NCT04242329

Surgery of Melanoma Metastases After Systemic Therapy

Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate if surgical removal of residual disease adds benefit in stage IV melanoma patients with partial response or stable disease after a minimum 9 months of first-line PD-1 inhibition. Primary endpoint: Disease-free survival (DFS) at 12 months.

Detailed description

A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial. Patients with metastatic melanoma, stratified for stage M1a or M1b/M1c, that have received first-line treatment with PD-1 inhibitors for a minimum of 9 months resulting in either partial response or stable disease according to RECIST 1.1 will be eligible. Patients will be screened for operability based on CT-scans examined by a multidisciplinary team, with the criteria that complete (R0) resection of all metastases should be possible. If the multidisciplinary team find that this would be possible, patients will be included and randomized 1:1 to either surgery with continued PD1-inhibition or current standard of care with continued PD1-inhibition only. At progression, treatment will be according to the treating medical oncologist. Active follow-up will be performed for 12 months.

Conditions

• Melanoma
• Melanoma Stage IV
• Metastatic Melanoma
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Surgical metastasectomy	Surgical removal of metastases aimed at R0 resection.
DRUG	Immunotherapy	Continued PD1-inhibitor treatment according to current treatment standards.

Timeline

• Start date: 2021-03-11
• Primary completion: 2023-09-03
• Completion: 2023-09-13
• First posted: 2020-01-27
• Last updated: 2024-01-26

Locations

1 site across 1 country: Sweden