drugset / Trial / NCT05961761

Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients

NCT05961761

NaSingle-groupOpen-labelTreatment

Summary

The goal of this phase 2 clinical trial is to test efficacy and tolerability of combining propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma. The main questions aims to answer: * Primary: determine the progression-free survival rate (PFSR) at 3 months Secondary: determine the objective response rate (ORR), duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS). Ensure the safety and tolerability, Determine Quality of Life (QoL) • Exploratory: Characterize the TME Participants will be asked to ensure * Baseline biopsy and further optional biopsies * Treatment propranolol 40 mg BID and pembrolizumab 2 mg/kg Q3 weeks * Evaluation, blood counts, QoL and blood samples for biomarkers according to schedule

Timeline

Start
2021-08-17
Primary completion
2028-01
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 2 mg/kg
Subject Propranolol Small molecule 40 mg