Phase I Biomarker Study (BMS-936558)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Drug: BMS-936558 (Anti-PD-1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358721

2011-005379-18 (EudraCT Number)

CA209-009

Details and patient eligibility

About

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

Full description

Intervention Model: Parallel Dose Comparison

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 4 patient groups

Arm 1: BMS-936558

Experimental group

Treatment:

Drug: BMS-936558 (Anti-PD-1)

Drug: BMS-936558 (Anti-PD-1)

Drug: BMS-936558 (Anti-PD-1)

Arm 2: BMS-936558

Experimental group

Treatment:

Drug: BMS-936558 (Anti-PD-1)

Drug: BMS-936558 (Anti-PD-1)

Drug: BMS-936558 (Anti-PD-1)

Arm 3: BMS-936558

Experimental group

Treatment:

Drug: BMS-936558 (Anti-PD-1)

Drug: BMS-936558 (Anti-PD-1)

Drug: BMS-936558 (Anti-PD-1)

Arm 4: BMS-936558

Experimental group

Description:

(treatment naive)

Treatment:

Drug: BMS-936558 (Anti-PD-1)

Drug: BMS-936558 (Anti-PD-1)

Drug: BMS-936558 (Anti-PD-1)