Phase I Biomarker Study (BMS-936558)

• Status: Completed
• Trial end date: 2019-05-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharma USA Inc
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Women and men ≥ 18 years of age.

• Histologic confirmation of renal cell carcinoma with a clear cell component.

• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

• Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.

• Previously treated subjects must have failed at least 1 prior anti-angiogenic agent and can have a maximum of 3 prior systemic treatments for renal cell cancer.

• Subjects in the treatment naive arm cannot have received prior systemic therapy for their renal cell carcinoma.

Exclusion Criteria:

• Active or progressing brain metastases.

• Active concomitant.

• Active or history of autoimmune disease.

• Active use of systemic corticosteroids.

• Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.