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

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Brief Title

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

Official Title

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

Brief Summary

      Background:

      Gastrointestinal tumors have a molecule called 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.
    

Detailed Description

      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, CA 19-9.

        -  MVT-5873, a fully human antibody against Sialyl Lewis, has displayed ADCC and CDC in
           vitro, potentiated chemotherapeutic efficacy in mouse models and demonstrated efficacy
           in Phase 1 trials of patients with advanced inoperable HPB cancers.

        -  MVT-5873 is well tolerated as a single agent; moderate elevations in AST/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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Determine if perioperative MVT-5873 can decrease 1-year recurrence rates for subjects with operable CA 19-9 producing cancers.

Secondary Outcome

 Define disease free survival (DFS) for subjects treated with preoperative MVT-5873

Condition

Colon Cancer

Intervention

MVT-5873

Study Arms / Comparison Groups

 1/Arm 1
Description:  Pre-operative escalation doses of MVT-5873,pancreatectomy or hepatectomy and post-operative MVT-5873 treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

105

Start Date

November 13, 2019

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2023

Eligibility Criteria

        -  INCLUSION CRITERIA:

          -  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 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.

          -  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 ULN*

               -  AST(SGOT)/ALT(SGPT) <5 X institutional upper limit of normal

               -  creatinine <1.5X institutional upper limit of normal

                    -  Subjects with periampullary cancers typically present with biliary
                       obstruction resulting in significant abnormalities in liver function tests
                       that do not reflect liver dysfunction. These values normalize after tumor
                       removal. They can be normalized pre-operatively with biliary stenting but
                       several large studies have demonstrated an increase in infectious
                       complications with drainage. As such, a practice standard has been to avoid
                       stenting until bilirubin level rises above 10 X ULN.

          -  For subjects with liver tumors (cholangiocarcinoma or metastatic colorectal cancer)
             requiring a hepatectomy for complete tumor extirpation:

               -  total bilirubin <2.5 X institutional upper limit of normal*

               -  AST(SGOT)/ALT(SGPT) <5 X institutional upper limit of normal*

               -  creatinine <1.5X institutional upper limit of normal

                    -  Liver abnormalities in this range are consistent with parenchymal
                       destruction from the tumor.

          -  For subjects with pancreas tumors that require a distal pancreatectomy for
             extirpation:

               -  total bilirubin <1.5 X institutional upper limit of normal*

               -  AST(SGOT)/ALT(SGPT) <2 X institutional upper limit of normal*

               -  creatinine <1.5X institutional upper limit of normal

                    -  Liver abnormalities in this range are consistent with pancreas cancer
                       destruction from the tumor.

          -  The effects of MVT-5873 on the developing human fetus are unknown. For this reason,
             women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation and for 3 months after completion of study
             treatment. Should a woman become pregnant or suspect she is pregnant while she or her
             partner is participating in this study, she should inform her treating physician
             immediately.

          -  Ability of subject to understand and the willingness to sign a written informed
             consent document.

          -  Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor,
             Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection
             of Solid Tumors .

        EXCLUSION CRITERIA:

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jonathan M Hernandez, M.D., (240) 409-8860, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03801915

Organization ID

190039

Secondary IDs

19-C-0039

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Jonathan M Hernandez, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

September 17, 2020