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.
Additional locations may be listed on ClinicalTrials.gov for NCT03801915.
See trial information on ClinicalTrials.gov for a list of participating sites.
Background:
- Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative,
and patients frequently succumb to disease recurrence in the ensuing months to year(s)
after the operation.
- Standard adjuvant therapies, which typically begin 6-12 weeks after surgery, offer
little demonstrable decreases in the rates of tumor recurrence.
- The concept and implementation of immediate perioperative therapy has not been evaluated
given the serious concerns related to healing and recovery with standard cytotoxic
chemotherapy and newer targeted agents.
- A significant percentage of metastatic colorectal cancers, and primary tumors of the
pancreas and bile ducts express Sialyl Lewis, an epitope on the well-established tumor
marker, Carbohydrate antigen 19-9 (CA19-9).
- MVT-5873, a fully human antibody against Sialyl Lewis, has displayed antibody-dependent
cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro,
potentiated chemotherapeutic efficacy in mouse models and demonstrated efficacy in Phase
1 trials of patients with advanced inoperable Hepato-pancreato-biliary (HPB) cancers.
- MVT-5873 is well tolerated as a single agent; moderate elevations in aspartate
aminotransferase (AST)/alanine aminotransferase (ALT) appear to be dose-limiting.
- Patients with resectable Sialyl Lewis-expressing cancers represent an ideal population
to explore the use of perioperative MVT-5873 given moderate level of CA 19-9 elevations,
and the potential for extension of recurrence-free survival.
Objectives:
- Document the safety of perioperative MVT-5873 in patients undergoing pancreas and liver
resections.
- Determine if perioperative MVT-5873 can decrease 1-year recurrence rates for patients
with operable CA 19-9-producing cancers.
Eligibility:
- Histologically or cytologically confirmed adenocarcinoma of the
- Colon (metastatic to liver)
- Pancreas
- Bile Ducts (Cholangiocarcinoma)
- Serum CA19-9 levels greater than the upper limit of normal, but less than 2500.
- Disease amenable to complete surgical extirpation.
Design:
-Pre-operative one-time treatment with MVT-5873, resection to remove all demonstrable disease
in the liver, bile ducts and pancreas, and continuing MVT-5873 mono-therapy until off
treatment criteria are met.
Lead OrganizationNational Cancer Institute
Principal InvestigatorJonathan Matthew Hernandez