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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192943
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: BMS-986205 Biological: Nivolumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study for Safety and Tolerability of BMS-986205 Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
Actual Study Start Date : June 23, 2017
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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:
  • Opdivo
  • BMS-936558


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: 15 months ]
    Safety and Tolerability

  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: 15 months ]
    Safety and Tolerability

  3. Incidence of Death [ Time Frame: 15 months ]
    Safety and Tolerability

  4. Incidence of Laboratory Abnormalities [ Time Frame: 15 months ]
    Safety and Tolerability

  5. AEs leading to discontinuation [ Time Frame: Up to one year ]
    Safety and Tolerability


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to one year ]
    To characterize the Pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab

  2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to one year ]
    To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

  3. Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to one year ]
    To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

  4. Trough observed plasma concentration at the end of the dosing interval (Ctrough) [ Time Frame: Up to one year ]
    To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

  5. Apparent total body clearance (CLT/F) [ Time Frame: Up to one year ]
    To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

  6. Apparent volume of distribution at steady-state (Vss/F) [ Time Frame: Up to one year ]
    To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

  7. Percent urinary recovery over 24 hours (%UR24) [ Time Frame: Up to 24 hours ]
    To characterize the PK of BMS-986205 administered alone and in combination with nivolumab

  8. Biomarker Availability [ Time Frame: Up to one year ]
    To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab

  9. Incidence of anti-drug antibody (ADA) [ Time Frame: Up to one year ]
    To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205

  10. Best Overall Response (BOR) [ Time Frame: Up to one year ]
    To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors

  11. Duration of Response (DOR) [ Time Frame: Up to one year ]
    To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192943


Locations
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Japan
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03192943    
Other Study ID Numbers: CA017-048
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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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
Additional relevant MeSH terms:
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Nivolumab
Linrodostat
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors