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

Phase 2
18 Years
Open (Enrolling)
Melanoma, Malignant Melanoma

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Approximately 28 months

Safety Issue:


Principal Investigator

Michael B. Atkins, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

May 2014

Related Keywords:

  • Melanoma
  • Malignant Melanoma
  • Melanoma



Memorial Sloan Kettering Cancer Center New York, New York  10021
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Northwestern Memorial Hospital Chicago, Illinois  60611
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
University of Pennsylvania Philadelphia, Pennsylvania  19104
Dana Farber Cancer Institute Boston, Massachusetts  02115
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
The University of Chicago Chicago, Illinois  60637
Mass General Hospital Boston, Massachusetts  02114
Providence Cancer Center Portland, Oregon  97213-2933
Yale University School of Medicine, Section of Med Onc. New Haven, Connecticut  06520
Moffitt Cancer Center Cutaneous Oncology Department Tampa, Florida  33612
Ruttenberg Cancer Clinic - The Mount Sinai Hospital New York, New York  10029
Baylor Univesity Medical Center Dallas, Texas  75246
University of Virginia Health System / Human Immune Therapy Center Charlottesville, Virginia  22908