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Completed

NCT Number: NCT03195478

A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors

The purpose of this study is to evaluate the safety and effectiveness of Nivolumab in combination with Ipilimumab in Chinese participants with previously treated late stage cancer.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0001, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mainland Chinese participants with advanced or recurrent solid tumors
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • One prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy

Exclusion criteria

  • Cancer that has spread to the brain or central nervous system unless it has been adequately treated . In addition, either no longer receiving corticosteroids, or on a stable or decreasing dose of no more than 10 mg daily prednisone (or equivalent)
  • Active, known or suspected autoimmune disease or infection
  • Positive blood screen for chronic infection of hepatitis B or hepatitis C (HCV antibody positive unless HCV RNA is negative)
  • Prior immuno-oncology therapy

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Nivolumab

Drug

Specified dose on specified days

Other names: BMS-936558, Opdivo

Ipilimumab

Drug

Specified dose on specified days

Other names: BMS-734016, Yervoy

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) in Part 1.

    Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

    Number of participants with Adverse events

  2. Number of Participants With Serious Adverse Events (SAEs) in Part 1.

    Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

    Number of participants with Adverse events

  3. Number of Participants With Adverse Events Leading to Discontinuation in Part 1.

    Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

    Number of participants with Adverse events

  4. Number of Participants With Adverse Events Leading to Death in Part 1.

    Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

    Number of participants with Adverse Events leading to death.

  5. Number of Participants With Clinical Laboratory Abnormalities in Part 1.

    Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

    Number of participants with clinical laboratory abnormalities.

  6. BICR-Assessed ORR in Part 2

    Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by BICR. (Approximately on average 3.21 Months)

    ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by BICR, according to RECIST v1.1 criteria, divided by the number of treated subjects.

    The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).

Secondary outcomes

  1. Cmax - Maximum Observed Serum Concentration in Part 1.

    Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    Cmax - Maximum observed serum concentration in Part 1.

  2. Tmax - Time of Maximum Observed Serum Concentration in Part 1.

    Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    Tmax - Time of maximum observed serum concentration in Part 1.

  3. AUC(0-T) - Area Under the Plasma Concentration-time Curve in Part 1.

    Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    AUC(0-T) - Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration. in Part 1.

  4. AUC(TAU) - Area Under the Concentration-time Curve in One Dosing Interval in Part 1.

    Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    AUC(TAU) - Area under the concentration-time curve in one dosing interval in Part 1.

  5. Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion in Part 1.

    Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    Ceoinf - Serum concentration achieved at the end of study drug infusion in Part 1.

  6. Ctau - Concentration at the End of Dosing Interval in Part 1.

    Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    Ctau - Concentration at the end of dosing interval in Part 1. The Ctau is equivilant to the CTrough at these time points.

  7. CLT - Total Body Clearance in Part 1.

    Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    CLT - Total body clearance in Part 1.

  8. Css-avg - Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) in Part 1.

    Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    Css-avg - Average concentration over a dosing interval (AUC(TAU)/tau) in Part 1.

  9. AI - Accumulation Index in Part 1.

    Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    AI - Accumulation index; ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC (TAU) in Part 1.

    Here SS = Steady State Here FD = First Dose

  10. T-HALFeff - Effective Elimination Half-life in Part 1.

    Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

    T-HALFeff - Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC(TAU), Cmax, or Ctau) in Part 1.

  11. Number of Participants With Nivolumab Anti Drug Antibodies in Part 1.

    Time frame: At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)

    Number of participants with nivolumab Anti Drug Antibodies in Part 1.

  12. Number of Participants With Ipilimumab Anti Drug Antibodies in Part 1.

    Time frame: At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)

    Number of participants with Ipilimumab Anti Drug Antibodies in Part 1.

  13. Investigator-Assessed ORR in Part 2

    Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by the Investigator. (Approximately on average 2 Months)

    ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated subjects.

    The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).

  14. Investigator-Assessed Disease Control Rate (DCR) in Part 2

    Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 as assessed by the Investigator. (Approximately on average 5 Months)

    The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per investigator.

  15. BICR-Assessed Disease Control Rate (DCR) in Part 2

    Time frame: Approximately 5.92 Months

    The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per BICR.

  16. BICR-Assessed Duration of Response (DOR) in Part 2

    Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

    The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.

  17. Investigator-Assessed Duration of Response (DOR) in Part 2

    Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

    The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.

  18. BICR-Assessed Progression Free Survival (PFS) in Part 2

    Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

    The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.

  19. Investigator-Assessed Progression Free Survival (PFS) in Part 2

    Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

    The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2 Study of Nivolumab (BMS-936558) in Combination With Ipilimumab (BMS-734016) in Chinese Participants With Previously Treated Metastatic or Recurrent Solid Tumors

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2017
Registry last updated
Sep 15, 2025

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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