Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgery of Melanoma Metastases After Systemic Therapy (SUMMIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242329
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma Melanoma Stage IV Metastatic Melanoma Surgery Procedure: Surgical metastasectomy Drug: Immunotherapy Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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.




Primary Outcome Measures :
  1. DFS 12 months [ Time Frame: 12 months ]
    Disease free survival


Secondary Outcome Measures :
  1. SAE 12 months [ Time Frame: 12 months ]
    Serious adverse events

  2. Complications [ Time Frame: 3 months post operatively ]
    Surgical complications according to the Clavien-Dindo classification

  3. R0 resection [ Time Frame: 3 months post operatively ]
    Rate of R0 resections according to pathology report

  4. PFS 12 months [ Time Frame: 12 months ]
    Progression free survival

  5. MSS 12 months [ Time Frame: 12 months ]
    Melanoma specific survival

  6. OS 12 months [ Time Frame: 12 months ]
    Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242329


Contacts
Layout table for location contacts
Contact: Roger Olofsson Bagge, MD, PhD +46707462119 roger.olofsson.bagge@gu.se

Locations
Layout table for location information
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Layout table for additonal information
Responsible Party: Roger Olofsson Bagge, Associate professor, Senior Consultant Surgeon, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04242329    
Other Study ID Numbers: SUMMIST
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden:
Immunotherapy
Metastatic surgery
Surgical oncology
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas