A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of the combination of nivolumab and ipilimumab in Chinese participants with malignant pleural mesothelioma.

Official Title
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A Phase II, Randomized, Open-label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First-line Therapy for Unresectable Pleural Mesothelioma in Chinese Participants

Conditions
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Mesothelioma, Malignant

Intervention / Treatment
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* Biological: Nivolumab
* Biological: Ipilimumab
* Drug: Pemetrexed
* Drug: Cisplatin
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven diagnosis of Malignant Pleural Mesothelioma (MPM) with determination of epithelioid vs non-epithelioid histology Must have advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy) Available tumor samples for centralized testing Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Measurable disease Exclusion Criteria: Primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy Prior therapy for MPM (including chemotherapy, radical pleuropneumonectomy and non-palliative radiotherapy) 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|
| Experimental: Arm B<br> | Drug: Pemetrexed<br>* Specified dose on specified days<br>Drug: Cisplatin<br>* Specified dose on specified days<br>Drug: Carboplatin<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 58 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator |  | Up to 58 months | 
| Progression Free Survival (PFS) by m-RECIST by Investigator |  | Up to 58 months | 
| Incidence of Adverse Events (AEs) |  | Up to 58 months | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 58 months | 
| Incidence of immune-related AEs |  | Up to 58 months | 
| Incidence of deaths |  | Up to 58 months | 
| Incidence of participants with laboratory abnormalities |  | Up to 58 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant Pleural Mesothelioma (MPM), Nivolumab, Ipilimumab