 | epacadostat |
| C582435 | pembrolizumab |
| D003520 | Cyclophosphamide |
| 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 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=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 |
|
|
| OG002 | Part 1X: Dose Level 2 | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| OG003 | Part 1X: Dose Level 3 | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
| OG004 | Part 2: Dose Expansion | Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. |
|
|