Researchers at the University of Texas MD Anderson Cancer Center, Houston, are conducting an open-label, single-center, randomized noncomparative phase 2 trial to evaluate neoadjuvant checkpoint blockade in patients with surgically resectable soft tissue sarcoma (ClinicalTrials.org Identifier: NCT03307616).1 The study protocol was published in BMC Cancer on September 24, 2018.
The trial will have 2 cohorts on the basis of disease histology. Cohort 1 will have patients with dedifferentiated liposarcoma of the retroperitoneum (RP DDLPS). Cohort 2 will have patients with undifferentiated pleomorphic sarcoma of the trunk or extremity (ET UPS). Each cohort will have 2 treatment arms.
In cohort 1, arm A will receive neoadjuvant nivolumab alone and arm B will receive neoadjuvant nivolumab and ipilimumab in combination. In cohort 2, arm C will receive neoadjuvant nivolumab alone plus concurrent neoadjuvant radiation therapy; arm D will receive neoadjuvant nivolumab and ipilimumab in combination plus concurrent neoadjuvant radiation therapy. Twenty patients will be enrolled in each cohort and then randomly assigned to receive treatment in a 1:1 fashion.
The primary end point is pathologic response, which will be assessed during surgical resection by percent tumor hyalinization. Secondary objectives include toxicity, recurrence-free survival, and overall survival.
“This study will help define the role of single agent anti-PD1 and combination anti-CTLA4 and anti-PD1 therapy in patients with surgically resectable DDLPS and UPS,” wrote the study authors. This trial also builds upon the findings of the SARC028 trial (ClinicalTrials.org Identifier: NCT02301039), which showed clinical activity of pembrolizumab monotherapy in patients with advanced unresectable DDLPS and UPS.
Dislcosure: The study received funding support from Bristol-Myers Squibb.
- Keung EZ, Lazar AJ, Torres KE, et al. Phase II study of neoadjuvant checkpoint blockade in patients with surgically resectable undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. BMC Cancer. 2018;18(1):913. doi: 10.1186/s12885-018-4829-0