Surgery of Melanoma Metastases After Systemic Therapy

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sahlgrenska University Hospital, Sweden
• Treatments: Immunologic Factors

Criteria

Inclusion Criteria:

• Age above 18 years

• Signed and dated written informed consent before the start of specific protocol procedures

• Biopsy or cytology proven metastatic melanoma stage M1a, M1b or M1c

• Have received a minimum of 9 months of immunotherapy (PD1-inhibitor alone or in combination) resulting in stable disease or partial response according to RECIST 1.1

• Metastases judged to be radically resectable by surgery at a multidisciplinary conference

• ECOG performance status 0-2

Exclusion Criteria:

• Brain metastasis (M1d)

• Previous treatment with BRAF/MEK inhibitors

• Inability to understand given information or undergo study procedures according to protocol