Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Hematinics

Immunomodulating Agents

Liver Extracts

Immunologic Factors

Patients randomised to the interventional study arm, receiving both surgical metastasectomy and continued immunotherapy. Each patient case will be individually planned for surgery. Procedures will include, but will not be limited to, lung resections, liver resections, bowel resection, skin excisions and lymph node clearances. Patients in both study arms will continue with PD-1 inhibitor 12 months after randomization, and will then be treated according to their medical oncologist.

Patients randomized to control study arm, receiving continued immunotherapy only. Patients in both study arms will continue with PD-1 inhibitor 12 months after randomization, and will then be treated according to their medical oncologist.

Surgical removal of metastases aimed at R0 resection.

Surgical metastasectomy

Continued PD1-inhibitor treatment according to current treatment standards.

Immunotherapy

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.

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.

A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Surgery of Melanoma Metastases After Systemic Therapy	NCT04242329	Melanoma Melanoma Stage ... Metastatic Mela... Surgery	Surgical metast... Immunotherapy	18 Years -	Vastra Gotaland Region
Surgery of Melanoma Metastases After Systemic Therapy	NCT04242329	Melanoma Melanoma Stage ... Metastatic Mela... Surgery	Surgical metast... Immunotherapy	18 Years -	Vastra Gotaland Region

Spots Global Cancer Trial Database for metastatic surgery