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

NCT01435369 | Completed Phase 2 DMC

• 2 other identifiers: CT-2011-012011-004501-24
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 18

Brief Summary

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.

Conditions

Melanoma; Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011

  Approximately 28 months

Secondary Outcomes (3)

• Safety of CT-011

  Approximately 28 months

• Progression Free Survival by Immune Related Response Criteria

  Approximately 28 months

• Overall Survival

  Approximately 28 months

Study Arms (2)

CT-011 at dose level 1 (1.5 mg/kg).

ACTIVE COMPARATOR

Drug: CT-011

CT-011 at dose level 2 (6 mg/kg).

ACTIVE COMPARATOR

Drug: CT-011

Interventions

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.

CT-011 at dose level 1 (1.5 mg/kg).; CT-011 at dose level 2 (6 mg/kg).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medivation, Inc.: lead

Study Sites (18)

Yale University School of Medicine, Section of Med Onc.

New Haven, Connecticut, 06520, United States

Location

Moffitt Cancer Center Cutaneous Oncology Department

Tampa, Florida, 33612, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Ruttenberg Cancer Clinic - The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Providence Cancer Center

Portland, Oregon, 97213, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219-2739, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Univesity Medical Center

Dallas, Texas, 75246, United States

Location

University of Virginia Health System / Human Immune Therapy Center

Charlottesville, Virginia, 22908, United States

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Melanoma

Interventions

pidilizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael B. Atkins, M.D.

  Beth Israel Deaconess Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 16, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 21, 2016

Record last verified: 2015-12

Locations

US (16); IL (2)