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

Learn more about:
Related Clinical Trial
Liver Embolization Approaches for Tumor Management Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status in Cholangiocarcinoma Patients Evaluation of the Patient’s Experience in Medical Studies for Cholangiocarcinoma Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials Advanced or Metastatic Cholangiocarcinoma Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction An Exploratory Clinical Study of Photodynamic Therapy Combined With Sonodynamic Therapy in Cholangiocarcinoma Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma FLUOPANC-trial – Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1 Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma QoL After Liver Surgery CH-EUS in Diagnosis of Inoperable Bile Duct Tumors Treatment of ARB202 Advanced Gastrointestinal Cancer Patients Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines. GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma. Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors Molecular Epidemiology of Biliary Tree Cancers Prognostic Factors in Periampullary Tumors and Cysts RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor HLA Typing and Tumor Neoantigen Identification for a Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor Deep Liver Phenotyping and Immunology Study A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry. Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone Crossover Relative Bioavailability and Dose Escalation Study of TT-00420 Tablet in Patients With Advanced Solid Tumors Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer Open-Label Study for Safety, Tolerability, PK and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma LYT-200 Alone and in Combination With Chemotherapy or Anti-PD-1 in Patients With Metastatic Solid Tumors Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer Phase I/II Study Evaluating Safety and Efficacy of Tivozanib (AV-951) in Cholangiocarcinoma ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY Recurrence After Whipple’s (RAW): Retrospective Cohort Study Investigating Patterns of Cancer Recurrence Following Pancreaticoduodenectomy for Pancreatic Head Malignancy Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care Prospective Evaluation of Biliary Tissue Sampling With ERCP Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture Liver Cancer Registry Platform Target Rare Cancer Knowledge Neoadjuvant Therapy in Biliary Adenocarcinoma BOLD-100 in Combination With FOLFOX for the Treatment of Advanced, Solid Tumours the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery Efficacy of Fistulotomy for Biliary Cannulation A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors Etomidate vs. Midazolam for Sedation During ERCP Loop-tipped Guidewire in Selective Biliary Cannulation Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT) Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm BKM120 in Cancers With PIK3CA Activating Mutations A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT PTFE Stents for Treatment of Malignant Biliary Strictures Irreversible Electroporation of Unresectable Liver Tumors Personal Resilience Empowerment Program Study Radiofrequency Ablation for Biliopancreatic Malignancy Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer In Vitro Models of Liver and Pancreatic Cancer Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter Evaluation of Stereotactic Radiosurgery For Liver Malignancies Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD Margin Status After Pancreaticoduodenectomy for Cancer A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer A Study of TRK-950 in Patients With Advanced Solid Tumors Combined HCC-MFCCC Proton Therapy and Bevacizumab for Primary Liver Tumors Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases Fluorescence QRH-882260 Peptide Imaging in the Bile Duct A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer MRCP Diagnoses EHCC Better When Combined DWI Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours Comparison of Biliary Forceps Biopsy and Brush Cytology 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 Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer Endobiliary RFA for Unresectable Malignant Biliary Strictures A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma Clinical Effect and Safety of PDT and RFA for Unresectable EHCC Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma Trial of IRE in Cholangiocarcinoma Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer S-1 in Combination With Abraxane in Treating Cholangiocarcinoma Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy – (FIGHT-202) Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Study of Pembrolizumab and Olaparib in Bile Duct Cancer Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma ncRNAs in Exosomes of Cholangiocarcinoma Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

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 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.
    

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, 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants With Disease Recurrence At 1 Year

Secondary Outcome

 Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873

Condition

Colon Cancer

Intervention

MVT-5873

Study Arms / Comparison Groups

 Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
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

10

Start Date

November 13, 2019

Completion Date

May 27, 2022

Primary Completion Date

May 27, 2022

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 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)*

               -  Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase
                  (SGOT)/alanine aminotransferase (ALT) serum glutamate-pyruvate transaminase
                  (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 (HuMab-5B1) 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., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03801915

Organization ID

190039

Secondary IDs

19-C-0039

Responsible Party

Principal Investigator

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

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


Verification Date

February 2023