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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004501-24 | EudraCT Number |
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The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells.
All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug:
Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).
Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).
Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-011 at dose level 1 (1.5 mg/kg). | Active Comparator |
| |
| CT-011 at dose level 2 (6 mg/kg). | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-011 | Drug | The monoclonal antibody, CT-011 is administered intravenously at 2 dosage levels, 1.5mg/kg and 6.0 mg/kg to patients with metastatic melanoma. The study drug will be given every other week for a total of up to 27 study drug infusions for about 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011 | Approximately 28 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of CT-011 | Safety will be assessed for incidence of Adverse Events | Approximately 28 months |
| Progression Free Survival by Immune Related Response Criteria | Approximately 28 months |
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Inclusion Criteria:
Exclusion Criteria:
Note: This is only a partial list of eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Michael B. Atkins, M.D. | Beth Israel Deaconess Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine, Section of Med Onc. | New Haven | Connecticut | 06520 | United States | ||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 23, 2016 | |
| Unrelease | Yes | |
| Release | Sep 26, 2016 |
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| Overall Survival | Approximately 28 months |
| Moffitt Cancer Center Cutaneous Oncology Department |
| Tampa |
| Florida |
| 33612 |
| United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Ruttenberg Cancer Clinic - The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Providence Cancer Center | Portland | Oregon | 97213 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219-2739 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor Univesity Medical Center | Dallas | Texas | 75246 | United States |
| University of Virginia Health System / Human Immune Therapy Center | Charlottesville | Virginia | 22908 | United States |
| Hadassah Medical Center | Jerusalem | Israel |
| Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Reset | Nov 14, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 23, 2016 | Yes | |||
| Sep 26, 2016 | Nov 14, 2016 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C585832 | pidilizumab |
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