Actively Recruiting
An Open Label Phase 2 Study on Propranolol and Pembrolizumab in Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma - a Scandinavian Sarcoma Group Collaboration
Led by Niels Junker · Updated on 2023-07-27
80
Participants Needed
4
Research Sites
47 weeks
Total Duration
On this page
Sponsors
N
Niels Junker
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
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 mg/kg 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent following regulatory guidelines before any study procedures
- Willingness and ability to comply with visits, treatment, and testing requirements
- Histologically confirmed unresectable locally advanced or metastatic angiosarcoma or undifferentiated pleomorphic sarcoma
- Age 18 years or older
- ECOG Performance Status score of 0, 1, or 2 at enrollment
- Disease measurable by RECIST version 1.1 criteria
- Archived tumor tissue within 3 months or willingness to undergo biopsy for biomarker studies
- Normal organ and bone marrow function based on specified blood counts and lab values
- Women of childbearing potential must agree to use effective contraception during treatment and for 120 days after
- Men sexually active with women of childbearing potential must use effective contraception during treatment and for 120 days after
- Women not of childbearing potential and azoospermic men are exempt from contraception requirements
You will not qualify if you...
- Life expectancy less than 3 months
- Moderate to severe bronchial asthma or chronic obstructive pulmonary disease
- Acute or unstable congestive heart failure
- Any contraindication to propranolol treatment as per product guidelines
- Prior treatment with PD-1/PD-L1 immune checkpoint inhibitors
- Propranolol use within 4 weeks before treatment start
- Radiation, chemotherapy, targeted therapy within 2 weeks or monoclonal antibody treatment within 4 weeks before study day one
- Not recovered from effects of previous treatments
- Clinically active or unstable central nervous system metastases
- Serious or uncontrolled medical conditions increasing risk or interfering with study treatment or results
- Active, known or suspected autoimmune disease except certain controlled conditions
- Need for systemic corticosteroids over 10 mg prednisone equivalents or other immunosuppressive drugs
- Known HIV infection or AIDS
- History of allergy to study drugs or severe hypersensitivity to monoclonal antibodies
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive pembrolizumab every 3 weeks and propranolol twice daily until disease progression, unacceptable toxicity, or withdrawal, for up to two years.
Visits every 3 weeks for pembrolizumab dosing and regular assessments
Trial Site Locations
Total: 4 locations
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Not Yet Recruiting
2
Herlev Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
3
Oslo University Hospital
Oslo, Norway
Actively Recruiting
4
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
Research Team
N
Niels Junker, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here