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

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

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: BMS-986205; Biological: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1040045
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation; monotherapy and combination therapy	Drug: BMS-986205; Specified dose on specified days; Biological: Nivolumab; Specified dose on specified day; Other Names: BMS-936558; Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax)	To characterize the Pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab	Up to one year
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
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
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
Apparent total body clearance (CLT/F)	To characterize the PK of BMS-986205 administered alone and in combination with nivolumab	Up to one year
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
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
Biomarker Availability	To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab	Up to one year
Incidence of anti-drug antibody (ADA)	To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205	Up to one year
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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Actual): December 11, 2018
• Study Completion (Actual): December 11, 2018

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Linrodostat
• Other Study ID Numbers: CA017-048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes