Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)

April 8, 2022 updated by: Morphotek

A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer

The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tumor endothelial marker-1 also referred to as TEM-1 is expressed in the supportive tissue, as well as, on the cells within the tumor. TEM-1, which is a cell surface glycoprotein, and is expressed in the stromal compartment (cells) of nearly all human tumors. In preclinical studies, it has been shown that TEM-1 plays a key role in tumor growth and the vascularization of tumors. There is evidence suggesting an association between the level of TEM-1, 7, 7R, 8 in relation to lymph node involvement and disease progression. MORAb-004 is a humanized immunoglobulin G (IgG1/κ) antibody directed against endosialin/TEM-1. Nonclinical pharmacological studies showed that MORAb-004 has the ability to block specific TEM-1 receptor-ligand interactions. Immunohistochemistry studies of human tumor biopsy samples demonstrate TEM-1 expression and MORAb-004 binding to tumor stromal cells, in particular mural cell compartment of neovessels and cancer-associated fibroblasts. All of which suggests a potential effective treatment. Researchers hypothesize that an antibody therapy that binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical study is a proof of concept study to see if an anti-TEM-1 agent is safe and effective in the treatment of metastatic, colorectal cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alhambra, California, United States, 91801
        • Central Hem/Onc Medical Group, Inc.
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Burbank, California, United States, 91505
        • Providence St. Joseph Medical Center-Disney Family Cancer Center
      • Fullerton, California, United States, 92835
        • St. Jude Heritage Healthcare
      • Northridge, California, United States, 91328
        • The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center
      • Sacramento, California, United States
        • UC Davis Comprehensive Cancer Center
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94115
        • CPMCRI / Pacific Hematology Oncology Associates
      • Santa Maria, California, United States, 93454
        • Central Coast Medical Oncology
      • Santa Monica, California, United States, 90404
        • UCLA Hematology Oncology
    • Colorado
      • Denver, Colorado, United States, 80224
        • Colorado Cancer Research Program
      • Grand Junction, Colorado, United States, 81501
        • St. Mary'S Hospital Regional Cancer Center
      • Wheat Ridge, Colorado, United States, 80033
        • Lutheran Hematology & Oncology
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida Hematology/Oncology
      • Jacksonville, Florida, United States, 32256
        • Integrated Community Oncology Network / Cancer Specialists of North Florida
      • Orange City, Florida, United States, 32763
        • Compass Research, LLC
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
      • Rockledge, Florida, United States, 32955
        • Cancer Care Centers of Brevard
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center (Moffitt Cancer Center)
    • Georgia
      • Duluth, Georgia, United States, 30096
        • Suburban Hematology-Oncology Associates, P.C.
      • Lawrenceville, Georgia, United States, 30046
        • Suburban Hematology-Oncology Assoc., PC
      • Snellville, Georgia, United States, 30078
        • Suburban Hematology-Oncology Associates, P.C.
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Medical and Surgical Specialists
      • Harvey, Illinois, United States, 60426
        • Ingalls Cancer Research Center
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists,S.C. Center for Advanced Care
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare, P.C.
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Iowa
      • Clive, Iowa, United States, 50325
        • Medical Oncology & Hematology Associates (Clinic #3)
      • Des Moines, Iowa, United States, 50309
        • Iowa Oncology Research Association
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology & Hematology Associates (Clinic #1)
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology & Hematology Associates (Clinic #2)
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
        • John Hopkins University
      • Baltimore, Maryland, United States, 21237
        • Weinberg Cancer Institute at Franklin Square
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University Of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Clinical Oncology Program
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Duluth CCOP
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center/ CentraCare Health Plaza
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota CCOP
      • Saint Louis Park, Minnesota, United States, 55416
        • Regions Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • St. John's Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • CCCN
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital Cancer Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology Associates PA
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One
    • Ohio
      • Cincinnati, Ohio, United States, 45247
        • TriHealth Oncology Institute/Oncology Partners Network
      • Sylvania, Ohio, United States, 43560
        • Hickman Cancer Center at Flower Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Pharma Resource
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • St. Vincent Hospital / Green Bay Oncology
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital / Green Bay Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females >18 years old
  • Diagnosis of metastatic, colorectal cancer
  • Significant medical conditions must be well-controlled and stable for at least 30 days prior to the first treatment infusion
  • Be willing and able to provide written informed consent

Exclusion Criteria:

  • No prior treatment for metastatic colorectal cancer
  • Other serious systemic diseases (bacterial or fungal)
  • Clinically significant heart disease or an arrhythmia on an ECG within the past 6 months
  • Known allergic reaction to monoclonal antibody therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Best supportive care
Best supportive care to improve quality of life
Drug: Placebo
Placebo - normal saline IV once a week
Active Comparator: MORAb-004
Drug: MORAb-004
MORAb-004 8mg per kg IV once a week
Other: Best supportive care
Best supportive care to improve quality of life

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From the date of randomization to the date of the first observation of PD or death due to any cause (up to approximately 1 year 7 months)
PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression (PD) or death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of last tumor assessment without evidence of progression prior to the date of initiation of further antitumor treatment. PFS was summarized for each treatment group using Kaplan-Meier estimation curves.
From the date of randomization to the date of the first observation of PD or death due to any cause (up to approximately 1 year 7 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months)
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. OS was summarized for each treatment group using Kaplan-Meier estimation curves. In the absence of death confirmation or for participants alive at the time of analysis, the survival time was censored at the last date known to be alive.
From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months)
Overall Response Rate (ORR)
Time Frame: From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months)
ORR was defined as the percentage of subjects achieving either CR or PR using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months)
Time to Tumor Response (TTR)
Time Frame: From the date of randomization to first documentation of objective tumor response (CR or PR) (up to approximately 1 year 7 months)
Time to tumor response was defined for those participants with objective evidence of confirmed CR or PR as the time from randomization to first documentation of objective tumor response (CR or PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From the date of randomization to first documentation of objective tumor response (CR or PR) (up to approximately 1 year 7 months)
Duration of Response (DOR)
Time Frame: From the date of first objective response (CR or PR) to objective tumor progression or death regardless of cause (up to approximately 1 year 7 months)
The DOR was defined as the time from first documentation of objective response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From the date of first objective response (CR or PR) to objective tumor progression or death regardless of cause (up to approximately 1 year 7 months)
Biomarkers Based PFS, Within Treatment Group
Time Frame: From the date of randomization up to approximately 1 year 7 months
The statistical evidence to support the use of the biomarker identified in Stage 1 interim analysis for Stage 2 selection of participants as designed was not adequate to clearly define a biomarker responsive population. The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for PFS was not carried out.
From the date of randomization up to approximately 1 year 7 months
Biomarkers Based OS, Within Treatment Group
Time Frame: From the date of randomization up to approximately 1 year 7 months
The statistical evidence to support the use of the biomarker identified in Stage 1 interim analysis for Stage 2 selection of participants as designed was not adequate to clearly define a biomarker responsive population. The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for OS was not carried out.
From the date of randomization up to approximately 1 year 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Morphotek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MORAb-004-202-CRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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