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 30, 2013
Last verified: September 2013

September 8, 2011
September 30, 2013
November 2011
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01435369 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Melanoma
  • Malignant Melanoma
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 1 (1.5 mg/kg).
    Intervention: Drug: CT-011
  • Active Comparator: CT-011 at dose level 2 (6 mg/kg).
    Intervention: Drug: CT-011
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
August 2013
August 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT01435369
CT-2011-01, 2011-004501-24
Yes
CureTech Ltd
CureTech Ltd
Not Provided
Principal Investigator: Michael B. Atkins, M.D. Beth Israel Deaconess Cancer Center
CureTech Ltd
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP