Clinical trial · Interventional
Surgery of Melanoma Metastases After Systemic Therapy
Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial
NCT04242329CI-TRIAL-00073345SUMMISTwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not possible to recruit patients during COVID, and not possible to start enrolling after the pandemic.
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Drug | Immunotherapy | ALIAS |
| Surgical metastasectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PD1-inhibitor + surgery
- description
- 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.
- interventionNames
- Procedure: Surgical metastasectomy
- type
- ACTIVE_COMPARATOR
- label
- PD1-inhibitor
- description
- 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.
- interventionNames
- Drug: Immunotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.