IMMUNOSARC II Master Trial: Phase II Study of Sunitinib and Nivolumab in Clear Cell Sarcoma Cohort
Based on a previous clinical trial researchers expanded the study of a combination of drugs in the ultra-rare sarcoma called Clear Cell Sarcoma. In this Phase II clinical trial, they treated patients who were confirmed to have Clear Cell Sarcoma and were 12 to 80 years old with the combination of sunitinib, which is a drug that selectively block proteins called tyrosine kinases, and nivolumab, which releases the brakes that tumors put on patients’ immune system by blocking a protein called PD-1 receptor on a specific type of immune cells called T cells. The primary end point was the 6-month progression free survival (PFS) rate with goal of having at least 10 of 23 patients’ progression-free at 6 months. Twenty three patients were evaluable for the primary end point at the cutoff. With a median follow-up of 23.0 months, the 6-month PFS rate was 50.1% with a median PFS of 6.2 months. Additionally, of the 21 patients who underwent at least 1 radiological assessment, 3 (14.3%) had a partial response, 14 (66.7%) had stable disease, and 4 (19.0%) had progressive disease. The median overall survival was 17.0 months. Additional analysis indicated that an increased expression of PD-1 was associated with better PFS. Conclusions: Additional studies are required, but these results indicate that nivolumab plus sunitinib could be useful Clear Cell Sarcoma management.
Read the full study in Cancer Communications.