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Surgery of Melanoma Metastases After Systemic Therapy (SUMMIST)

V

Vastra Gotaland Region

Status and phase

Withdrawn
Phase 2

Conditions

Melanoma Stage IV
Melanoma
Surgery
Metastatic Melanoma

Treatments

Drug: Immunotherapy
Procedure: Surgical metastasectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04242329
SUMMIST

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

PD1-inhibitor + surgery
Experimental group
Description:
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.
Treatment:
Procedure: Surgical metastasectomy
PD1-inhibitor
Active Comparator group
Description:
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.
Treatment:
Drug: Immunotherapy

Trial contacts and locations

1

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Central trial contact

Roger Olofsson Bagge, MD, PhD

Data sourced from clinicaltrials.gov

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