Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

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Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

Study Purpose

The co-primary objectives will be to assess the safety and quality of life under treatment.

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	70 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients eligible to start a treatment including immune checkpoint inhibitors (Nivolumab, Ipilimumab, Pembrolizumab, and so on.

..)

- Diagnosis of advanced or metastatic melanoma or NSCLC (All treatment lines will be allowed) - Age ≥ 70 years.

- Having personally signed and dated informed consent.

- Patient affiliated to the ''National security'' regimen or beneficiary of this regimen.

Exclusion Criteria:

- Immune checkpoint inhibitor therapy initiated before study enrolment.

- Concomitant participation in other investigational clinical trials involving an immune checkpoint inhibitor.

- Immune checkpoint inhibitor treatment in a context of other solid tumours.

- Immune checkpoint inhibitor treatment in a context of haematological malignancies.

- Being unable or unwilling to comply with the requirements of the protocol, as assessed by the investigator.

- Patient in urgency situation, adult under legal protection, or unable to give his consent

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.	NCT03673332
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.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Paoli-Calmettes
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Renaud Sabatier, MD
Principal Investigator Affiliation	Institut Paoli-Calmettes
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced or Metastatic Melanoma, Advanced or Metastatic NSCLC

Additional Details

The co-primary objectives will be to assess the safety and quality of life under treatment. Secondary objectives will be evaluations of geriatric data modifications under treatment, efficacy (progression-free survival and overall survival), correlation between toxicity and efficacy, and comparison of the safety profiles between various immunotherapy regimens. Another secondary objective will be the comparison between patients and clinicians symptom reporting. The investigators will also perform a pharmacokinetics analysis on PD1-monoclonal antibodies to improve the understanding of PD-1 inhibitors pharmacokinetics for the elderly population. Finally, toxicity and efficacy will be compared to immunological parameters such as the description of tumor infiltrating lymphocytes, markers of immunosenescence and inflammation.

Arms & Interventions

Arms

Experimental: treatment including immune checkpoint inhibitors

All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.

Interventions

Drug: - immune-checkpoint inhibitors therapies

All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.

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

Marseille, Bouches Du Rhône, France

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Assistance Publique des Hôpitaux de Marseille

Marseille, Bouches Du Rhône, 13385

Institut Paoli-Calmettes, Marseille, Bouches-du Rhône, France

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Institut Paoli-Calmettes

Marseille, Bouches-du Rhône, 13009

Institut BERGONIE, Bordeaux, France

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Institut BERGONIE

Bordeaux, ,

CENTRE Francois Baclesse, Caen, France

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CENTRE Francois Baclesse

Caen, ,

Centre Georges François Leclerc, Dijon, France

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Centre Georges François Leclerc

Dijon, , 21079

Institut Du Cancer de Montpellier, Montpellier, France

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Institut Du Cancer de Montpellier

Montpellier, , 34298

Institut Curie, Paris, France

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Institut Curie

Paris, ,

Institut De Cancérologie de l'Ouest, Saint-Herblain, France

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Institut De Cancérologie de l'Ouest

Saint-Herblain, ,

IUCT-Oncopole Institut Claudius Rigaud, Toulouse, France

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IUCT-Oncopole Institut Claudius Rigaud

Toulouse, ,

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