A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors

Advanced Cancer Clinical Trial

Official title:

A Phase 1 Study for Safety and Tolerability of BMS-986205 Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192943
• Other study ID #: CA017-048
• Status: Completed
• Phase: Phase 1
• Start date: June 23, 2017
• Est. completion date: December 11, 2018

Study information

• Verified date: March 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• BMS-986205
Specified dose on specified days

Biological:
• Nivolumab
Specified dose on specified day

Locations

Country	Name	City	State
Japan	Local Institution	Chuo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	Safety and Tolerability	15 months
Primary	Incidence of Serious Adverse Events (SAEs)	Safety and Tolerability	15 months
Primary	Incidence of Death	Safety and Tolerability	15 months
Primary	Incidence of Laboratory Abnormalities	Safety and Tolerability	15 months
Primary	AEs leading to discontinuation	Safety and Tolerability	Up to one year
Secondary	Maximum observed plasma concentration (Cmax)	To characterize the Pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab	Up to one year
Secondary	Time of maximum observed plasma concentration (Tmax)	To characterize the PK of BMS-986205 administered alone and in combination with nivolumab	Up to one year
Secondary	Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)]	To characterize the PK of BMS-986205 administered alone and in combination with nivolumab	Up to one year
Secondary	Trough observed plasma concentration at the end of the dosing interval (Ctrough)	To characterize the PK of BMS-986205 administered alone and in combination with nivolumab	Up to one year
Secondary	Apparent total body clearance (CLT/F)	To characterize the PK of BMS-986205 administered alone and in combination with nivolumab	Up to one year
Secondary	Apparent volume of distribution at steady-state (Vss/F)	To characterize the PK of BMS-986205 administered alone and in combination with nivolumab	Up to one year
Secondary	Percent urinary recovery over 24 hours (%UR24)	To characterize the PK of BMS-986205 administered alone and in combination with nivolumab	Up to 24 hours
Secondary	Biomarker Availability	To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab	Up to one year
Secondary	Incidence of anti-drug antibody (ADA)	To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205	Up to one year
Secondary	Best Overall Response (BOR)	To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors	Up to one year
Secondary	Duration of Response (DOR)	To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors	Up to one year

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form