Actively Recruiting
Phase 2 Study of Propranolol with Pembrolizumab for Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma
Led by Niels Junker · Updated on 2023-07-27
80
Participants Needed
4
Research Sites
47 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma, two aggressive types of soft tissue sarcomas. This phase 2 trial aims to determine the progression-free survival rate at 3 months and assess other outcomes like response rate, overall survival, safety, tolerability, and quality of life. The study also explores the tumor microenvironment to understand immune responses better. Participants will receive propranolol at 40 mg twice daily and pembrolizumab at 2 mgkg every 3 weeks until disease progression, unacceptable side effects, or withdrawal, for up to two years. The study is open-label and single-arm with two separate cohorts, enrolling up to 40 patients per group. Baseline and optional biopsies will be collected for biomarker studies. During the trial, participants will undergo regular evaluations including blood tests, quality of life questionnaires, and biomarker blood samples according to a schedule. Researchers will monitor treatment safety using established criteria and measure tumor responses by standard imaging criteria. The total participation duration can last up to two years, with ongoing assessments of survival and quality of life.
CONDITIONS
Brief Title
Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients
Research Team
N
Niels Junker, MD, PhD
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