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NCT Number: NCT01435369

Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in 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.

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Key information

Conditions

Melanoma Malignant Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hadassah Medical Center, Jerusalem, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Safety of CT-011

    Time frame: Approximately 28 months

    Safety will be assessed for incidence of Adverse Events

  2. Progression Free Survival by Immune Related Response Criteria

    Time frame: Approximately 28 months

  3. Overall Survival

    Time frame: Approximately 28 months

Sponsors and collaborators

Lead sponsor

Medivation, Inc.

Industry

Registry information

Official study title

Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2011
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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