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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435369
• Other study ID #: CT-2011-01
• Secondary ID: 2011-004501-24
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2011
• Last updated: December 16, 2015
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2015
• Source: Medivation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem
Israel	Chaim Sheba Medical Center	Tel Hashomer
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Mass General Hospital	Boston	Massachusetts
United States	University of Virginia Health System / Human Immune Therapy Center	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	The University of Chicago	Chicago	Illinois
United States	Baylor Univesity Medical Center	Dallas	Texas
United States	Dartmouth Hitchcock Medical Center	Lebanon,	New Hampshire
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine, Section of Med Onc.	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Ruttenberg Cancer Clinic - The Mount Sinai Hospital	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Providence Cancer Center	Portland	Oregon
United States	Moffitt Cancer Center Cutaneous Oncology Department	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medivation, Inc.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011		Approximately 28 months
Secondary	Safety of CT-011	Safety will be assessed for incidence of Adverse Events	Approximately 28 months
Secondary	Progression Free Survival by Immune Related Response Criteria		Approximately 28 months
Secondary	Overall Survival		Approximately 28 months