Clinical trial NCT01435369: Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
Official title: Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Malignant Melanoma
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-16
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011
timeFrame: Approximately 28 months
Secondary outcomes:
measure: Safety of CT-011
timeFrame: Approximately 28 months
measure: Progression Free Survival by Immune Related Response Criteria
timeFrame: Approximately 28 months
measure: Overall Survival
timeFrame: Approximately 28 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine, Section of Med Onc.
state: Connecticut
city: Tampa
country: United States
facility: Moffitt Cancer Center Cutaneous Oncology Department
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Lebanon,
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Ruttenberg Cancer Clinic - The Mount Sinai Hospital
state: New York
city: Portland
country: United States
facility: Providence Cancer Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Univesity Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System / Human Immune Therapy Center
state: Virginia
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Beth Israel Deaconess Cancer Center
name: Michael B. Atkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References: