Melanoma, Melanoma Stage IV, Metastatic Melanoma, Surgery
Conditions
Keywords
Immunotherapy, Metastatic surgery, Surgical oncology
Brief 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.
Interventions
PROCEDURESurgical metastasectomy
Surgical removal of metastases aimed at R0 resection.
DRUGImmunotherapy
Continued PD1-inhibitor treatment according to current treatment standards.
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS 12 months | 12 months | Disease free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 3 months post operatively | Surgical complications according to the Clavien-Dindo classification |
| R0 resection | 3 months post operatively | Rate of R0 resections according to pathology report |
| SAE 12 months | 12 months | Serious adverse events |
| MSS 12 months | 12 months | Melanoma specific survival |
| OS 12 months | 12 months | Overall survival |
| PFS 12 months | 12 months | Progression free survival |
Countries
Sweden
Outcome results
None listed