MelanomaPhase 2SUMMISTNCT04242329
Surgery of Melanoma Metastases After Systemic Therapy
A Phase 2 study testing Surgical metastasectomy and Immunotherapy in people with Melanoma and Melanoma Stage IV, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Melanoma Stage IV, Metastatic Melanoma
- What is being tested?
- Surgical metastasectomy and Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 11 Mar 2021to 13 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Brain metastasis (M1d)
- Previous treatment with BRAF/MEK inhibitors
- Inability to understand given information or undergo study procedures according to protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial
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.
Read the 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.
- Conditions
- Melanoma, Melanoma Stage IV, Metastatic Melanoma, Surgery
- Being tested
- Surgical metastasectomy, Immunotherapy
- Keywords
- Immunotherapy, Metastatic surgery, Surgical oncology
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical metastasectomyProcedure or surgery
Surgical removal of metastases aimed at R0 resection.
ImmunotherapyDrug
Continued PD1-inhibitor treatment according to current treatment standards.
| Study group | Role | What they receive |
|---|---|---|
| PD1-inhibitor + surgery | Experimental | 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. Receives: Procedure: Surgical metastasectomy |
| PD1-inhibitor | Active comparator | 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. Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS 12 months
Disease free survival
Measured: 12 months
Secondary outcomes (6)
SAE 12 months
Serious adverse events
Measured: 12 months
Complications
Surgical complications according to the Clavien-Dindo classification
Measured: 3 months post operatively
R0 resection
Rate of R0 resections according to pathology report
Measured: 3 months post operatively
PFS 12 months
Progression free survival
Measured: 12 months
MSS 12 months
Melanoma specific survival
Measured: 12 months
OS 12 months
Overall survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start11 Mar 2021
- Primary completion3 Sep 2023
- Study completion13 Sep 2023
Why it stopped: Not possible to recruit patients during COVID, and not possible to start enrolling after the pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roger Olofsson Bagge, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242329
- Sponsor's protocol ID
- SUMMIST
- Acronym
- SUMMIST
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2020
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial
- ClinicalTrials.gov ID
- NCT04242329
- Acronym / sponsor ID
- SUMMIST / SUMMIST
- Conditions
- Melanoma, Melanoma Stage IV, Metastatic Melanoma, Surgery
- Keywords
- Immunotherapy, Metastatic surgery, Surgical oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not possible to recruit patients during COVID, and not possible to start enrolling after the pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 3 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial
| Arm | Type | Receives |
|---|---|---|
| PD1-inhibitor + surgery | Experimental | Procedure: Surgical metastasectomyPatients 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. |
| PD1-inhibitor | Active comparator | Drug: ImmunotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Brain metastasis (M1d)
- Previous treatment with BRAF/MEK inhibitors
- Inability to understand given information or undergo study procedures according to protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical metastasectomySurgical removal of metastases aimed at R0 resection. | Procedure or surgery | PD1-inhibitor + surgery |
| ImmunotherapyContinued PD1-inhibitor treatment according to current treatment standards. | Drug | PD1-inhibitor |
Primary outcome
DFS 12 months
Time frame: 12 months
Disease free survival
6 secondary outcomes
SAE 12 months
Time frame: 12 months
Complications
Time frame: 3 months post operatively
R0 resection
Time frame: 3 months post operatively
PFS 12 months
Time frame: 12 months
MSS 12 months
Time frame: 12 months
OS 12 months
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgical metastasectomy and Immunotherapy in people with Melanoma and Melanoma Stage IV, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.