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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
N/A
Open (Enrolling)
Both
Melanoma, Malignant Melanoma

Thank you

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:

Interventional

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:

No

Principal Investigator

Michael B. Atkins, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CT-2011-01

NCT ID:

NCT01435369

Start Date:

November 2011

Completion Date:

May 2014

Related Keywords:

  • Melanoma
  • Malignant Melanoma
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Northwestern Memorial HospitalChicago, Illinois  60611
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
The University of ChicagoChicago, Illinois  60637
Mass General HospitalBoston, Massachusetts  02114
Providence Cancer CenterPortland, Oregon  97213-2933
Yale University School of Medicine, Section of Med Onc.New Haven, Connecticut  06520
Moffitt Cancer Center Cutaneous Oncology DepartmentTampa, Florida  33612
Ruttenberg Cancer Clinic - The Mount Sinai HospitalNew York, New York  10029
Baylor Univesity Medical CenterDallas, Texas  75246
University of Virginia Health System / Human Immune Therapy CenterCharlottesville, Virginia  22908