Clinical Trials /

Surgery of Melanoma Metastases After Systemic Therapy

NCT04242329

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04242329

Trial Eligibility

Document

Title

  • Brief Title: Surgery of Melanoma Metastases After Systemic Therapy
  • Official Title: Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial

Clinical Trial IDs

  • ORG STUDY ID: SUMMIST
  • NCT ID: NCT04242329

Conditions

  • Melanoma
  • Melanoma Stage IV
  • Metastatic Melanoma
  • Surgery

Interventions

DrugSynonymsArms
ImmunotherapyPD1-inhibitor

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PD1-inhibitor + surgeryExperimentalPatients 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-inhibitorActive ComparatorPatients 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.
    • Immunotherapy

    Eligibility Criteria

            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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:DFS 12 months
    Time Frame:12 months
    Safety Issue:
    Description:Disease free survival

    Secondary Outcome Measures

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

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Sahlgrenska University Hospital, Sweden

    Trial Keywords

    • Immunotherapy
    • Metastatic surgery
    • Surgical oncology

    Last Updated

    March 17, 2021