Spots Global Cancer Trial Database for OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition
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Trial Identification
Brief Title: OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition
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
Study ID: NCT05425576
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Contact Details
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