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.

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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.

Reference

  1. 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