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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Malignant Melanoma
• Intervention / Treatment: Drug: CT-011

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Tel Hashomer, Israel, 52621
    • Chaim Sheba Medical Center
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine, Section of Med Onc.
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center Cutaneous Oncology Department
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Mass General Hospital
  • New Hampshire
    • Lebanon,, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Ruttenberg Cancer Clinic - The Mount Sinai Hospital
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219-2739
      • University of Pittsburgh Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Univesity Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System / Human Immune Therapy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Overall Survival		Approximately 28 months

Collaborators and Investigators

• Sponsor: Medivation, Inc.
• Investigators: Principal Investigator: Michael B. Atkins, M.D., Beth Israel Deaconess Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 8, 2011
• First Submitted That Met QC Criteria: September 15, 2011
• First Posted (Estimate): September 16, 2011

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pidilizumab
• Other Study ID Numbers: CT-2011-01; 2011-004501-24 (EudraCT Number)