Evaluating nivolumab and ipilimumab for treating advanced malignant pleural mesothelioma in Chinese patients
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
PHASE2 · Bristol-Myers Squibb · NCT05136677
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Drugs / interventions | chemotherapy, nivolumab, ipilimumab |
| Locations | 26 sites (Beijing, Beijing and 25 other locations) |
| Trial ID | NCT05136677 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma, or those with brain metastasis may not benefit from this study.
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 performed: Other studies have shown promising results with similar immunotherapy combinations in various cancers, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Beijing, Beijing and 25 other locations
- Beijing Cancer hospital-Thoracic Cancer Department A — Beijing, Beijing, China (RECRUITING)
- Harbin Medical University Cancer Hospital-oncology of department — Harbin, Heilongjiang, China (RECRUITING)
- Local Institution - 0017 — Zhengzhou, Henan, China (WITHDRAWN)
- The First Affiliated Hospital of Zhengzhou Universtiy-Oncology department — Zhengzhou, Henan, China (RECRUITING)
- Local Institution - 0008 — Changsha, Hunan, China (WITHDRAWN)
- Local Institution - 0005 — Changsha, Hunan, China (RECRUITING)
- Local Institution - 0023 — Wuhan, Hunan, China (RECRUITING)
- Local Institution - 0036 — Hohhot, Inner Mongolia, China (NOT_YET_RECRUITING)
- Northern Jiangsu People's Hospital-General Surgery Department — Yangzhou, Jiangsu, China (RECRUITING)
- The First Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)
- Local Institution - 0019 — Shenyang, Liaoning, China (WITHDRAWN)
- 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)
- Local Institution - 0034 — Shanghai, Shanghai, China (NOT_YET_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)
- Local Institution - 0012 — Ningbo, Zhejiang, China (COMPLETED)
- Ningbo Medical Center-respiratory — Ningbo, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mesothelioma, Malignant, Malignant Pleural Mesothelioma, Nivolumab, Ipilimumab