Overview

This trial is active, not recruiting.

Condition renal cell carcinoma
Treatments bms-936558
Phase phase 2
Targets CD27, PD-1
Sponsor Bristol-Myers Squibb
Collaborator Ono Pharma USA Inc
Start date May 2011
End date May 2013
Trial size 150 participants
Trial identifier NCT01354431, CA209-010

Summary

The purpose of this study is to measure how active BMS-936558 is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
bms-936558 BMS-936558
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
(Experimental)
bms-936558 BMS-936558
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
(Experimental)
bms-936558 BMS-936558
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

Primary Outcomes

Measure
Progression free survival as measured by tumor assessments (radiographic scans) and the collection of death data. It will be compared to the doses given across the 3 treatment arms to see if a dose response exists.
time frame: Tumor assessments (radiographic scans) will be done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression is documented. Subjects will be assessed for survival every 3 months.

Secondary Outcomes

Measure
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
The overall survival in the BMS-936558 arms as collected by death data
time frame: The survival in each treatment arm will be assessed by the collection of death data every 3 months following the discontinuation of study therapy until a subjects death

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: - Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component - Previous treatment with at least one anti-angiogenic agent - Progressed within 6 months of study enrollment - Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease - Must have available tumor tissue for submission - Subjects must also meet various laboratory parameters for inclusion Exclusion Criteria: - Subjects with any active autoimmune disease or a history of known autoimmune disease

Additional Information

Official title A Randomized, Blinded, Phase 2 Dose-Ranging Study Of BMS-936558 (MDX-1106) In Subjects With Progressive, Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.