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RECRUITING
NCT05961761
PHASE2

Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients

Sponsor: Niels Junker

View on ClinicalTrials.gov

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

Official title: An Open Label Phase 2 Study on Propranolol and Pembrolizumab in Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma - a Scandinavian Sarcoma Group Collaboration

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2021-08-17

Completion Date

2028-12

Last Updated

2023-07-27

Healthy Volunteers

No

Interventions

DRUG

Propranolol

propranolol 40 mg x2 daily

DRUG

Pembrolizumab

pembrolizumab 2 mg/kg every 3 weeks

Locations (4)

Aarhus University Hospital

Aarhus, Denmark

Herlev Gentofte Hospital

Herlev, Denmark

Oslo University Hospital

Oslo, Norway

Karolinska University Hospital

Stockholm, Sweden