Actively Recruiting
Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients
Led by Niels Junker · Updated on 2023-07-27
80
Participants Needed
4
Research Sites
380 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
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
Official Title
Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Willing and able to follow study visits, treatment, and testing
- Histologically confirmed unresectable locally advanced or metastatic angiosarcoma or undifferentiated pleomorphic sarcoma
- Age 18 years or older
- ECOG performance status of 0, 1, or 2 at enrollment
- Measurable disease based on RECIST version 1.1
- Available tumor tissue from recent biopsy or archived sample within 3 months before enrollment
- Normal organ and bone marrow function as defined by ANC 6 1 x 10^9/L, platelets 6 75 x 10^9/L, bilirubin 4 1.5 times ULN (with exceptions for Gilbert's Syndrome), AST/ALT 4 5 times ULN, creatinine 4 1.5 times ULN or creatinine clearance 7 40 mL/min
- Women of childbearing potential must agree to use effective contraception during treatment and for 120 days afterward
- Sexually active men with partners of childbearing potential must use effective contraception during treatment and for 120 days afterward
- Women not of childbearing potential and azoospermic men do not require contraception
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 condition contraindicated for propranolol use
- Previous treatment with PD-1/PD-L1 inhibitors or other immune checkpoint blockers
- Propranolol use within 4 weeks before treatment
- Radiation, chemotherapy, targeted therapy within 2 weeks or monoclonal antibody treatment within 4 weeks before study start
- Not recovered from effects of prior treatments
- Active or unstable central nervous system metastases
- Serious or uncontrolled medical conditions increasing risk or interfering with study
- Active, known, or suspected autoimmune diseases (exceptions apply for certain stable conditions)
- Need for systemic corticosteroids over 10 mg prednisone daily or other immunosuppressive medications
- Known HIV infection or AIDS
- Allergy to study drugs or severe hypersensitivity to monoclonal antibodies
- Pregnant or breastfeeding women of childbearing potential
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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