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
Overview
- Phase
- Phase 1
- Intervention
- Nivolumab
- Conditions
- Solid Tumor
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 37
- Locations
- 11
- Primary Endpoint
- Number of Participants With Adverse Events (AEs) in Part 1.
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Nivo/Ipi Combination Therapy A
Intervention: Nivolumab
Nivo/Ipi Combination Therapy A
Intervention: Ipilimumab
Nivo/Ipi Combination Therapy B
Intervention: Nivolumab
Nivo/Ipi Combination Therapy B
Intervention: Ipilimumab
Nivo/Ipi Combination Therapy C
Intervention: Nivolumab
Nivo/Ipi Combination Therapy C
Intervention: Ipilimumab
Nivo/Ipi Combination Arm D
Intervention: Nivolumab
Nivo/Ipi Combination Arm D
Intervention: Ipilimumab
Outcomes
Primary Outcomes
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
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
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
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.
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.
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
- Cmax - Maximum Observed Serum Concentration in Part 1.(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.(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 in Part 1.(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.(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.(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.(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))
- CLT - Total Body Clearance in Part 1.(At Cycle 3 Day 1 for Arm A, 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.(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))
- AI - Accumulation Index in Part 1.(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 in Part 1.(At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days))
- Number of Participants With Nivolumab Anti Drug Antibodies in Part 1.(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.(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))
- Investigator-Assessed ORR in Part 2(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))
- BICR-Assessed Duration of Response (DOR) in Part 2(From first dose to 100 days post last dose (approximately 102 weeks))
- Investigator-Assessed Disease Control Rate (DCR) in Part 2(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))
- BICR-Assessed Disease Control Rate (DCR) in Part 2(Approximately 5.92 Months)
- BICR-Assessed Progression Free Survival (PFS) in Part 2(From first dose to 100 days post last dose (approximately 102 weeks))
- Investigator-Assessed Progression Free Survival (PFS) in Part 2(From first dose to 100 days post last dose (approximately 102 weeks))
- Investigator-Assessed Duration of Response (DOR) in Part 2(From first dose to 100 days post last dose (approximately 102 weeks))