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
2 other identifiers
interventional
10
1 country
1
Brief Summary
Background: Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want to learn the highest dose tolerated. They want to see if getting the agent at surgery helps slow down the disease. Objective: To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the progression of the disease. Eligibility: Adults at least 18 years old with certain cancers and certain blood CA19-9 levels Design: Participants will be screened with:
- Medical history
- Physical exam
- Blood and heart tests
- Scans
- Review of normal activities
- Review of tumor sample
- Pregnancy test A few days before surgery, participants will get a dose of the study agent. They will get it through a small plastic tube in a vein over about 2 hours. Participants will sign a separate consent and have the surgery. A sample of the tumor and normal liver will be removed for research. For 1-2 weeks after surgery, participants will recover in intensive care then regular care at the hospital. They will be monitored and treated throughout the stay. After leaving the hospital, participants will get the study agent every week for 1 month. Then they will get it every other week for 2 months. They will repeat screening tests at study visits and at a follow-up visit. That will be about 5 weeks after the last dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2019
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedStudy Start
First participant enrolled
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2022
CompletedResults Posted
Study results publicly available
March 21, 2023
CompletedMarch 21, 2023
February 1, 2023
2.5 years
January 11, 2019
February 27, 2023
February 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Disease Recurrence At 1 Year
Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.
1 year
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.
Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
Secondary Outcomes (1)
Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873
An average of 15.17 months
Other Outcomes (1)
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
Study Arms (2)
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
EXPERIMENTALPre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
EXPERIMENTALPre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
Interventions
1 mg/kg or 3 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
Pancreatectomy or hepatectomy
Eligibility Criteria
You may qualify if:
- Subjects must have histologically or cytologically confirmed diagnoses of adenocarcinoma in one of the following scenarios:
- Primary tumors of the pancreas
- Primary tumors of the bile duct and ampulla
- Metastatic colorectal cancers to the liver
- Subjects must have disease resectable with a standard pancreatectomy (pancreaticoduodenectomy or distal pancreatectomy) or liver resection.
- Subjects may have received prior therapy, including neoadjuvant regimens.
- Subjects must have serum Carbohydrate antigen 19-9 (CA 19-9) elevations greater than the upper limit of normal but less than 2500 U/mL.
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Subjects must have adequate organ and marrow function as defined below:
- leukocytes \>3,000/mcL
- absolute neutrophil count \>1,500/mcL
- platelets \>90,000/mcL
- For subjects with Periampullary cancers that require a pancreaticoduodenectomy for complete tumor extirpation:
- total bilirubin \<10 upper limit of normal (ULN)\*
- +16 more criteria
You may not qualify if:
- Presence of disease outside the confines of a standard operation for subjects with periampullary cancers (pancreatic and cholangiocarcinoma).
- Presence of disease outside the liver for subjects with intrahepatic/hilar cholangiocarcinoma or metastatic colorectal cancer, other than a primary tumor for subjects with metastatic colorectal cancer.
- Subjects who are receiving any other investigational agents.
- Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from the last day of prior anticancer therapy, including chemotherapy, hormonal, investigational, and or biological therapies and irradiation.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
- requirements.
- Active concurrent malignancies within the last five years other than the primary tumor
- in subjects with metastatic colorectal cancer, basal or squamous cell skin carcinoma or non- medullary thyroid carcinoma.
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of the MVT-5873. Because there is an unknown but potential
- Subjects with active, Hepatitis B or C infection because of the potential for increased liver toxicity given the damaging effects of the virus.
- Allergic to chimeric, humanized or human antibodies.
- Received live vaccine within 4 weeks prior to first date of study intervention.
- Infection requiring hospitalization or herpes zoster treatment within 2 weeks prior to the first date of study intervention.
- Long-term infectious diseases (tuberculosis, fungal infections) active within 2 years prior to the first date of study intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
Gupta S, McDonald JD, Ayabe RI, Khan TM, Gamble LA, Sinha S, Hannah C, Blakely AM, Davis JL, Hernandez JM. Targeting CA 19-9 with a humanized monoclonal antibody at the time of surgery may decrease recurrence rates for patients undergoing resections for pancreatic cancer, cholangiocarcinoma and metastatic colorectal cancer. J Gastrointest Oncol. 2020 Apr;11(2):231-235. doi: 10.21037/jgo.2020.02.01.
PMID: 32399263DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jonathan Hernandez
- Organization
- National Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan M Hernandez, M.D.
National Cancer Institute (NCI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
January 11, 2019
First Posted
January 14, 2019
Study Start
November 13, 2019
Primary Completion
May 27, 2022
Study Completion
May 27, 2022
Last Updated
March 21, 2023
Results First Posted
March 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data available during the study and indefinitely. Genomic data is available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
- Access Criteria
- Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).