Breast CancerPhase 2EMERGENCT01156753
A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
A Phase 2 study testing CDX-011 and "Investigator's Choice" chemotherapy in people with Breast Cancer, run by Celldex Therapeutics at 24 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CDX-011 and "Investigator's Choice" chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 24 sitesUnited States
- Study dates
- Jul 2010to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Among other criteria, patients must meet all of the following conditions to be eligible for the study:
- 18 years of age or older.
- Locally advanced or metastatic breast cancer.
- Previous treatment with at least two but no more than seven prior chemotherapy treatments for progressive, recurrent or metastatic breast cancer.
- 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.)
- 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.
Who cannot join
- Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
- Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
- Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Peachtree Hematology-Oncology Consultants PC
Atlanta, Georgia, 30318
Georgia Cancer Specialists
Atlanta, Georgia, 30341
The University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294
Levine Cancer Institute/Blumenthal Cancer Center
Charlotte, North Carolina, 28203
Oncology Hematology Care
Cincinnati, Ohio, 45242
South Carolina Oncology Associates
Columbia, South Carolina, 29210
Henry Ford Health System
Detroit, Michigan, 48202
Center for Biomedical Research
Knoxville, Tennessee, 37909
Clinical Research Alliance Inc.
Lake Success, New York, 11042
Breastlink Medical Group
Long Beach, California, 90806
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Montana Cancer Institute Foundation
Missoula, Montana, 59802
Sarah Cannon Research Institution
Nashville, Tennessee, 37203
Cancer Care of Louisiana
New Orleans, Louisiana, 70115
Weill Cornell Breast Center/Weill Cornell Medical College
New York, New York, 10065
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Guthrie Clinic, Ltd.
Sayre, Pennsylvania, 18840
Orchard Healthcare Research Inc.
Skokie, Illinois, 60076
Santee Hematology Oncology, Inc.
Sumter, South Carolina, 29150
Montefiore-Einstein Cancer Center
The Bronx, New York, 10467
Arizona Cancer Center
Tucson, Arizona, 85724
Florida Cancer Specialists
West Coast, Florida
Cancer Treatment Centers of America at Midwestern Regional Medical Center
Zion, Illinois, 60099
About this study
Official title: A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
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.
Read the 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
- Being tested
- CDX-011, "Investigator's Choice" chemotherapy
- Keywords
- CR011-vcMMAE, locally advanced breast cancer, metastatic breast cancer, breast cancer, CDX-011, GPNMB, Targeted treatment for breast cancer, Locally advanced or metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-011Drug
CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle.
"Investigator's Choice" chemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CDX-011 | Experimental | Not described Receives: Drug: CDX-011 |
| "Investigator's Choice" chemotherapy | Active comparator | Not described Receives: Drug: "Investigator's Choice" chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
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.
Measured: 6 or more weeks following treatment initiation
Secondary outcomes (2)
Progression-free survival
Progression-free survival is defined as the time from randomization to the earlier of disease progression or death due to any cause.
Measured: At least 18 months following treatment initiation
Adverse Events
The number and percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156753
- Sponsor's protocol ID
- CDX011-03
- Acronym
- EMERGE
- Status last verified
- Jun 2017
- First submitted
- 30 Jun 2010
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25847941
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
- ClinicalTrials.gov ID
- NCT01156753
- Acronym / sponsor ID
- EMERGE / CDX011-03
- Conditions
- Breast Cancer
- Keywords
- CR011-vcMMAE, locally advanced breast cancer, metastatic breast cancer, breast cancer, CDX-011, GPNMB, Targeted treatment for breast cancer, Locally advanced or metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDX-011 | Experimental | Drug: CDX-011 |
| "Investigator's Choice" chemotherapy | Active comparator | Drug: "Investigator's Choice" chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Among other criteria, patients must meet all of the following conditions to be eligible for the study:
- 18 years of age or older.
- Locally advanced or metastatic breast cancer.
- Previous treatment with at least two but no more than seven prior chemotherapy treatments for progressive, recurrent or metastatic breast cancer.
- 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.)
Key exclusion criteria (4 listed)
- Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
- Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
- Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDX-011CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle. | Drug | CDX-011 |
| "Investigator's Choice" chemotherapyAny 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. | Drug | "Investigator's Choice" chemotherapy |
Primary outcome
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.
2 secondary outcomes
Progression-free survival
Time frame: At least 18 months following treatment initiation
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 25847941Yardley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDX-011 and "Investigator's Choice" chemotherapy in people with Breast Cancer, run by Celldex Therapeutics at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 or more weeks following treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01156753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.