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

• Sponsor: Medivation, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01435369
• Collaborator: (none)
• Enrollment: 103
• Locations: 18
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma; Malignant Melanoma	Drug: CT-011	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Safety of CT-011 [Approximately 28 months]

   Safety will be assessed for incidence of Adverse Events

2. Progression Free Survival by Immune Related Response Criteria [Approximately 28 months]

3. Overall Survival [Approximately 28 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine, Section of Med Onc.	New Haven	Connecticut	United States	06520
2	Moffitt Cancer Center Cutaneous Oncology Department	Tampa	Florida	United States	33612
3	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
4	The University of Chicago	Chicago	Illinois	United States	60637
5	Mass General Hospital	Boston	Massachusetts	United States	02114
6	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
7	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
8	Dartmouth Hitchcock Medical Center	Lebanon,	New Hampshire	United States	03756
9	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10021
10	Ruttenberg Cancer Clinic - The Mount Sinai Hospital	New York	New York	United States	10029
11	Providence Cancer Center	Portland	Oregon	United States	97213
12	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
13	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15219-2739
14	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
15	Baylor Univesity Medical Center	Dallas	Texas	United States	75246
16	University of Virginia Health System / Human Immune Therapy Center	Charlottesville	Virginia	United States	22908
17	Hadassah Medical Center	Jerusalem		Israel
18	Chaim Sheba Medical Center	Tel Hashomer		Israel	52621

Sponsors and Collaborators

• Medivation, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medivation, Inc.
• ClinicalTrials.gov Identifier: NCT01435369
• Other Study ID Numbers: CT-2011-01; 2011-004501-24
• First Posted: Sep 16, 2011
• Last Update Posted: Jan 21, 2016
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Melanoma; Pidilizumab

Study Results

No Results Posted as of Jan 21, 2016