NCT03888950

Brief Summary

The objective of this study is to assess whether FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET-CT could be an early predictive method of therapeutic response to anti-PD-1 immunotherapy in metastatic melanoma after 2 cycles of ANTI-PD1. 20 patients will be enrolled and undergo three PET/CT scans: a baseline PET-CT, an early research PET-CT after 2 cycles of anti-PD1 (PET1) and a PET-CT at 3 months of initiation of treatment. Treatment response on FDG PET-CT will be assessed according to PERCIST criteria.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress79%
Nov 2020Nov 2027

First Submitted

Initial submission to the registry

March 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2022

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 18, 2019

Last Update Submit

March 18, 2025

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (3)

  • Quantifying changes in FDG uptake according to PERCIST criteria:Single-lesion analysis

    -Single-lesion analysis: by measuring % change in SULpeak of the one lesion with the highest SUL on PET0 and PET1 and PET2 (not necessarily the same lesion),

    Before the start of anti-PD1 treatment (PET0)(day 0), after 2 cycles of anti-PD1 (PET1) (between day 21 and day 31) and after 3 months of initiation of treatment(PET2)

  • Quantifying changes in FDG uptake according to PERCIST criteria: Five lesion analysis

    \- Five lesion analysis: by summing the SULpeak of up to 5 lesions with highest FDG uptake (maximum of two per organ).

    Before the start of anti-PD1 treatment (PET0)(day 0), after 2 cycles of anti-PD1 (PET1) (between day 21 and day 31) and after 3 months of initiation of treatment(PET2)

  • Determine the number of lesions

    Before the start of anti-PD1 treatment (PET0)(day 0), after 2 cycles of anti-PD1 (PET1) (between day 21 and day 31) and after 3 months of initiation of treatment(PET2)

Secondary Outcomes (1)

  • Analysis of SUL peak of the most avid lesions

    Before the start of anti-PD1 treatment (PET0)(day 0), after 2 cycles of anti-PD1 (PET1) (between day 21 and day 31) and after 3 months of initiation of treatment(PET2)

Study Arms (1)

early research PET-CT

EXPERIMENTAL

The patient will undergo an early research PET-CT after 2 cycles of anti-PD1 (PET1) between the baseline PET-CT and the PET-CT at 3 months of initiation of treatment

Diagnostic Test: FDG PET-CT

Interventions

FDG PET-CTDIAGNOSTIC_TEST

FDG PET/CT for oncological imaging of adult patients

early research PET-CT

Eligibility Criteria

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

You may qualify if:

  • Age greater than or equal to 18 years,
  • Patient with advanced melanoma proved histologically, not BRAF mutated, BRAFV600 mutated and wild mutated, cutaneous or unknown primary melanoma having an indication of treatment with anti-PD-1 immunotherapy by nivolumab or Pembrolizumab,
  • Patient having social insurance,
  • Patient who has signed informed consent.

You may not qualify if:

  • Age less than 18 years,
  • Patient with ocular or mucosal melanoma,
  • Contraindication to PET CT examination: Severe claustrophobia, unbalanced diabetes (fasting hairy blood glucose ≥ 11 mmol),
  • Patient with only metastatic lesions less than 8 mm in size, with the exception of pulmonary nodules,
  • HIV and/or HCV (hepatitis C virus) and/or HBV (hepatitis B virus) positive serology, active autoimmune disease,
  • Withdrawal of informed consent,
  • Metastatic disease not confirmed histologically.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, CHU de NICE, 06003, France

RECRUITING

MeSH Terms

Conditions

Melanoma

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

Study Officials

  • Micheline RAZZOUK-CADET, MD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Micheline RAZZOUK-CADET, MD

CONTACT

+33492035671razzouk-cadet.m@chu-nice.fr

Delphine DEL CONT

CONTACT

delcont.d@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 25, 2019

Study Start

November 24, 2020

Primary Completion

November 24, 2022

Study Completion (Estimated)

November 1, 2027

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)