Malignant Pleural Mesothelioma Clinical Trial
Official title:
Phase 2 Trial of TGF-β Inhibition (OT-101) With Anti-PD-1 (Pembrolizumab) in Patients With Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition
This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.
This is a phase 2, open label, non-randomized, single arm Simon's two stage study in subjects with malignant pleural mesothelioma failing to achieve or maintain response to checkpoint inhibition. Before the efficacy assessment portion, the study will first embark a run-in dose-escalation phase to evaluate safety and tolerability of various dose of OT-101 in combination of pembrolizumab, and to determine a recommended Phase 2 dose (RP2D) of 4 days continuous I.V. infusion for every two weeks regimen. Subjects received the RP2D in the run-in dose-escalation phase will be part of the first stage of the Simon's two-stage design for effectiveness evaluation. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06037941 -
Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma
|
N/A | |
| Completed |
NCT01675765 -
Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
|
Phase 1 | |
| Withdrawn |
NCT04201145 -
Pembrolizumab + Defactinib In Pleural Mesothelioma
|
Phase 1 | |
| Completed |
NCT03048474 -
Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma
|
Phase 2 | |
| Completed |
NCT02369198 -
MesomiR 1: A Phase I Study of TargomiRs as 2nd or 3rd Line Treatment for Patients With Recurrent MPM and NSCLC
|
Phase 1 | |
| Terminated |
NCT01870609 -
Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Active, not recruiting |
NCT00886028 -
Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Completed |
NCT00272558 -
Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma
|
Phase 2 | |
| Active, not recruiting |
NCT02436733 -
Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage MPM
|
Phase 2 | |
| Completed |
NCT04843007 -
Alvopem® (Pemetrexed) Safety Assessment
|
||
| Completed |
NCT01721018 -
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT00797719 -
Short Neoadjuvant Hemithoracic IMRT for MPM
|
Phase 1/Phase 2 | |
| Completed |
NCT00386815 -
Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Recruiting |
NCT03715933 -
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
|
Phase 1 | |
| Completed |
NCT04775446 -
Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy
|
||
| Completed |
NCT01865045 -
Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients
|
||
| Completed |
NCT01644994 -
Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma
|
Phase 1/Phase 2 | |
| Completed |
NCT00571298 -
Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma
|
Phase 1 | |
| Recruiting |
NCT01343264 -
Trimodality Therapy for Malignant Pleural Mesothelioma
|
N/A | |
| Active, not recruiting |
NCT04162015 -
A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma
|
Phase 1 |