- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03888950
Interim FDG PET-CT in Melanoma Metastatic Patient's Treated by Anti-PD1 Therapy (TEP-ANTI-PD1)
Early Response Assessment With Interim FDG PET-CT Imaging in Patients With Advanced Melanoma Treated by Immune Checkpoint Inhibitors Therapy Anti-PD1
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The management and prognosis of patients with metastatic cutaneous melanoma have changed dramatically with the advent of immunotherapy, especially anti-PD-1 antibodies. These immune-checkpoint inhibitor block the programmend cell death receptor 1 (PD1). Currently, two anti-PD-1 antibodies, nivolumab and pembrolizumab are available. Recent data for pembrolizumab show that the overall survival rate at almost 3 years is 50% and the overall response rate is 42%. Despite these results so far never achieved, about 60% of patients do not respond to anti-PD-1 immunotherapy and, at present, no clinical, imaging or biological markers are predictive of the therapeutic response. The identification of such markers is essential in order to guide the clinician in the choice of optimal treatment.
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.
The anti-tumor immune response to anti-PD-1 is related to the activation of immune cells infiltrating the tumor, in particular CD8+ (cluster of differentiation 8) T cells whose phenotype is that of "exhausted T cells". This immune activation is such that it sometimes causes (about 10% of cases) a transient increase in the size and/or number of lesions. This phenomenon, has been called "pseudo-progression" and it cannot be interpreted routinely by RECIST1.1 criteria. The exact kinetics and timing of CD8+ T cell activation leading to response to treatment is still unknown. It is possible that this cellular activation has an early metabolic translation detectable by 18FDG PET-CT. The investigator's hypothesis is that early 18FDG PET-CT, ie after 2 cycles of anti-PD1 in metastatic patient melanoma, could be predictive of the therapeutic response. 20 patients will be enrolled and undergo three PET/CT scans: a baseline PET-CT (PET0) before the start of anti-PD1 treatment, an early PET-CT after 2 cycles of anti-PD1 (PET1) and a third PET-CT after 3 months of initiation of treatment. Treatment response on FDG PET will be assessed according to PERCIST criteria. Changes in FDG uptake will be correlated with blood results.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Micheline RAZZOUK-CADET, MD
- Phone Number: +33492035671
- Email: razzouk-cadet.m@chu-nice.fr
Study Contact Backup
- Name: Delphine DEL CONT
- Email: delcont.d@chu-nice.fr
Study Locations
-
-
Chu de Nice
-
Nice, Chu de Nice, France, 06003
- Recruiting
- CHU de Nice
-
Contact:
- Phone Number: 0492034702
- Email: razzouk-cadet.m@chu-nice.fr
-
Principal Investigator:
- Micheline RAZZOUK-CADET
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: early research PET-CT
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
|
FDG PET/CT for oncological imaging of adult patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantifying changes in FDG uptake according to PERCIST criteria:Single-lesion analysis
Time Frame: 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)
|
-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
Time Frame: 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)
|
- 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
Time Frame: 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)
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of SUL peak of the most avid lesions
Time Frame: 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)
|
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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Micheline RAZZOUK-CADET, MD, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-AOIP-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Melanoma
-
Mohammed M MilhemGenentech, Inc.TerminatedMelanoma | Metastatic Melanoma | BRAF-mutated Metastatic Melanoma | V600EBRAF-mutated Metastatic MelanomaUnited States
-
Delcath Systems Inc.Active, not recruitingMetastatic Uveal Melanoma | Metastatic Ocular MelanomaUnited States
-
National Cancer Institute (NCI)TerminatedMetastatic Uveal Melanoma | Metastatic Ocular MelanomaUnited States
-
MorphotekTerminatedMelanoma | Metastatic Melanoma | Advanced Melanoma | Malignant Metastatic MelanomaUnited States
-
GlaxoSmithKlineWithdrawnCancer | Metastatic Uveal Melanoma | GNA11 Mutation-positive Metastatic Melanoma | GNAQ Mutation-positive Metastatic Melanoma
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMetastatic Melanoma | Metastatic Uveal Melanoma | Unresectable Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC v8 | Pathologic Stage III Cutaneous... and other conditionsUnited States
-
Elizabeth DavisBristol-Myers SquibbTerminatedMetastatic Melanoma | Advanced Melanoma | Metastatic Melanoma Stratified by MHC-II ExpressionUnited States
-
Fred Hutchinson Cancer CenterAmazon.com Services LLCRecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Cutaneous Melanoma | Unresectable Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC... and other conditionsUnited States
-
Provectus Biopharmaceuticals, Inc.Active, not recruitingMetastatic Colorectal Cancer | Hepatocellular Carcinoma | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Melanoma | Metastatic Uveal Melanoma | Metastatic Pancreatic Cancer | Metastatic Colon Cancer | Metastatic Ocular Melanoma | Cancer Metastatic to the LiverUnited States
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Recurrent Cutaneous Melanoma | Clinical Stage IV Cutaneous Melanoma AJCC v8 | Recurrent Mucosal Melanoma | Metastatic Mucosal Melanoma | Non-Cutaneous Melanoma | Metastatic Non-Cutaneous Melanoma | Recurrent Non-Cutaneous...United States, Canada, Ireland
Clinical Trials on FDG PET-CT
-
Washington University School of MedicineTerminatedCervical Cancer | Uterine Cervical Neoplasms | Uterine Cervical CancerUnited States
-
University of UtahNational Cancer Institute (NCI)CompletedFluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) in Cancer Associated VenothromboembolismVenothromboembolismUnited States
-
Peter MacCallum Cancer Centre, AustraliaMelbourne Health; Westmead Hospital; Victorian Infectious Diseases Reference...CompletedAcute Myeloid Leukemia | Febrile Neutropenia | Acute Lymphoblastic Leukemia | Haematopoietic Stem Cell Transplant, Autologous | Haematopoietic Stem Cell Transplant, AllogeneicAustralia
-
Region VästerbottenUmeå UniversityRecruitingCervix Cancer | Endometrial Cancer | Epithelial Ovarian CancerSweden
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedMalignant Neoplasm of Breast TNM Staging Distant Metastasis (M) | Untreated Bone MetastasesUnited States
-
Jewish General HospitalRecruitingVasculitis | Giant Cell ArteritisCanada
-
Institute of Oncology LjubljanaUniversity of LjubljanaUnknownCorrelation of iRADIOMICS and irRC With SurvivalSlovenia
-
Centre Hospitalier Universitaire Saint PierreCompletedExtrapulmonary Tuberculosis in HIV Patients
-
Abramson Cancer Center at Penn MedicineActive, not recruiting
-
University of ZurichWithdrawnAdenocarcinoma | Stomach Cancer | Cancer of Esophagogastric JunctionSwitzerland