A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors
A Phase 1 Study for Safety and Tolerability of BMS-986205 Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
1 other identifier
interventional
11
1 country
1
Brief Summary
The purpose of this study is to assess the safety and tolerability for the combination therapy of BMS-986205 and Nivolumab in patients with advanced tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedStudy Start
First participant enrolled
June 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2018
CompletedApril 1, 2019
March 1, 2019
1.5 years
June 14, 2017
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
Incidence of Adverse Events (AEs)
Safety and Tolerability
15 months
Incidence of Serious Adverse Events (SAEs)
Safety and Tolerability
15 months
Incidence of Death
Safety and Tolerability
15 months
Incidence of Laboratory Abnormalities
Safety and Tolerability
15 months
AEs leading to discontinuation
Safety and Tolerability
Up to one year
Secondary Outcomes (11)
Maximum observed plasma concentration (Cmax)
Up to one year
Time of maximum observed plasma concentration (Tmax)
Up to one year
Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)]
Up to one year
Trough observed plasma concentration at the end of the dosing interval (Ctrough)
Up to one year
Apparent total body clearance (CLT/F)
Up to one year
- +6 more secondary outcomes
Study Arms (1)
Dose Escalation
EXPERIMENTALmonotherapy and combination therapy
Interventions
Eligibility Criteria
You may qualify if:
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Participants must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per Response Evaluation Criteria In Solid Tumors (RECIST v1.1)
- Participants must have received, and then progressed or been intolerant to standard treatment regimen in the advanced or metastatic setting
- Eastern Cooperative Oncology Group performance status of ≤ 1
You may not qualify if:
- Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded
- History of congenital or autoimmune hemolytic disorders
- History or presence of hypersensitivity or idiosyncratic reaction to methylene blue
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Chuo-ku, Tokyo, 1040045, Japan
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 20, 2017
Study Start
June 23, 2017
Primary Completion
December 11, 2018
Study Completion
December 11, 2018
Last Updated
April 1, 2019
Record last verified: 2019-03