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A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer (EMERGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01156753
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
Celldex Therapeutics

Brief Summary:
The main purpose of this study is to see whether CDX-011 is effective in treating patients who have advanced breast cancer that makes a protein called glycoprotein NMB (GPNMB), and who have already received (or were not candidates for) all available approved therapies for their breast cancer. This study will also further characterize the safety of CDX-011 treatment in this patient population.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: CDX-011 Drug: "Investigator's Choice" chemotherapy Phase 2

Detailed Description:

CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (GPNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death.

This study will examine the effectiveness and safety of CDX-011 in patients with advanced breast cancer that makes the GPNMB protein. To better assess this, the effect of CDX-011 will be compared to treatment with currently available cancer chemotherapy.

Eligible patients who enroll in the study will be randomly assigned by chance to receive treatment with CDX-011 or with a chemotherapy chosen by their study doctor from a list of currently available drugs ("Investigator's Choice" chemotherapy). For each three patients enrolled, two will receive CDX-011 and one will receive treatment with "Investigator's Choice". Patients initially assigned to "Investigator's Choice" chemotherapy may be offered treatment with CDX-011 if their cancer worsens during this initial treatment.

All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment, and for any side effects that may occur.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
Study Start Date : July 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: CDX-011 Drug: CDX-011
CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle.

Active Comparator: "Investigator's Choice" chemotherapy Drug: "Investigator's Choice" chemotherapy
Any of the following single-agent chemotherapy may be given at the discretion of the investigator, with a cycle length not to exceed four weeks: Capecitabine, Vinorelbine, Gemcitabine, Docetaxel, Paclitaxel, Albumin-bound paclitaxel, Doxorubicin HCL, Liposomal doxorubicin, Ixabepilone and Eribulin.

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 6 or more weeks following treatment initiation ]
    The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: At least 18 months following treatment initiation ]
    Progression-free survival is defined as the time from randomization to the earlier of disease progression or death due to any cause.

  2. Adverse Events [ Time Frame: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or "Investigator's Choice" chemotherapy and 3 to 4 weeks of follow-up) ]
    The number and percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible for the study:

  1. 18 years of age or older.
  2. Locally advanced or metastatic breast cancer.
  3. Previous treatment with at least two but no more than seven prior chemotherapy treatments for progressive, recurrent or metastatic breast cancer.
  4. Unless not a candidate for these agents, prior therapies must have included a taxane, an anthracycline, and capecitabine, as well as trastuzumab and lapatinib for patients whose tumors are positive for the human epidermal growth factor receptor 2 (HER2). (Patients who received incomplete courses of therapy with these agents due to intolerance will be eligible.)
  5. Breast cancer tumor confirmed to express GPNMB. This will be determined by submitting a tissue sample (obtained during a diagnostic biopsy or surgery) to a central laboratory for analysis.

Exclusion Criteria:

Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:

  1. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
  2. Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
  3. Significant cardiovascular disease or any other underlying medical condition that, in the Investigator's opinion, will make the administration of study treatment (CDX-011 or chemotherapy) hazardous or would obscure the interpretation of side effects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01156753

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Sponsors and Collaborators
Celldex Therapeutics
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Responsible Party: Celldex Therapeutics Identifier: NCT01156753    
Other Study ID Numbers: CDX011-03
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Keywords provided by Celldex Therapeutics:
locally advanced breast cancer
metastatic breast cancer
breast cancer
Targeted treatment for breast cancer
Locally advanced or metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Glembatumumab vedotin
Antineoplastic Agents, Immunological
Antineoplastic Agents