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MVT-5873 for Bile Duct Cancer
Phase 2
Waitlist Available
Led By Jonathan M Hernandez, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary tumors of the pancreas
Primary tumors of the bile duct and ampulla
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
Eligible Conditions
- Bile Duct Cancer
- Pancreatic Cancer
- Colon Cancer
- Liver Metastases
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Number of Participants With Disease Recurrence At 1 Year
Secondary outcome measures
Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Side effects data
From 2022 Phase 2 trial • 10 Patients • NCT03801915100%
Pleural effusion
100%
Hepatobiliary disorders - Other, Bile duct perforation
100%
Aspartate aminotransferase increased
100%
Blood bilirubin increased
100%
Creatinine increased
100%
Somnolence
100%
Urine output decreased
100%
Vomiting
100%
Abdominal infection
100%
Abdominal pain
100%
Confusion
100%
Lymphocyte count decreased
100%
Hyperkalemia
100%
Hypotension
100%
Alkaline phosphatase increased
100%
Alanine aminotransferase increased
100%
Anemia
100%
Dyspnea
100%
Hypoalbuminemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)Experimental Treatment2 Interventions
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
Group II: Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)Experimental Treatment2 Interventions
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MVT-5873
2019
Completed Phase 2
~10
pancreatectomy or hepatectomy
2019
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,636 Total Patients Enrolled
Jonathan M Hernandez, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
112 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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