Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma
Overview
- Phase
- Phase 2
- Intervention
- CT-011
- Conditions
- Melanoma
- Sponsor
- Medivation, Inc.
- Enrollment
- 103
- Locations
- 18
- Primary Endpoint
- The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
CT-011 at dose level 1 (1.5 mg/kg).
Intervention: CT-011
CT-011 at dose level 2 (6 mg/kg).
Intervention: CT-011
Outcomes
Primary Outcomes
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
- Safety of CT-011(Approximately 28 months)
- Progression Free Survival by Immune Related Response Criteria(Approximately 28 months)
- Overall Survival(Approximately 28 months)