Clinical trial · Interventional
A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants
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
NCT05136677CI-TRIAL-00101486CheckMate 6DWcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma, Malignant | Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- interventionNames
- Biological: Nivolumab
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Arm B
- interventionNames
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 58 months
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.