Clinical trial · Interventional
DENdritic Cell Immunotherapy for Mesothelioma
A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy
NCT03610360CI-TRIAL-00073555DENIMcompletedPhase 2 / Phase 3ClinicalTrials.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)
This study is to evaluate the overall survival (OS) rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.
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 Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MesoPher | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Arm A will receive the study drug MesoPher plus best supportive care
- interventionNames
- Drug: MesoPher
- type
- NO_INTERVENTION
- label
- Arm B
- description
- Arm B will follow best supportive care as deemed appropriate by the investigator.
Primary outcomes (1)
- measure
- Overall survival rate
- timeFrame
- from randomisation to study end (the last visit for the last subject participating in the study and the last data collection point completed) assessed in up to 102 weeks
- description
- The primary outcome measure of this study is to evaluate the overall survival (OS) rate of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone. Overall survival rate will be determined from randomisation until death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Subjects will only be included with a histologically confirmed diagnosis of pleural malignant mesothelioma, who are non-progressive after 4 to 6 cycles with first line chemotherapy with antifolate/platinum.
References
Publications (1)
- DERIVEDAerts JG, Belderbos R, Baas P, Scherpereel A, Bezemer K, Enninga I, Meijer R, Willemsen M, Berardi R, Fennell D, Kerstens R, Cornelissen R, van Meerbeeck JP; DENIM team. Dendritic cells loaded with allogeneic tumour cell lysate plus best supportive care versus best supportive care alone in patients with pleural mesothelioma as maintenance therapy after chemotherapy (DENIM): a multicentre, open-label, randomised, phase 2/3 study. Lancet Oncol. 2024 Jul;25(7):865-878. doi: 10.1016/S1470-2045(24)00191-8. Epub 2024 Jun 4. PMID 38848742