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

NCT ID: NCT01156753

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-11-30

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CDX-011

Group Type: EXPERIMENTAL

CDX-011

Intervention Type: DRUG

CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle.

"Investigator's Choice" chemotherapy

Group Type: ACTIVE_COMPARATOR

"Investigator's Choice" chemotherapy

Intervention Type: DRUG

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.

Interventions

CDX-011

CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celldex Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Arizona Cancer Center

Tucson, Arizona, United States

Breastlink Medical Group

Long Beach, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Florida Cancer Specialists

West Coast, Florida, United States

Peachtree Hematology-Oncology Consultants PC

Atlanta, Georgia, United States

Georgia Cancer Specialists

Atlanta, Georgia, United States

Orchard Healthcare Research Inc.

Skokie, Illinois, United States

Cancer Treatment Centers of America at Midwestern Regional Medical Center

Zion, Illinois, United States

Cancer Care of Louisiana

New Orleans, Louisiana, United States

Henry Ford Health System

Detroit, Michigan, United States

Montana Cancer Institute Foundation

Missoula, Montana, United States

Clinical Research Alliance Inc.

Lake Success, New York, United States

Weill Cornell Breast Center/Weill Cornell Medical College

New York, New York, United States

Montefiore-Einstein Cancer Center

The Bronx, New York, United States

Levine Cancer Institute/Blumenthal Cancer Center

Charlotte, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Guthrie Clinic, Ltd.

Sayre, Pennsylvania, United States

South Carolina Oncology Associates

Columbia, South Carolina, United States

Santee Hematology Oncology, Inc.

Sumter, South Carolina, United States

Center for Biomedical Research

Knoxville, Tennessee, United States

Sarah Cannon Research Institution

Nashville, Tennessee, United States

Countries

United States

References

Yardley DA, Weaver R, Melisko ME, Saleh MN, Arena FP, Forero A, Cigler T, Stopeck A, Citrin D, Oliff I, Bechhold R, Loutfi R, Garcia AA, Cruickshank S, Crowley E, Green J, Hawthorne T, Yellin MJ, Davis TA, Vahdat LT. EMERGE: A Randomized Phase II Study of the Antibody-Drug Conjugate Glembatumumab Vedotin in Advanced Glycoprotein NMB-Expressing Breast Cancer. J Clin Oncol. 2015 May 10;33(14):1609-19. doi: 10.1200/JCO.2014.56.2959. Epub 2015 Apr 6.

Reference Type: BACKGROUND

PMID: 25847941 (View on PubMed)

Other Identifiers

CDX011-03

Identifier Type: -

Identifier Source: org_study_id