Overview

This trial is active, not recruiting.

Condition renal cell carcinoma
Treatments bms-936558 (anti-pd-1)
Phase phase 1
Sponsor Bristol-Myers Squibb
Collaborator Ono Pharma USA Inc
Start date August 2011
End date December 2014
Trial size 80 participants
Trial identifier NCT01358721, 2011-005379-18, CA209-009

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
bms-936558 (anti-pd-1)
Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response
(Experimental)
bms-936558 (anti-pd-1)
Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response
(Experimental)
bms-936558 (anti-pd-1)
Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response
(Experimental)
(treatment naive)
bms-936558 (anti-pd-1)
Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response

Primary Outcomes

Measure
Immunomodulatory activity as measured by the functional and phenotypic characterization of peripheral immune cells, modulation/changes in soluble factors, and the characterization of tumor immune infiltrates and the expression of tumor markers
time frame: Biomarker samples will be collected prior to the first study treatment through up to 24 weeks following initiation of study treatment

Secondary Outcomes

Measure
Safety and tolerability of BMS-936558 as measured by the incidence and severity of adverse events
time frame: Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (at progression of disease, toxicities requiring discontinuation, withdrawal of consent or study closure)
Progression free survival in the BMS-936558 arms
time frame: Progression free survival will be assessed in each individual treatment arm by tumor assessments every 6 weeks
The tumor response rate in the BMS-936558 arms as assessed by the Investigator assessment of best overall response
time frame: Up to 22 months after study start
Overall response rate for BMS-936558 as assessed by the number of subjects which demonstrate an objective response divided by the total number of treated subjects with measurable disease at baseline
time frame: response rate will be assessed by tumor assessments every 6 weeks
Disease control rate for BMS-936558 as measured by the number of subjects with an objective response + the number of subjects with stable disease divided by the total number of treated subjects with measurable disease at baseline
time frame: disease control will be assessed by tumor assessments every 6 weeks
Duration of objective response for BMS-936558 as measured by the time when the criteria for an objective response are first met until the date of documented disease progression or death
time frame: Duration of response will be assessed by tumor assessments every 6 weeks
Duration of stable disease for BMS-936558 as measured in subjects whose best overall response is stable disease as the time from baseline until the date of documented disease progression or death
time frame: Duration of response will be assessed by tumor assessments every 6 weeks
Immunogenicity of BMS-936558 as measured by the detection of human antibodies against BMS-936558
time frame: Serum sample collected at baseline, 12 weeks following initiation of study treatment; and during the first 2 follow-up visits in the follow-up phase

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
Description Intervention Model: Parallel Dose Comparison
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.