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Phase 1 Biomarker Study of Anti-PD-1 in Advanced Melanoma

Complete title: An Exploratory Study of the Biologic Effects of BMS-936558 (Anti-PD-1 Monoclonal Antibody) Treatment in Subjects with Advanced Melanoma (Unresectable or Metastatic)

Research Study Number       20122036
    
Principal Investigator       Shailender Bhatia, MD
    
Phase       I

Look up trial at NIH

Research Study Description

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936558 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced).

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Men and women > 18 years

- Eastern Cooperative Oncology Group (ECOG) status = 0 to 1

- Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma

- Subject must have histologic or cytologic confirmation of advanced melanoma

- Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

- Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Men and women > 18 years

- Eastern Cooperative Oncology Group (ECOG) status = 0 to 1

- Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma

- Subject must have histologic or cytologic confirmation of advanced melanoma

- Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

- Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies

Other exclusion criteria may apply.



Research Study Number       20122036
    
Contact       Mariane Estofalete
    
Telephone       206/288-7219
    
   

Keywords
Melanoma; Solid Tumors

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