NCT04242329

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 11, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

2.5 years

First QC Date

January 23, 2020

Last Update Submit

January 25, 2024

Conditions

MelanomaMelanoma Stage IVMetastatic MelanomaSurgery

Keywords

ImmunotherapyMetastatic surgerySurgical oncology

Outcome Measures

Primary Outcomes (1)

  • DFS 12 months

    Disease free survival

    12 months

Secondary Outcomes (6)

  • SAE 12 months

    12 months

  • Complications

    3 months post operatively

  • R0 resection

    3 months post operatively

  • PFS 12 months

    12 months

  • MSS 12 months

    12 months

  • +1 more secondary outcomes

Study Arms (2)

PD1-inhibitor + surgery

EXPERIMENTAL

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

PD1-inhibitor

ACTIVE COMPARATOR

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

Interventions

Surgical metastasectomyPROCEDURE

Surgical removal of metastases aimed at R0 resection.

PD1-inhibitor + surgery
ImmunotherapyDRUG

Continued PD1-inhibitor treatment according to current treatment standards.

PD1-inhibitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Brain metastasis (M1d)
  • Previous treatment with BRAF/MEK inhibitors
  • Inability to understand given information or undergo study procedures according to protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Melanoma

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Senior Consultant Surgeon

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 27, 2020

Study Start

March 11, 2021

Primary Completion

September 3, 2023

Study Completion

September 13, 2023

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)