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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivo/Ipi Combination Therapy A<br> | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|
| Experimental: Nivo/Ipi Combination Therapy B<br> | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|
| Experimental: Nivo/Ipi Combination Therapy C<br> | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|
| Experimental: Nivo/Ipi Combination Arm D<br> | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Number and percent of all treated participants that experience Adverse Events (AEs) | Measured by number of patients Applies to Part 1 | Up to 3.2 years | 
| Composite of Number and percent of all treated participants that experience serious adverse events (SAEs) | Measured by number of patients Applies to Part 1 | Up to 3.2 years | 
| Composite of Number and percent of all treated participants that experience AEs leading to discontinuation | Measured by number of patients Applies to Part 1 | Up to 3.2 years | 
| Composite of Number and percent of all treated subjects that experience AEs leading to death | Measured by number of patients Applies to Part 1 | Up to 3.2 years | 
| Composite of Number and percent of participants with clinical laboratory abnormalities | Measured by number of patients Applies to Part 1 | Up to 3.2 years | 
| Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR) | Applies to Part 2 | Up to 3.2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) | Applies to Part 1 | Up to 3.2 years | 
| Time of maximum observed serum concentration (Tmax) | Applies to Part 1 | Up to 3.2 years | 
| Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration (AUC[0-T]) | Applies to Part 1 | Up to 3.2 years | 
| Incidence of anti-drug antibodies (ADA) | Applies to Part 1 | Up to 3.2 years | 
| ORR by RECIST 1.1 by Investigator | Applies to Part 2 | Up to 3.2 years | 
| Disease Control Rate (DCR) by RECIST 1.1 by BICR | Applies to Part 2 | Up to 3.2 years | 
| DCR by RECIST 1.1 by Investigator | Applies to Part 2 | Up to 3.2 years | 
| Duration of Response (DoR) by RECIST 1.1 by BICR | Applies to Part 2 | Up to 3.2 years | 
| DoR by RECIST 1.1 by Investigator | Applies to Part 2 | Up to 3.2 years | 
| Progression-Free Survival (PFS) by RECIST 1.1 by BICR | Applies to Part 2 | Up to 3.2 years | 
| PFS by RECIST 1.1 by Investigator | Applies to Part 2 | Up to 3.2 years |