Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNiels Junker
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
Histologically confirmed diagnosis of unresectable locally advanced or metastatic Angiosarcoma or Undifferentiated Pleomorphic Sarcoma, who has progressed/failed to provide clinical benefit on first line standard chemotherapy.
Age ≥18 years
Disqualifiers
Have an anticipated life expectancy of <3 months.
Moderate to severe degree of bronchial asthma or chronic obstructive pulmonary disease.
Acute or non-stable congestive heart failure
Any other condition listed as contraindication for treatment with propranolol according to SPC
Trial design
Design model
Single group
Treatments tested in this trial
Propranolol
Drugpropranolol 40 mg x2 daily
Pembrolizumab
Drugpembrolizumab 2 mg/kg every 3 weeks
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Propranolol + pembrolizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival rate
Determine the progression-free survival rate (PFSR) at 3 months by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame
3 monthsSecondary outcomes
1
Objective response rate
Determine the objective response rate (ORR) using RECIST v 1.1
Time frame
Approximately 6 months2
Duration of Response
Duration of Response (DOR) measured as time from response to progression according to RECIST v 1.1 or death.
Time frame
Up to 2 years3
Progression Free Survival
Progression Free Survival (PFS) according to RECIST v 1.1
Time frame
Up to 2 years4
Overall Survival
Overall Survival (OS).
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Niels Junker
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
Aarhus University Hospital
Collaborator
Oslo University Hospital
Collaborator
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov