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

NCT ID: NCT05136677

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2025-11-12

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.

Detailed Description

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Conditions

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Mesothelioma, Malignant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Arm B

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Ipilimumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Pemetrexed

Specified dose on specified days

Intervention Type DRUG

Cisplatin

Specified dose on specified days

Intervention Type DRUG

Carboplatin

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-936558 Opdivo BMS-734016 Yervoy

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0009

Beijing, Beijing Municipality, China

Site Status

Local Institution - 0013

Harbin, Heilongjiang, China

Site Status

Local Institution - 0006

Zhengzhou, Henan, China

Site Status

Local Institution - 0005

Changsha, Hunan, China

Site Status

Local Institution - 0023

Wuhan, Hunan, China

Site Status

Local Institution - 0015

Yangzhou, Jiangsu, China

Site Status

Local Institution - 0003

Changchun, Jilin, China

Site Status

Local Institution - 0004

Shenyang, Liaoning, China

Site Status

Local Institution - 0021

Shenyang, Liaoning, China

Site Status

Local Institution - 0037

Jinan, Shandong, China

Site Status

Local Institution - 0030

Qingdao, Shandong, China

Site Status

Local Institution - 0001

Shanghai, Shanghai Municipality, China

Site Status

Local Institution - 0033

Taiyuan, Shanxi, China

Site Status

Local Institution - 0029

Chengdu, Sichuan, China

Site Status

Local Institution - 0007

Tianjin, Tianjin Municipality, China

Site Status

Local Institution - 0018

Tianjin, Tianjin Municipality, China

Site Status

Local Institution - 0010

Kunming, Yunnan, China

Site Status

Local Institution - 0014

Hangzhou, Zhejiang, China

Site Status

Local Institution - 0020

Hangzhou, Zhejiang, China

Site Status

Local Institution - 0012

Ningbo, Zhejiang, China

Site Status

Local Institution - 0016

Ningbo, Zhejiang, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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U1111-1265-3913

Identifier Type: OTHER

Identifier Source: secondary_id

CA209-6DW

Identifier Type: -

Identifier Source: org_study_id

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