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| Name | Class |
|---|---|
| Bavarian Nordic | INDUSTRY |
| Hoosier Cancer Research Network | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
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This is a multi-center Phase II randomized study. We plan to enroll 78 patients with biopsy-proven hepatic-limited metastatic colorectal cancer deemed resectable after multi-disciplinary discussion. Eligible patients must have confirmed isolated liver metastases by radiographic imaging of the investigators' choosing. Imaging must include the chest, abdomen, and pelvis regardless of imaging modality chosen. Patients will be randomized to either the control arm or the experimental arm. The control arm will receive mFOLFOX6 every 2 weeks for 4 cycles concurrently with Nivolumab. The experimental arm will first be treated with 2 vaccinations of MVA-BN-CV301 given two weeks apart (Days -28, -14) concurrently with Nivolumab followed by 4 vaccinations of FPV-CV301 given two weeks apart concurrently with mFOLFOX6 and Nivolumab, which will again be administered every 2 weeks for 4 cycles (FPV-CV301, mFOLFOX6 and Nivolumab) After Cycle 4, patients will be re-evaluated for surgical resection by re-staging CT chest, abdomen and pelvis (C/A/P). Patients still considered resectable will undergo surgical resection with the goal of complete resection. Patients who cannot be completely resected will continue to be followed on study, and an additional appropriate candidate will be randomized to the corresponding arm.
We will collect peripheral blood and tumor tissue at the time of surgical resection, if applicable, or by re-biopsy if resection is not possible. Post-operative therapy will begin when patients are deemed ready by their surgical oncologist team. Patients in the control arm will then undergo another 8 cycles of mFOLFOX6 with Nivolumab administered concurrently. Nivolumab will then be administered every four weeks. The experimental arm will receive the same post-operative regimen but including FPV-CV301 boosters given concurrently with mFOLFOX6 and Nivolumab. FPV-CV301 will then be administered every 12 weeks, and Nivolumab every 4 weeks. We will collect peripheral blood for evaluation of correlates upon the completion of therapy. The vaccination approach of initial immunization during the neoadjuvant period followed by FPV-CV301 boosters for two years postoperatively was chosen to optimize the induction of a long-lasting tumor-specific host response. Neoadjuvant vaccination will also allow for analysis of the tumor microenvironment in resection specimens.
Post-therapy patients will be under surveillance per NCCN guidelines with repeat CEA every 3 months for 2 years followed by every 6 months for 1 year (total 3 years), repeat CT of the C/A/P every 3 months for 2 years followed by every 6 months for up to 1 year (total 3 years), and colonoscopy at one year with repetition based on findings at the time of the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Control | Active Comparator | mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Patients still considered resectable will undergo surgical resection with the goal of completely treating all of their disease by either resection and/or ablation. Patients with bilobar disease must have all of their disease treated in a single operation. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110. |
|
| Arm B - Experimental | Experimental | Two doses of Nivolumab and MVA-BN-CV301 each given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6, which will again be administered every 2 weeks for 4 cycles (Nivolumab, FPV-CV301 and mFOLFOX6). After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Patients still considered resectable will undergo surgical resection with the goal of completely treating all of their disease by either resection and/or ablation. Patients with bilobar disease must have all of their disease treated in a single operation. Patients in the experimental arm will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks. FVP-CV301 will then be administered every twelve weeks completing therapy at week 110. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mFOLFOX6 | Drug | The control arm (Arm A) and experimental arm (Arm B) will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Overall Survival (OS) Rate From Metastasectomy | 3-year Overall Survival (OS) rate is defined as the percentage of patients who are still alive at 3 years. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-Year Recurrence Free Survival (RFS) Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. The 3-year recurrence-free survival (RFS) rate is defined as the percentage of patients who have not experienced disease recurrence three years after treatment, as calculated using Kaplan-Meier survival analysis. |
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Inclusion Criteria:
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of ≤ 2 and/or sufficient to undergo both perioperative systemic chemotherapy and hepatic surgery as determined by surgical and medical oncology evaluations.
Histologically confirmed hepatic-limited metastatic colorectal cancer.
Genomic testing results are required. FoundationOne platform is preferred, however results from an equivalent genomic platform may be used after discussion with the sponsor investigator.
Completely resectable disease as determined by the guidelines below and surgical oncology evaluation. Patients with bilobar disease that requires resection and ablation are allowed provided the surgical oncologist can render the patient NED (no evidence of disease) at the conclusion of the operation. Synchronous primary colorectal and metastatic hepatic tumors are eligible, provided all disease can be resected in a single operation. NOTE: Subjects who had surgery for their primary tumor prior to registration to this trial are still eligible. Additionally:
Patients with synchronous metastatic disease are allowed provided their primary tumor can be completely resected at the time of metastasectomy. Neoadjuvant pelvic radiotherapy for rectal cancer is not permitted
Patients must be treatment naïve with respect to their stage IV colorectal cancer. History of prior adjuvant systemic chemotherapy containing oxaliplatin is allowed as long as as it has been greater than 12 months from completion of oxaliplatin to study enrollment. NOTE: Neoadjuvant pelvic chemoradiotherapy as part of the management of synchronous metastatic rectal cancer is allowed, provided chemoradiation was completed prior to enrollment on study.
Hematological:
Renal:
o Creatinine < 1.5 x ULN OR Calculated Creatinine Clearance ≥ 60 mL/min
Hepatic:
Females of childbearing potential must have a negative serum pregnancy test within 24 hours of study drug. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months without another cause, or a documented serum follicle stimulating hormone (FSH) ≥ 35 mIU/mL. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Females of childbearing potential and male participants must be willing to abstain from heterosexual intercourse or to use contraception as outlined in the protocol.
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Boland, M.D. | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of Miami |
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| Label | URL |
|---|---|
| Hoosier Cancer Research Network Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A - Control | mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110. mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX. |
| 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 | May 2, 2022 |
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Open-Label
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| MVA-BN-CV301 | Biological | The experimental arm (Arm B) will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14. |
|
|
| FPV-CV301 | Biological | The experimental arm (Arm B) will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy (at least an hour prior to chemotherapy) on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110. |
|
|
| Nivolumab | Drug | Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX. |
|
|
| 3 years |
| Overall Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR | Up to 57 months |
| Patients Amenable to Complete Resection/Ablation | Compare the percentage of patients amenable to complete resection/ablation between the experimental and control treatment groups in patients who experience a recurrence after surgery | Up to 57 months |
| Perioperative Surgical Outcomes | The Clavien-Dindo classification will be used for grading the severity of postoperative complications. It provides a standardized way to report and compare surgical outcomes, based on the therapy required to treat a complication. It grades from 1 to 5 where 1= Any deviation from normal postoperative course without need for pharmacological, surgical, endoscopic, or radiological interventions. Acceptable treatments: antiemetics, antipyretics, analgesics, physiotherapy, wound dressings. 2 = Requires pharmacological treatment with drugs other than those allowed for Grade 1. Includes blood transfusions, antibiotics and total parenteral nutrition (TPN). 3 = Requiring surgical, endoscoptic or radiological intervention. 3a = Intervention under regional/local anesthesia. 3b = Intervention under general anesthesia. 4= Life-threatening complication requiring intensive care/intensive care unit management.4a= Single organ dysfunction. 4b= Multi-organ dysfunction. 5 = Patient demise. | Up to 6 months |
| 3-Year Overall Survival (OS) Rate From Registration | 3-Year OS (Overall Survival) rate is defined as the percentage of patients who are still alive at 3 years. | 3 years |
| Pathologic Response Rate | Compare the pathologic response rate to neoadjuvant therapy in resected tumor tissue between the experimental and control groups. Pathologic Response Rate refers to the percentage of patients whose tumors show a specific level of response after it has been surgically removed. | Up to 6 months |
| Miami |
| Florida |
| 33136 |
| United States |
| University of Kansas Medical Center Research Institute, Inc. | Westwood | Kansas | 66205 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| FG001 | Arm B - Experimental | Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks. mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6. MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14. FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A - Control | mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110. mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX. |
| BG001 | Arm B - Experimental | Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks. mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6. MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14. FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| ECOG Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead: 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. | 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 | 3-year Overall Survival (OS) Rate From Metastasectomy | 3-year Overall Survival (OS) rate is defined as the percentage of patients who are still alive at 3 years. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall survival was defined as all patients receive one dose of protocol therapy and are completely resected. | Posted | Number | Percentage of participants | 3 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 3-Year Recurrence Free Survival (RFS) Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. The 3-year recurrence-free survival (RFS) rate is defined as the percentage of patients who have not experienced disease recurrence three years after treatment, as calculated using Kaplan-Meier survival analysis. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Recurrence free survival was defined as all patients receive one dose of protocol therapy and are completely resected. | Posted | Number | Percentage of participants | 3 years |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR | In accordance with the Statistical Analysis Plan, the analysis population for the endpoints Overall Response Rate was defined as all patients receive one dose of protocol therapy and are completely resected. | Posted | Number | Percentage of participants | Up to 57 months |
| |||||||||||||||||||||||||||||||
| Secondary | Patients Amenable to Complete Resection/Ablation | Compare the percentage of patients amenable to complete resection/ablation between the experimental and control treatment groups in patients who experience a recurrence after surgery | In accordance with the Statistical Analysis Plan, the analysis population for the endpoints Percentage of patients amenable to complete resection/ablation was defined as all patients who experience a recurrence after surgery. | Posted | Number | Percentage of participants | Up to 57 months |
| |||||||||||||||||||||||||||||||
| Secondary | Perioperative Surgical Outcomes | The Clavien-Dindo classification will be used for grading the severity of postoperative complications. It provides a standardized way to report and compare surgical outcomes, based on the therapy required to treat a complication. It grades from 1 to 5 where 1= Any deviation from normal postoperative course without need for pharmacological, surgical, endoscopic, or radiological interventions. Acceptable treatments: antiemetics, antipyretics, analgesics, physiotherapy, wound dressings. 2 = Requires pharmacological treatment with drugs other than those allowed for Grade 1. Includes blood transfusions, antibiotics and total parenteral nutrition (TPN). 3 = Requiring surgical, endoscoptic or radiological intervention. 3a = Intervention under regional/local anesthesia. 3b = Intervention under general anesthesia. 4= Life-threatening complication requiring intensive care/intensive care unit management.4a= Single organ dysfunction. 4b= Multi-organ dysfunction. 5 = Patient demise. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoints Perioperative Surgical Outcomes was defined as all patients receive one dose of protocol therapy and are completely resected. | Posted | Count of Participants | Participants | Up to 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | 3-Year Overall Survival (OS) Rate From Registration | 3-Year OS (Overall Survival) rate is defined as the percentage of patients who are still alive at 3 years. | Posted | Number | Percentage of participants | 3 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Pathologic Response Rate | Compare the pathologic response rate to neoadjuvant therapy in resected tumor tissue between the experimental and control groups. Pathologic Response Rate refers to the percentage of patients whose tumors show a specific level of response after it has been surgically removed. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoints pathologic response was defined as all patients receive one dose of protocol therapy and are completely resected. | Posted | Number | Percentage of participants | Up to 6 months |
|
Up to 5 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 | Arm A - Control | mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110. mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX. | 0 | 8 | 6 | 8 | 8 | 8 |
| EG001 | Arm B - Experimental | Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks. mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6. MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14. FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. | 1 | 9 | 5 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| COLONIC OBSTRUCTION | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | Surgical and medical procedures | CTCAEv5 | Non-systematic Assessment |
| |
| THROMBOEMBOLIC EVENT | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| VASCULAR DISORDERS - OTHER, SPECIFY | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | CTCAEv5 | Non-systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ALKALINE PHOSPHATASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ANEMIA | Blood and lymphatic system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| BLOATING | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | Blood and lymphatic system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| BLURRED VISION | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BRUISING | Injury, poisoning and procedural complications | CTCAEv5 | Non-systematic Assessment |
| |
| CHILLS | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CONCENTRATION IMPAIRMENT | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CREATININE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| EDEMA LIMBS | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FEVER | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| GASTROINTESTINAL PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEMATOMA | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEMATURIA | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEMORRHOIDS | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERNATREMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOGLYCEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | CTCAEv5 | Non-systematic Assessment |
| |
| IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY | Immune system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INR INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INVESTIGATIONS - OTHER, SPECIFY | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| LIPASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| MUCOSITIS ORAL | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PAIN | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PARESTHESIA | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PHOTOPHOBIA | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RECTAL HEMORRHAGE | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SERUM AMYLASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| THROMBOEMBOLIC EVENT | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| URINARY FREQUENCY | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| URINARY TRACT PAIN | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| WEIGHT GAIN | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| WEIGHT LOSS | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| WHITE BLOOD CELL DECREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BLADDER SPASM | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CARDIAC DISORDERS - OTHER, SPECIFY | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CONFUSION | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CPK INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DRY EYE | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ERYTHRODERMA | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| EYE DISORDERS - OTHER, SPECIFY | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FLU LIKE SYMPTOMS | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FLUSHING | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HOARSENESS | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HOT FLASHES | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERCALCEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERMAGNESEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY | Injury, poisoning and procedural complications | CTCAEv5 | Non-systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MALAISE | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MUSCLE WEAKNESS TRUNK | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NAIL LOSS | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RASH ACNEIFORM | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SINUS BRADYCARDIA | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
| |
| STOMACH PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | CTCAEv5 | Non-systematic Assessment |
| |
| TREMOR | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| VASCULAR DISORDERS - OTHER, SPECIFY | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| WOUND COMPLICATION | Injury, poisoning and procedural complications | CTCAEv5 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fauzia Sharmin | Hoosier Cancer Research Network | 317-921-2050 | fsharmin@hoosiercancer.org |
| May 1, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D005586 | Fowlpox |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C527606 | smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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 |
|
| ECOG = 1 |
|
| OG001 | Arm B - Experimental | Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks. mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6. MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14. FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. |
|
|
| OG001 |
| Arm B - Experimental |
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks. mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6. MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14. FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. |
|
|
|
|
| OG001 | Arm B - Experimental | Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks. mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6. MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14. FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110. Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. |
|
|
|
|
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|