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Cancer Vaccine

MVA-BN-CV301 for Colorectal Cancer

Phase 2
Waitlist Available
Led By Kristen N Spencer, M.D.
Research Sponsored by Kristen Spencer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is a multi-center Phase II randomized study of a new cancer treatment. 78 patients with liver metastases from colorectal cancer will be enrolled and randomly assigned to either the control arm or the experimental arm. The control arm will receive the standard of care, while the experimental arm will receive a new immunotherapy treatment in addition to the standard of care. The primary endpoint of the study is to assess the safety and efficacy of the new treatment.

Eligible Conditions
  • Metastatic Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Evaluate Best Overall Response Rate (ORR)
Evaluate the perioperative surgical outcomes
Evaluate the proportion of patients amenable to complete resection/ablation
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B - ExperimentalExperimental Treatment4 Interventions
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.
Group II: Arm A - ControlActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFOX6
2009
Completed Phase 4
~1400
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Kristen SpencerLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,677 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,634 Previous Clinical Trials
4,126,777 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other experiments that have taken place regarding the use of FPV-CV301?

"Presently, there are 733 live clinical trials researching FPV-CV301 with 82 studies in the third phase. The majority of these research endeavours take place in Basel, BE while 40305 other locations are running relevant investigations."

Answered by AI

How many participants have been recruited to partake in this trial?

"For the present moment, this trial has ceased recruitment. Its initial posting was on June 26th 2018 and its most recent edit occurred on July 11th 2022. Should you be seeking out other trials to participate in, 873 studies are actively recruiting patients with colorectal cancer while 733 exploration exist for FPV-CV301."

Answered by AI

How many venues are facilitating this investigation?

"Presently, 7 different research sites are seeking participants for this trial. These include City of Hope in Duarte, Ohio State University Comprehensive Cancer Center in Columbus and Oregon Health & Science University in Portland; as well as 4 additional medical centres."

Answered by AI

To what ailments has FPV-CV301 been indicated as a viable treatment?

"FPV-CV301 is a viable treatment for malignant neoplasms, as well as other medical situations such as advanced melanoma and metastatic esophageal adenocarcinoma."

Answered by AI

What potential dangers does FPV-CV301 pose to human health?

"Our team at Power has evaluated FPV-CV301's safety and determined it to be a 2. This is because the medication is in its second phase of clinical trials, and while there are some findings supporting its security, none could yet confirm efficacy."

Answered by AI

Is this the inaugural instance of such a clinical trial?

"Ono Pharmaceutical Co. Ltd initiated the first trial for FPV-CV301 in 2012, involving 659 participants. Subsequently, this drug received approvals for Phases 1 and 2 of clinical trials, resulting in its current status with 733 active studies conducted across 50 countries and 2354 cities."

Answered by AI

Are there any openings for potential participants in this experiment?

"The clinical trial hosted on clinicaltrials.gov is no longer seeking participants as it was initially posted in June 26th 2018 and last updated July 11th 2022. Nevertheless, there are 1606 other trials actively recruiting patients at this moment."

Answered by AI

Who else is applying?

What site did they apply to?
Rutgers Cancer Institute of New Jersey
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC
Patrick Boland 2018. "A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03547999.
~12 spots leftby Apr 2025
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