CCTG SR8 HARMONY sarcoma trial awarded CIHR funding

The CCTG SR.8 (HARMONY) clinical trial has been awarded almost 1.5 million through the CIHR spring Project Grant Program. Hypofractionated Alternative Radiation with MOdulation of Neoadjuvant/perioperative immunotherapY in Sarcoma is a phase III study that addresses a significant unmet need in the treatment of high-risk soft-tissue sarcoma (STS).

“This Canadian-led phase III trial aims to redefine the nearly two-decade-old standard of care for soft-tissue sarcoma,” says Dr. Philip Wong, SR.8 study chair and Clinician Investigator, Princess Margaret Cancer Centre, UHN.  “With CIHR’s support, we are working to deliver a shorter, more effective therapy that could transform treatment and improve the quality of life for people living with this rare disease.”

Despite the current standard treatments that include surgery and radiation therapy (RT), half of STS patients develop metastases. Innovative treatment strategies are needed to improve the effectiveness of treatment and improve outcomes for this patient population. 

CCTG SR.8 HARMONY aims to evaluate whether the addition of cemiplimab, an anti-PD-1 immunotherapy drug, can reduce the risk of recurrence. The study will also assess whether a shorter preoperative radiation schedule (hypofractionated RT) offers comparable local control to the standard, longer RT regimen.

The trial will enroll 300 patients with high-risk, localized STS and use a randomized design to investigate both questions simultaneously. Participants will be assigned to receive either RT alone, RT with neoadjuvant cemiplimab, or RT with perioperative cemiplimab. Key outcomes include recurrence-free survival and the effectiveness of each RT approach in preventing local tumor recurrence.