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Completed

NCT Number: NCT03192943

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

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Key information

Conditions

Advanced Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Chuo-ku, Tokyo, 1040045, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986205

Drug

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified day

Other names: Opdivo, BMS-936558

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2017
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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