Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsor:
CureTech Ltd
Information provided by (Responsible Party):
CureTech Ltd
ClinicalTrials.gov Identifier:
NCT01435369
First received: September 8, 2011
Last updated: April 9, 2013
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Malignant Melanoma |
Drug: CT-011 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma |
Resource links provided by NLM:
Further study details as provided by CureTech Ltd:
Primary Outcome Measures:
- The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011 [ Time Frame: Approximately 28 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of CT-011 [ Time Frame: Approximately 28 months ] [ Designated as safety issue: Yes ]Safety will be assessed for incidence of Adverse Events
- Progression Free Survival by Immune Related Response Criteria [ Time Frame: Approximately 28 months ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Approximately 28 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: CT-011 at dose level 1 (1.5 mg/kg). |
Drug: CT-011
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.
|
| Active Comparator: CT-011 at dose level 2 (6 mg/kg). |
Drug: CT-011
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants must have a histologically or cytologically documented diagnosis of metastatic melanoma.
- Participants age is 18 years or older.
- Stage IV disease that is clearly progressive since last therapy
- ECOG performance status of 0 or 1.
Exclusion Criteria:
- Patients with uveal melanoma.
- Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with NSAIDs.
- Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
- More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments.
- Women of child bearing potential who are pregnant
Note: This is only a partial list of eligibility criteria.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435369
Locations
| United States, Connecticut | |
| Yale University School of Medicine, Section of Med Onc. | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Moffitt Cancer Center Cutaneous Oncology Department | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| Mass General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon,, New Hampshire, United States, 03756 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Ruttenberg Cancer Clinic - The Mount Sinai Hospital | |
| New York, New York, United States, 10029 | |
| United States, Oregon | |
| Providence Cancer Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15219-2739 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Baylor Univesity Medical Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Virginia | |
| University of Virginia Health System / Human Immune Therapy Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Israel | |
| Hadassah Medical Center | |
| Jerusalem, Israel | |
| Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
Sponsors and Collaborators
CureTech Ltd
Investigators
| Principal Investigator: | Michael B. Atkins, M.D. | Beth Israel Deaconess Cancer Center |
More Information
No publications provided
| Responsible Party: | CureTech Ltd |
| ClinicalTrials.gov Identifier: | NCT01435369 History of Changes |
| Other Study ID Numbers: | CT-2011-01, 2011-004501-24 |
| Study First Received: | September 8, 2011 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013