NCT05961761 Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients
| NCT ID | NCT05961761 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Niels Junker |
| Condition | Soft Tissue Sarcoma Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-08-17 |
| Primary Completion | 2028-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: * 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 * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of ≤2 at the time of enrollment. * Evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). * Available material from archived formalin-fixed paraffin-embedded tumor tissue obtained within 3 months of study