Metastatic Colorectal CancerPhase 2NCT03547999
A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC
A Phase 2 study testing mFOLFOX6, MVA-BN-CV301 and FPV-CV301 in people with Metastatic Colorectal Cancer, run by Patrick Boland at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- mFOLFOX6, MVA-BN-CV301 and FPV-CV301
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Jun 2018to 13 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- No radiographic evidence of involvement of: extrahepatic bile ducts, main portal vein or celiac/retroperitoneal lymph nodes.
- Adequate predicted functional liver remnant (FLR) as deemed by the individual site surgical oncologists.
- 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:
- Platelet Count ≥ 100,000 mm^3
- Absolute Neutrophil Count (ANC) ≥1500 µ/L
- Hemoglobin (Hgb) ≥ 9 g/dL
- Renal:
- o Creatinine < 1.5 x ULN OR Calculated Creatinine Clearance ≥ 60 mL/min
- Hepatic:
- Total Bilirubin ≤ 1.5 × upper limit of normal (ULN)^2
- Aspartate aminotransferase (AST) ≤ 5 × ULN; given presence of liver metastases
- Alanine aminotransferase (ALT) ≤ 5 × ULN; given presence of liver metastases
- Alkaline Phosphatase < 2.5 x ULN
- INR, PT, or APTT ≤ 1.5x ULN unless participant is receiving anticoagulant therapy, in which case they must be on a stable dose
- 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.
Who cannot join
- Patients with mutations in or deficient expression of one or more of the mismatch repair genes listed: MSH2, MSH3, MSH6, MLH1, PMS1, PMS2.
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding.
- Second primary malignancy. Clear exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years and, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix). Patients with chronic lymphocytic leukemia will be allowed if their blood counts are within acceptable hematologic parameters and if they are not currently requiring cytotoxic or biologic anticancer treatment (supportive treatment such as IVIG is permitted).
- Metastatic disease not limited to the liver.
- Disease not amenable to complete resection, not resectable within the confines of a single surgery, or where resection would result in inadequate functional liver remnant.
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- Prior surgery or systemic therapy for colorectal cancer within 6 months or 12 months if systemic chemotherapy included oxaliplatin of study enrollment.
- Immunodeficient patients including but not limited to patients with HIV/AIDS and chronic Hepatitis B and C.
- Patient with clinically significant cardiomyopathy, coronary disease, heart failure New York Heart Association (NYHA) class III or IV, or cerebrovascular accident (CVA) within 1 year of study enrollment (CV301).
- Subjects with known severe allergy to eggs, egg products, or aminoglycoside antibiotics (for example, gentamicin or tobramycin) (CV301).
- Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Participants with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (e.g. Hormone replacement after adrenal crisis)
- Excluding patients with serious or uncontrolled medical disorders
- Treatment with botanical preparations (e.g. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment.
- History of allergy or hypersensitivity to study drug components.
- History of allogenic stem cell or solid organ transplant.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
University of Miami
Miami, Florida, 33136
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Oregon Health & Science University
Portland, Oregon, 97239
University of Kansas Medical Center Research Institute, Inc.
Westwood, Kansas, 66205
About this study
Official title: A Phase II Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Resectable Hepatic-Limited Metastatic Colorectal Cancer HCRN: GI16-288
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- mFOLFOX6, MVA-BN-CV301, FPV-CV301, Nivolumab
- Keywords
- CV301 Vaccination, mFOLFOX6, Fowlpox (FP)-CV301, nivolumab, MVA-BN-CV301
- Medical subject headings
- Colorectal Neoplasms, Fowlpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX6Drug
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.
MVA-BN-CV301Biological
Also called Modified Vaccinia Ankara, CV301
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-CV301Biological
Also called Fowl Pox Virus
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.
NivolumabDrug
Also called Opdivo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: mFOLFOX6; Drug: Nivolumab |
| 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. Receives: Drug: mFOLFOX6; Biological: MVA-BN-CV301; Biological: FPV-CV301; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start26 Jun 2018
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Why it stopped: Drugs Unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Boland
- Sponsor type
- University, hospital or other
- Collaborators
- Bavarian Nordic, Hoosier Cancer Research Network, Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Patrick Boland, Hoosier Cancer Research Network
- Investigators
- Patrick Boland, M.D., Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547999
- Sponsor's protocol ID
- HCRN GI16-288
- Status last verified
- Jul 2025
- First submitted
- 23 May 2018
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Resectable Hepatic-Limited Metastatic Colorectal Cancer HCRN: GI16-288
- ClinicalTrials.gov ID
- NCT03547999
- Acronym / sponsor ID
- HCRN GI16-288
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- CV301 Vaccination, mFOLFOX6, Fowlpox (FP)-CV301, nivolumab, MVA-BN-CV301
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drugs Unavailable
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Patrick BolandUniversity, hospital or other
- Collaborators
- Bavarian Nordic, Hoosier Cancer Research Network, Bristol-Myers Squibb
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 22 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Control | Active comparator | Drug: mFOLFOX6, Drug: NivolumabmFOLFOX6 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 | Drug: mFOLFOX6, Biological: MVA-BN-CV301, Biological: FPV-CV301, Drug: NivolumabTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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.
Key exclusion criteria (18 listed)
- Patients with mutations in or deficient expression of one or more of the mismatch repair genes listed: MSH2, MSH3, MSH6, MLH1, PMS1, PMS2.
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding.
- Second primary malignancy. Clear exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years and, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix). Patients with chronic lymphocytic leukemia will be allowed if their blood counts are within acceptable hematologic parameters and if they are not currently requiring cytotoxic or biologic anticancer treatment (supportive treatment such as IVIG is permitted).
- Metastatic disease not limited to the liver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFOX6The 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. | Drug | Arm A - Control, Arm B - Experimental |
| MVA-BN-CV301Also: Modified Vaccinia Ankara, CV301The 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. | Biological | Arm B - Experimental |
| FPV-CV301Also: Fowl Pox VirusThe 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. | Biological | Arm B - Experimental |
| NivolumabAlso: OpdivoNivolumab 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. | Drug | Arm A - Control, Arm B - Experimental |
Primary outcome
3-year Overall Survival (OS) Rate From Metastasectomy
Time frame: 3 years
3-year Overall Survival (OS) rate is defined as the percentage of patients who are still alive at 3 years.
6 secondary outcomes
3-Year Recurrence Free Survival (RFS) Rate
Time frame: 3 years
Overall Response Rate (ORR)
Time frame: Up to 57 months
Patients Amenable to Complete Resection/Ablation
Time frame: Up to 57 months
Perioperative Surgical Outcomes
Time frame: Up to 6 months
3-Year Overall Survival (OS) Rate From Registration
Time frame: 3 years
Pathologic Response Rate
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Boland, M.D. principal investigator
Rutgers Cancer Institute of New Jersey
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFOX6, MVA-BN-CV301 and FPV-CV301 in people with Metastatic Colorectal Cancer, run by Patrick Boland at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Overall Survival (OS) Rate From Metastasectomy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.