grade 2 or 3 out of 3), high-risk soft tissue sarcoma of the extremity (undifferentiated pleomorphic sarcoma or dedifferentiated/pleomorphic liposarcoma, tumor size > 5 cm
Conditions
Brief summary
Disease-free survival will be the primary efficacy endpoint. Disease recurrence is defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site distant to the primary tumor, including nodal metastasis, loco-regional recurrence, and death without documented recurrence.
Detailed description
1. To evaluate the loco-regional recurrence-free survival (RFS), the distant disease free survival, and overall survival (OS) in both patient cohorts. 2. To test the safety of neoadjuvant pembrolizumab administered with conventionally fractionated radiotherapy targeting soft tissue sarcoma of the extremity
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Fondazione IRCCS Istituto Nazionale Dei Tumori, Sarcoma Alliance for Research through Collaboration
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival will be the primary efficacy endpoint. Disease recurrence is defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site distant to the primary tumor, including nodal metastasis, loco-regional recurrence, and death without documented recurrence. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the loco-regional recurrence-free survival (RFS), the distant disease free survival, and overall survival (OS) in both patient cohorts. 2. To test the safety of neoadjuvant pembrolizumab administered with conventionally fractionated radiotherapy targeting soft tissue sarcoma of the extremity | — |
Countries
Italy
Outcome results
None listed