FPV-CV301 for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Colorectal Cancer+1 More
FPV-CV301 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Colorectal Cancer
  • Metastatic Colorectal Cancer (CRC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 8 Secondary · Reporting Duration: 3 years

3 years
Evaluate Best Overall Response Rate (ORR)
Evaluate Overall Response Rate (ORR)
Evaluate the perioperative surgical outcomes
Evaluate the proportion of patients amenable to complete resection/ablation
Overall Survival (OS)
Pathologic Complete Response
Progression Free Survival (PFS)
Recurrence free survival (RFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm A - Control
1 of 2
Arm B - Experimental
1 of 2

Active Control

Experimental Treatment

78 Total Participants · 2 Treatment Groups

Primary Treatment: FPV-CV301 · No Placebo Group · Phase 2

Arm B - ExperimentalExperimental Group · 4 Interventions: mFOLFOX6, Nivolumab, FPV-CV301, MVA-BN-CV301 · Intervention Types: Drug, Drug, Biological, Biological
Arm A - ControlActiveComparator Group · 2 Interventions: mFOLFOX6, Nivolumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFOX6
2009
Completed Phase 4
~1130
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Kristen SpencerLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,483 Previous Clinical Trials
3,919,798 Total Patients Enrolled
Bavarian NordicIndustry Sponsor
49 Previous Clinical Trials
37,758 Total Patients Enrolled
Patrick BolandLead Sponsor
Hoosier Cancer Research NetworkOTHER
66 Previous Clinical Trials
3,798 Total Patients Enrolled
Patrick Boland, M.D.Principal InvestigatorRutgers Cancer Institute of New Jersey
Kristen N Spencer, M.D.Principal InvestigatorRutgers Cancer Institute of New Jersey

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The individual has an ECOG performance status of 2 or less, which means they are healthy enough to have surgery and to receive chemotherapy treatment
Investigators are required to have genomic testing results for their study participants
A platelet count of 100,000 mm^3 or greater is considered normal.
Cancer that has spread to the liver, but is limited to that organ, as confirmed by histology.
There is no evidence of involvement of the extrahepatic bile ducts, main portal vein, or celiac/retroperitoneal lymph nodes on the radiographs.
People with stage IV colorectal cancer must not have received any earlier treatment with chemotherapy containing oxaliplatin
Before you can register for classes, you must sign a form that authorizes the college to release your personal health information
The person must be at least 18 years old when they give consent.
The text states that the individual site surgical oncologists deem an adequate predicted functional liver remnant.
Patients with synchronous metastatic disease are allowed provided their primary tumor can be completely resected at the time of metastasectomy

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.