Evaluating nivolumab and ipilimumab for treating advanced malignant pleural mesothelioma in Chinese patients
Official title: 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
Run by Bristol-Myers Squibb · NCT05136677 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a combination of nivolumab and ipilimumab can help people with advanced malignant pleural mesothelioma feel better and live longer compared to standard chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | chemotherapy, nivolumab, ipilimumab |
| Locations | 26 sites (Beijing, Beijing and 25 other locations) |
| Trial ID | NCT05136677 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Chinese patients with histologically confirmed malignant pleural mesothelioma who have unresectable disease and an ECOG performance status of 0 to 1.
✕Probably not a fit
Patients with primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma, or those with brain metastasis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness and safety of nivolumab combined with ipilimumab compared to standard chemotherapy with pemetrexed and either cisplatin or carboplatin in patients with unresectable malignant pleural mesothelioma. Participants must have a confirmed diagnosis and measurable disease, and the study will focus on those with advanced disease that cannot be treated with curative intent. The trial will assess outcomes such as tumor response and overall survival in this specific patient population.
Why it matters
Potential benefit: If successful, this treatment combination could offer a new therapeutic option for patients with advanced malignant pleural mesothelioma.
How similar studies have gone: Other studies have shown promising results with similar immunotherapy combinations in various cancers, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Beijing Cancer hospital-Thoracic Cancer Department A
Beijing, Beijing, China Recruiting -
Harbin Medical University Cancer Hospital-oncology of department
Harbin, Heilongjiang, China Recruiting -
The First Affiliated Hospital of Zhengzhou Universtiy-Oncology department
Zhengzhou, Henan, China Recruiting -
Local Institution - 0005
Changsha, Hunan, China Recruiting -
Local Institution - 0023
Wuhan, Hunan, China Recruiting -
Northern Jiangsu People's Hospital-General Surgery Department
Yangzhou, Jiangsu, China Recruiting
Show 20 more locations
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The First Hospital of Jilin University
Changchun, Jilin, China Recruiting -
Liaoning Cancer Hospital-Oncology
Shenyang, Liaoning, China Recruiting -
Local Institution - 0021
Shenyang, Liaoning, China Recruiting -
Local Institution - 0037
Jinan, Shandong, China Recruiting -
Local Institution - 0030
Qingdao, Shandong, China Recruiting -
Shanghai Chest Hospital
Shanghai, Shanghai, China Recruiting -
Shanxi Cancer Hospital
Taiyuan, Shanxi, China Recruiting -
Sichuan Cancer hospital
Chengdu, Sichuan, China Recruiting -
Tianjin Medical University General Hospital-Oncology Department
Tianjin, Tianjin, China Recruiting -
Tianjin Medical University Cancer Institute and Hospital-lung cancer
Tianjin, Tianjin, China Recruiting -
Yunnan Province Cancer Hospital
Kunming, Yunnan, China Recruiting -
The First Affiliated Hospital, Zhejiang University-Respiratory Department
Hangzhou, Zhejiang, China Recruiting -
Zhejiang Cancer Hospital-Thoracic Surgery
Hangzhou, Zhejiang, China Recruiting -
Ningbo Medical Center-respiratory
Ningbo, Zhejiang, China Recruiting -
Local Institution - 0017
Zhengzhou, Henan, China Withdrawn -
Local Institution - 0008
Changsha, Hunan, China Withdrawn -
Local Institution - 0036
Hohhot, Inner Mongolia, China Not yet recruiting -
Local Institution - 0019
Shenyang, Liaoning, China Withdrawn -
Local Institution - 0034
Shanghai, Shanghai, China Not yet recruiting -
Local Institution - 0012
Ningbo, Zhejiang, China Completed
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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First-Line Nivolumab plus Ipilimumab in unresectable hepatocellular carcinoma
This study tests whether the combination of nivolumab and ipilimumab is safe and effective for adults with unresectable liver cancer in real-world care in Japan.
-
30-minute cycling immediately before nivolumab and ipilimumab for metastatic melanoma
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-
VSV-IFNβ-NIS plus ipilimumab and nivolumab for advanced or metastatic clear cell renal cell carcinoma
This trial adds a virus-based therapy (VSV-IFNβ-NIS) to standard immunotherapy (ipilimumab and nivolumab) to see if it helps people with advanced or metastatic clear cell renal cell cancer.
-
Using ctDNA to decide whether to add ipilimumab for people on nivolumab and relatlimab
This tests whether using a ctDNA blood test to guide adding ipilimumab for adults with advanced or metastatic melanoma on nivolumab and relatlimab leads to longer progression-free survival.
-
Neoadjuvant immunotherapy for high-risk eye melanoma
This trial tests whether giving nivolumab and ipilimumab before surgery is safe and feasible for adults with high-risk uveal melanoma.
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Y90 liver radiation plus immunotherapy and targeted drug for unresectable liver cancer
This test will see if adding Y90 liver radiation to nivolumab, ipilimumab, and lenvatinib helps people with unresectable hepatocellular carcinoma live longer and have better tumor responses.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.