NCT04793737

Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate tumor response, survival and adverse effects after precision radiotherapy (SBRT) in melanoma patients with ongoing PD-1 inhibitor treatment that have tumor progression.

Detailed description

A phase II open-label multicenter trial evaluating response rate (RR) in patients receiving precision radiation (SBRT) to melanoma metastasis that have progressed on PD-1 inhibitor therapy. Patients will continue on PD-1 inhibitor therapy (pembrolizumab or nivolumab) for up to one year after completed precision radiation and will be followed-up for 24 months or until disease progression or death. The primary endpoint of the study is overall response rate (ORR) in non-irradiated lesions. The study will be conducted according to Simon´s two Stage minimax Design. Patients will be enrolled in two batches, first consisting of 13 patients. If no objective responses (complete response (CR) or partial response (PR)) are reported after the first stage, the study is interrupted early for futility. When the 13th patient is recruited, if there is at least one objective response in patient´s non-irradiated lesion(s), the recruitment can proceed into second stage. 14 more patients will then be included up to a total of 27 patients to determine ORR along with the 95% confidence interval. The test result is considered positive when at least 15% of the patients have a confirmed objective response.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
RADIATION	Precision Radiation (SBRT)	Precision radiation of melanoma metastases

Timeline

• Start date: 2021-03-08
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-03-11
• Last updated: 2025-03-05

Locations

1 site across 1 country: Sweden