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Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients

NCT05961761 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-07-27

No results posted yet for this study

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

Conditions

Interventions

DRUG

Propranolol

propranolol 40 mg x2 daily

DRUG

Pembrolizumab

pembrolizumab 2 mg/kg every 3 weeks

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Niels Junker

    lead OTHER

Principal Investigators

  • Niels Junker, MD, PhD · Herlev and Gentofte Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2028-01-31
Completion
2028-12-31

Countries

  • Denmark
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05961761 on ClinicalTrials.gov