Immunotherapy + Chemotherapy for Metastatic Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of new treatment combinations for individuals with liver-limited metastatic colorectal cancer, which has spread from the colon to the liver. Participants will receive either a combination of chemotherapy and immunotherapy (including FPV-CV301 and MVA-BN-CV301) or an experimental treatment that incorporates vaccines with standard care. The researchers aim to determine if these treatments can prepare patients for surgery to remove the cancer. Suitable candidates for this trial have metastatic colorectal cancer confined to the liver and are treatment-naïve for stage IV cancer. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in cancer care.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take certain treatments like corticosteroids or herbal supplements close to the start of the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments in this trial have been studied before, and here is what is known about their safety:
1. **FPV-CV301 and MVA-BN-CV301**: Previous studies found that these vaccines usually caused only minor side effects. The initial doses, MVA-BN-CV301, had more common side effects than the booster doses, FPV-CV301, but these were generally mild.
2. **Nivolumab**: This drug is already approved for treating other types of cancer. Research has shown it to be safe, with the most common serious side effects being diarrhea, pneumonia, and urinary infections, occurring in a small number of patients.
3. **mFOLFOX6**: This chemotherapy combination is widely used and considered safe. Studies report low rates of severe side effects, such as nausea or low blood cell counts, with no deaths related to the treatment.
Overall, these treatments have demonstrated a good safety profile in previous studies, suggesting they are well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine innovative immunotherapy with standard chemotherapy to tackle metastatic colorectal cancer. Unlike the standard approach that typically involves just chemotherapy with drugs like mFOLFOX6, the experimental arm introduces FPV-CV301 and MVA-BN-CV301, which are designed to boost the immune system's response to cancer cells. By adding these immunotherapies to the regimen, scientists hope to enhance the body’s natural ability to fight the cancer, potentially leading to more effective and long-lasting treatment outcomes. This combination aims to improve the effectiveness of treatment by targeting the cancer more aggressively from multiple angles.
What evidence suggests that this trial's treatments could be effective for metastatic colorectal cancer?
Research shows that the combination of MVA-BN-CV301 and FPV-CV301, which participants in the experimental arm of this trial may receive, targets specific proteins found in many tumors, including those in colorectal cancer. These proteins, CEA and MUC1, are linked to tumor growth. Studies indicate that this combination can effectively trigger an immune response, helping the body attack cancer cells. Earlier trials showed that the vaccine is safe and can activate the immune system. Additionally, the combination of chemotherapy (mFOLFOX6) and the immunotherapy drug Nivolumab, which participants in both arms of this trial will receive, has successfully treated this type of cancer. Together, these treatments aim to boost the body's ability to fight cancer more effectively.12456
Who Is on the Research Team?
Patrick Boland, M.D.
Principal Investigator
Rutgers Cancer Institute of New Jersey
Are You a Good Fit for This Trial?
This trial is for adults with colorectal cancer that has spread to the liver but can be surgically removed. They must not have had previous treatment for stage IV cancer, though past oxaliplatin therapy is okay if over a year ago. Participants need proper kidney and liver function, no serious allergies or autoimmune diseases, and women of childbearing age must test negative for pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive either mFOLFOX6 and Nivolumab or MVA-BN-CV301 vaccinations with Nivolumab followed by FPV-CV301, mFOLFOX6, and Nivolumab
Surgical Evaluation and Resection
Patients are re-evaluated for surgical resection and undergo surgery if resectable
Post-operative Treatment
Post-operative therapy with mFOLFOX6 and Nivolumab, with FPV-CV301 boosters in the experimental arm
Follow-up
Participants are monitored for safety and effectiveness after treatment, with surveillance per NCCN guidelines
What Are the Treatments Tested in This Trial?
Interventions
- FPV-CV301
- mFOLFOX6
- MVA-BN-CV301
- Nivolumab
Trial Overview
The study compares two groups: one receiving standard chemotherapy (mFOLFOX6) plus Nivolumab; the other getting additional CV301 vaccinations before and after surgery. The goal is to see if adding the vaccine improves outcomes by inducing a stronger immune response against the tumor.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kristen Spencer
Lead Sponsor
Patrick Boland
Lead Sponsor
Hoosier Cancer Research Network
Collaborator
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Bavarian Nordic
Industry Sponsor
Paul Chaplin
Bavarian Nordic
Chief Executive Officer since 2014
PhD in Immunology from Bristol University
Jean-Christophe May
Bavarian Nordic
Chief Medical Officer since 2020
PharmD and MBA
Citations
Study Details | NCT03547999 | A Trial of Perioperative ...
This is a multi-center Phase II randomized study. We plan to enroll 78 patients with biopsy-proven hepatic-limited metastatic colorectal cancer deemed ...
A Phase 1 Dose-Escalation Trial of BN-CV301, a ...
Altogether these results demonstrated that MVA-BN-CV301 and FPV-CV301 are able to efficiently infect and direct the expression of the encoded transgenes CEA, ...
A Trial of Perioperative CV301 Vaccination in Combination ...
CV301 targets two tumor-associated antigens, CEA and MUC1, which are over-expressed in multiple solid tumors, including lung, bladder and colorectal cancer.
4.
withpower.com
withpower.com/trial/immunotherapy-chemotherapy-for-metastatic-colorectal-cancer-7456fImmunotherapy + Chemotherapy for Metastatic Colorectal ...
This Phase 2 medical study run by Kristen Spencer needs participants to evaluate whether FPV-CV301, mFOLFOX6, MVA-BN-CV301 and Nivolumab will have tolerable ...
Phase 1 trial of CV301 in combination with anti-PD ...
CV301, a poxviral-based vaccine, has been evaluated in a phase 1 clinical trial (NCT02840994) and shown to be safe and immunologically active (phase 1a).
Study Details | NCT03376659 | Durvalumab Plus CV301 ...
This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with ...
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