Surgery of Melanoma Metastases After Systemic Therapy
NCT04242329 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2024-01-26
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.
Conditions
- Melanoma
- Melanoma Stage IV
- Metastatic Melanoma
- Surgery
Interventions
- PROCEDURE
-
Surgical metastasectomy
Surgical removal of metastases aimed at R0 resection.
- DRUG
-
Immunotherapy
Continued PD1-inhibitor treatment according to current treatment standards.
Sponsors & Collaborators
-
Vastra Gotaland Region
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-11
- Primary Completion
- 2023-09-03
- Completion
- 2023-09-13
Countries
- Sweden
Study Locations
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