RecruitingPhase 2NCT05961761

Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients

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


Sponsor

Niels Junker

Enrollment

80 participants

Start Date

Aug 17, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding propranolol (a common beta-blocker heart medication) to pembrolizumab (a well-known immunotherapy drug) improves outcomes in people with advanced soft tissue sarcomas — specifically angiosarcoma or undifferentiated pleomorphic sarcoma — that have stopped responding to standard chemotherapy. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of unresectable locally advanced or metastatic angiosarcoma or undifferentiated pleomorphic sarcoma - Your cancer has progressed after at least one line of standard chemotherapy - Your overall health is acceptable (ECOG 0–2) and organ function meets required levels - You have measurable tumor(s) by standard imaging **You may NOT be eligible if...** - You have moderate-to-severe asthma or severe COPD (propranolol can worsen these conditions) - You have acute or unstable heart failure - You have previously received pembrolizumab or any other PD-1/PD-L1 immunotherapy - You have received propranolol within the past 4 weeks - You have active autoimmune disease requiring systemic treatment (with some exceptions for mild conditions) - You have HIV or AIDS - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropranolol

propranolol 40 mg x2 daily

DRUGPembrolizumab

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

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NCT05961761


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