Clinical trial NCT03192943: A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors
Official title: A Phase 1 Study for Safety and Tolerability of BMS-986205 Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: 15 months
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: 15 months
measure: Incidence of Death
timeFrame: 15 months
measure: Incidence of Laboratory Abnormalities
timeFrame: 15 months
measure: AEs leading to discontinuation
timeFrame: Up to one year
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to one year
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to one year
measure: Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)]
timeFrame: Up to one year
measure: Trough observed plasma concentration at the end of the dosing interval (Ctrough)
timeFrame: Up to one year
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to one year
measure: Apparent volume of distribution at steady-state (Vss/F)
timeFrame: Up to one year
measure: Percent urinary recovery over 24 hours (%UR24)
timeFrame: Up to 24 hours
measure: Biomarker Availability
timeFrame: Up to one year
measure: Incidence of anti-drug antibody (ADA)
timeFrame: Up to one year
measure: Best Overall Response (BOR)
timeFrame: Up to one year
measure: Duration of Response (DOR)
timeFrame: Up to one year
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: