Neoadjuvant Immunotherapy of Operable Metastatic Melanoma... | NCT06586593

Studies
Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)

NCT06586593

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

77Estimated

Phase

Not provided

Conditions

Melanoma Metastatic

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2023Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Jan 2025Estimated

First Submitted Date

Sep 4, 2024

First Submission Date that Met QC Criteria

Sep 5, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.

The complete histological response will be assessed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77Estimated

Label	Type	Description	Intervention Names
Operable metastatic melanoma		Operable metastatic melanoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete histological response	Histological response rate on histological analysis of the resected specimen	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Objectival response rate	Objectival response rate on imaging	Day 1
Event-free survival	An event is defined by progression of the disease or toxicity making surgery impossible, the impossibility of starting adjuvant treatment within 84 days following surgery, recurrence of melanoma after surgery or death.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer [AJCC] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient's refusal to be operated.
Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed

Exclusion Criteria:

Uveal melanoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with operable metastatic melanoma (stade III or IV of AJCC) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charlée NARDIN, MD PhD	Contact			cnardin@chu-besancon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Angers	Active, not recruiting	Angers			France
CHU de Besançon

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided