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

Last updated on March 14, 2019

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Study Location
Yale University School of Medicine, Section of Med Onc.
New Haven, Connecticut, 06520 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma, Malignant Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT01435369
Pfizer
Completed
Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma

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