Surgery of Melanoma Metastases After Systemic Therapy (SUMMIST)
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|ClinicalTrials.gov Identifier: NCT04242329|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Melanoma Stage IV Metastatic Melanoma Surgery||Procedure: Surgical metastasectomy Drug: Immunotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial|
|Masking:||None (Open Label)|
|Official Title:||Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: PD1-inhibitor + surgery
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.
Procedure: Surgical metastasectomy
Surgical removal of metastases aimed at R0 resection.
Active Comparator: PD1-inhibitor
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.
Continued PD1-inhibitor treatment according to current treatment standards.
- DFS 12 months [ Time Frame: 12 months ]Disease free survival
- SAE 12 months [ Time Frame: 12 months ]Serious adverse events
- Complications [ Time Frame: 3 months post operatively ]Surgical complications according to the Clavien-Dindo classification
- R0 resection [ Time Frame: 3 months post operatively ]Rate of R0 resections according to pathology report
- PFS 12 months [ Time Frame: 12 months ]Progression free survival
- MSS 12 months [ Time Frame: 12 months ]Melanoma specific survival
- OS 12 months [ Time Frame: 12 months ]Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242329
|Contact: Roger Olofsson Bagge, MD, PhDemail@example.com|
|Sahlgrenska University Hospital|
|Gothenburg, Sweden, 413 45|