Surgery of Melanoma Metastases After Systemic Therapy (SUMMIST)

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.

Study Overview

• Status: Withdrawn
• Conditions: Melanoma; Surgery; Metastatic Melanoma; Melanoma Stage IV
• Intervention / Treatment: Procedure: Surgical metastasectomy; Drug: Immunotherapy

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Immunotherapy; Continued PD1-inhibitor treatment according to current treatment standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS 12 months	Disease free survival	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAE 12 months	Serious adverse events	12 months
Complications	Surgical complications according to the Clavien-Dindo classification	3 months post operatively
R0 resection	Rate of R0 resections according to pathology report	3 months post operatively
PFS 12 months	Progression free survival	12 months
MSS 12 months	Melanoma specific survival	12 months
OS 12 months	Overall survival	12 months

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): September 3, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; Surgical oncology; Metastatic surgery
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: SUMMIST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No