18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma

Study Purpose

The hypothesis of this diagnostic performance study is that, for patients treated for immunotherapy-treated melanoma or NSCLC, some metabolic parameters of the 18FDG dual-point PET scan distinguish inflammatory pseudo-progression from tumor progression true and thus improve the evaluation of tumor response to immunotherapy

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age > or = 18 years, - Patients with unresectable melanoma or histologically proven, metastatic or locally advanced NSCLC, - Indication of an immunotherapy treatment with nivolumab or pembrolizumab validated in multidisciplinary consultation team and prescribed as part of their marketing authorization, in first or second line of treatment, - Performance Status 0 to 2, - Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication.

If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required,

- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication.

Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year,

- Male subjects should agree to use an adequate method of contraception or abstain from heterosexual activity starting with the first dose of study therapy through 6 months after the last dose of study therapy, - Patient willing and able to provide written informed consent/assent for the trial, - Patient affiliated with a health insurance system.

Exclusion Criteria:

- Age < 18 years, - Contraindication to performing 18FDG PET scans: severe claustrophobia, unbalanced diabetes during PET examinations (fasting capillary blood glucose ≥ 11 mmol), - Any participation in other biomedical studies related to the drug, medical devices or imaging techniques is prohibited except biomedical studies called overstudies (In case of doubt or questions about the patient's participation in a other clinical study, please contact the sponsor), - Contraindication to nivolumab or pembrolizumab treatment, - Patient with metastatic disease, - History of thoracic irradiation or near / in the thoracic irradiation field, - Patient who refuses to participate in the study or unable to agree, - Patient currently receiving one or more treatments described in section 6.9 of the protocol, - Contraindication to nivolumab or pembrolizumab treatment, - People particularly vulnerable as defined in Articles L.

1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside a state to express their consent, pregnant or breastfeeding women.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03584334
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Antoine Lacassagne
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Non-Small Cell Bronchopulmonary Carcinoma or Melanoma

Additional Details

The originality of this study is based on the stakes of the early prediction of resistance to immunotherapy (early therapeutic escapes, side effects, cost of treatment etc.). No prospective study has been published to date on the value of 18FDG PET to distinguish between true tumor progression and pseudo-progression. Studies are therefore needed to define new criteria for evaluating the metabolic response specific to immunotherapy, as well as the optimal timing of the interim examination. The goal is to conduct a transversal, non-randomized, prospective, multi-center, diagnostic performance study, harmonizing the moments of the 18FDG PET scans, acquisition conditions and interpretation criteria. The use of a dual-point acquisition in PET will also make it possible to judge the kinetics of 18FDG lesion capture (calculation of the 18FDG retention index on the late image) with the objective of highlighting PET criteria to distinguish between inflammatory pseudo-progression and true tumor progression in patients with unresectable melanoma or advanced or metastatic NSCLC. Other metabolic parameters will be studied, such as changes in tumor metabolic volume and binding intensities. Finally, this study will include patients to assess the correlation between the metabolic tumor response observed after 7 weeks of immunotherapy, the morphological response after 3 months of treatment (RECIST v1.1 and i-RECIST) and survival overall at 1 year.

Arms & Interventions

Arms

Other: 18FDG PET

Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells

Interventions

Radiation: - 18FDG PET

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Antoine Lacassagne, Nice, France

Status

Recruiting

Address

Centre Antoine Lacassagne

Nice, , 06189

Site Contact

Olivier HUMBERT, MD

[email protected]

+3 34 92 03 1778

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