A Phase 2 interventional study of CDX-011 and "Investigator's Choice" chemotherapy in Breast Cancer, sponsored by Celldex Therapeutics. Completed at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Celldex Therapeutics · Phase 2, Interventional, and Treatment
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Celldex Therapeutics is the lead sponsor of 45 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.
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Among other criteria, patients must meet all of the following conditions to be eligible for the study:
Exclusion Criteria:
Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
Drug: CDX-011
Drug: "Investigator's Choice" chemotherapy
CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle.
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.
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.
Time frame: 6 or more weeks following treatment initiation
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.
Time frame: 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.
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 record gives a start of Jul 2010, a primary completion of Oct 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glembatumumab vedotin