Surgery of Melanoma Metastases After Systemic Therapy

Surgery Clinical Trial

— SUMMIST  

Official title:

Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04242329
• Other study ID #: SUMMIST
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 11, 2021
• Est. completion date: September 13, 2023

Study information

• Verified date: January 2024
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 13, 2023
• Est. primary completion date: September 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma Stage IV
• Metastatic Melanoma
• Surgery

Intervention

Procedure:
• Surgical metastasectomy
Surgical removal of metastases aimed at R0 resection.

Drug:
• Immunotherapy
Continued PD1-inhibitor treatment according to current treatment standards.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS 12 months	Disease free survival	12 months
Secondary	SAE 12 months	Serious adverse events	12 months
Secondary	Complications	Surgical complications according to the Clavien-Dindo classification	3 months post operatively
Secondary	R0 resection	Rate of R0 resections according to pathology report	3 months post operatively
Secondary	PFS 12 months	Progression free survival	12 months
Secondary	MSS 12 months	Melanoma specific survival	12 months
Secondary	OS 12 months	Overall survival	12 months