Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CureTech Ltd
ClinicalTrials.gov Identifier:
NCT01435369
First received: September 8, 2011
Last updated: September 11, 2014
Last verified: September 2013
  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 ]

Enrollment: 103
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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:

  1. Participants must have a histologically or cytologically documented diagnosis of metastatic melanoma.
  2. Participants age is 18 years or older.
  3. Stage IV disease that is clearly progressive since last therapy
  4. ECOG performance status of 0 or 1.

Exclusion Criteria:

  1. Patients with uveal melanoma.
  2. 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.
  3. Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
  4. More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments.
  5. Women of child bearing potential who are pregnant

Note: This is only a partial list of eligibility criteria.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
The University of Chicago
Chicago, Illinois, United States, 60637
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
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: September 11, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014