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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00190660 | Other Identifier | JHMI IRB |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist | Experimental |
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| Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist | Experimental |
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| Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation (SBRT) | Radiation | SBRT (6.6 Gy over 5 days) will be administered between 2 to 4 weeks after chemotherapy. (Prior to surgery) |
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| Measure | Description | Time Frame |
|---|---|---|
| Study Drug-related Adverse Events | Number of participants who experienced study drug-related toxicities as defined by CTCAE v5.0 | Up to 18 months |
| Tumor Immune Response (CD8+ CD137+ Tumor Infiltration) | Number of participants who had >80% increase of infiltration of CD8+CD137+ T cells into their tumors after treatment with SBRT and immunotherapy. Baseline biopsies were collected at time of fiducial placement for SBRT (after completion of chemotherapy) and post-treatment tumor was collected at time of surgical resection | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Number of months from start of immunotherapy until death from any cause | 3 years |
| Metastasis Free Survival (MFS) | Number of months from the start of immunotherapy until first documented distant metastases on radiographic imaging or death from any cause, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amol Narang, MD | Johns Hopkins Medical Institution | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | United States |
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Participants with locally advanced pancreatic cancer (LAPC) were enrolled on the study prior to standard of care chemotherapy and Stereotactic Body Radiation Therapy (SBRT). After completing chemotherapy and SBRT, 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 | Phase I - Dose Level 1 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| 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 20, 2024 |
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| Nivolumab | Drug | Nivolumab (480 mg) will be administered IV over 30 minutes, on day 1 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery Nivolumab will be given on Day 1 of cycles 2-5. Cycles are 4 weeks long. |
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| CCR2/CCR5 dual antagonist | Drug | CCR2/CCR5 dual antagonist (150 mg capsules) will be administered orally twice a day, on days 1-28 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery CCR2/CCR5 dual antagonist will be given daily on cycles 2-5. Cycles are 4 weeks long. |
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| GVAX | Drug | Vaccine (5x10^8 cells) will be administered on day 2 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery GVAX will be given on Day 2 of cycles 2-5. Cycles are 4 weeks long. Six intradermal injections every 4 weeks. |
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| 3 years |
| Local Progression Free Survival (LPFS) | Number of months from the start of immunotherapy until first documented local progression on radiographic imaging or death from any cause, whichever occurs first. Local progression is defined as appearance of new lesions in the pancreas or surgical resection bed (for surgically resected patients) or clinically meaningful tumor growth in the primary pancreas tumor (for patients that were not surgically resectable). | 3 years |
| Surgical Resectability Rate | Number of participants who are able to undergo successful tumor resection (as defined by R0 and R1 resection). | 7 months |
| Pathological Response Rate | Number of participants who with a moderate, marked, or complete pathologic response after chemotherapy, SBRT, and one cycle of immunotherapy as determined by surgical margins and residual disease. Tumor response grading Complete response (grade 0): no viable residual cancer cells Marked response (grade 1): single cells or rare small groups of cancer cells Moderate response (grade 2): residual cancer outgrown by fibrosis Poor or no response (grade 3): extensive residual cancer | 7 months |
| FG001 | Phase I - Dose Level 2 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| FG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. |
| FG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| FG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. |
| COMPLETED | Patients who had matched pre- and post-treatment tissue for the study's primary immune endpoint analysis are considered as "completed." Post-treatment tissue includes tumor from surgical resection or biopsy of metastatic disease at time of aborted surgery, |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I - Dose Level 1 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| BG001 | Phase I - Dose Level 2 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| BG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. |
| BG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| BG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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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| Region of Enrollment | Count of Participants | Participants |
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| Histology Grade at Diagnosis | Patients' tumor biopsies done at time of diagnosis were reviewed and graded by a pathologist. Possible histologic grades include: well differentiated (least aggressive), well to moderately differentiated, moderately differentiated, moderate to poorly differentiated, and poorly differentiated (most aggressive). Cases where there wasn't enough tumor tissue in the biopsy to assess differentiation are listed as "unknown" | 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 | ||||||||||||||||||||||||||||||||
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| Primary | Study Drug-related Adverse Events | Number of participants who experienced study drug-related toxicities as defined by CTCAE v5.0 | Posted | Count of Participants | Participants | Up to 18 months |
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| Primary | Tumor Immune Response (CD8+ CD137+ Tumor Infiltration) | Number of participants who had >80% increase of infiltration of CD8+CD137+ T cells into their tumors after treatment with SBRT and immunotherapy. Baseline biopsies were collected at time of fiducial placement for SBRT (after completion of chemotherapy) and post-treatment tumor was collected at time of surgical resection | Only patients who completed surgical resection or had a biopsy done at time of aborted surgery and had with matched pre- and post-treatment tumor samples were evaluable for the tumor immune response endpoint. | Posted | Count of Participants | Participants | 7 months |
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| Secondary | Overall Survival (OS) | Number of months from start of immunotherapy until death from any cause | Posted | Median | 95% Confidence Interval | months | 3 years |
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| Secondary | Metastasis Free Survival (MFS) | Number of months from the start of immunotherapy until first documented distant metastases on radiographic imaging or death from any cause, whichever occurs first. | Posted | Median | 90% Confidence Interval | months | 3 years |
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| Secondary | Local Progression Free Survival (LPFS) | Number of months from the start of immunotherapy until first documented local progression on radiographic imaging or death from any cause, whichever occurs first. Local progression is defined as appearance of new lesions in the pancreas or surgical resection bed (for surgically resected patients) or clinically meaningful tumor growth in the primary pancreas tumor (for patients that were not surgically resectable). | Posted | Median | 95% Confidence Interval | months | 3 years |
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| Secondary | Surgical Resectability Rate | Number of participants who are able to undergo successful tumor resection (as defined by R0 and R1 resection). | Posted | Count of Participants | Participants | 7 months |
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| Secondary | Pathological Response Rate | Number of participants who with a moderate, marked, or complete pathologic response after chemotherapy, SBRT, and one cycle of immunotherapy as determined by surgical margins and residual disease. Tumor response grading Complete response (grade 0): no viable residual cancer cells Marked response (grade 1): single cells or rare small groups of cancer cells Moderate response (grade 2): residual cancer outgrown by fibrosis Poor or no response (grade 3): extensive residual cancer | Only participants that completed surgical resection were evaluable for pathologic response | Posted | Count of Participants | Participants | 7 months |
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Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
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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 | Phase I - Dose Level 1 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. | 2 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Phase I - Dose Level 2 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. | 5 | 6 | 2 | 6 | 6 | 6 |
| EG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. | 4 | 5 | 0 | 5 | 5 | 5 |
| EG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. | 5 | 5 | 2 | 5 | 5 | 5 |
| EG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. | 2 | 3 | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| gastric ulcer | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Bacteremia | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Biliary tract infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Encephalopathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Blurred vision | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Chills | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Edema limbs | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Malaise | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Pain at site of port | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Shingles | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Skin infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Pancreatic enzymes decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Serum amylase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Weight loss | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urine output decreased | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Mole | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Bruising at vaccine sites | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Erythema at vaccine sites | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Induration at vaccine sites | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pruritus at vaccine sites | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Swelling at vaccine sites | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Tenderness at vaccine sites | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Christenson, MD | Sidney Kimmel Cancer Center at Johns Hopkins | 410-955-8893 | echris14@jhmi.edu |
| Feb 26, 2026 |
| Prot_SAP_000.pdf |
Not provided
| 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 |
|---|---|
| D016634 | Radiosurgery |
| D000077594 | Nivolumab |
| C570874 | BMS-813160 |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| 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
| 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 |
|
| Moderate to Poorly Differentiated |
|
| Poorly Differentiated |
|
| Unknown |
|
| Hyperthyroidism |
|
| Diarrhea |
|
| Dry mouth |
|
| Nausea |
|
| Stomach pain |
|
| Vomiting |
|
| Chills |
|
| Edema limbs |
|
| Fatigue |
|
| Fever |
|
| Malaise |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Alkaline phosphatase increased |
|
| Lymphocyte account decreased |
|
| Anorexia |
|
| Dehydration |
|
| Back pain |
|
| Myalgia |
|
| Dizziness |
|
| Headache |
|
| Dysuria |
|
| Urine output decreased |
|
| Cough |
|
| Dyspnea |
|
| Pneumonitis |
|
| Dry skin |
|
| Erythema mutliforme |
|
| Pruritus |
|
| Rash maculo-papular |
|
| Bruising at vaccine sites |
|
| Erythema at vaccine sites |
|
| Induration at vaccine sites |
|
| Pruritus at vaccine sites |
|
| Swelling at vaccine sites |
|
| Tenderness at vaccine sites |
|
| Phase I - Dose Level 2 |
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| OG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. |
| OG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| OG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. |
|
|
| OG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. |
| OG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| OG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. |
|
|
| OG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. |
| OG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| OG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. |
|
|
| OG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. |
| OG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| OG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. |
|
|
| OG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. |
| OG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| OG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. |
|
|
| Phase I - Dose Level 2 |
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| OG002 | Phase II - Arm A: Nivolumab + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses. |
| OG003 | Phase II - Arm B: Nivolumab + GVAX + BMS-813160 | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle). Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once. |
| OG004 | Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) | Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability). Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy. Immunotherapy: BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5. Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease). Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once. |
|
|