Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

Last updated: September 25, 2019
Sponsor: Institut Paoli-Calmettes
Overall Status: Active - Recruiting

Phase

4

Condition

Melanoma

Treatment

N/A

Clinical Study ID

NCT03673332
EPITOP-01-IPC 2017-049
2018-002092-18
  • Ages > 70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 beallowed)

  • Age ≥ 70 years

  • Having personally signed and dated informed consent

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

Exclusion

Exclusion Criteria:

  • Immune checkpoint inhibitor therapy initiated before study enrolment

  • Concomitant participation in other investigational clinical trials involving an immunecheckpoint 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 assessedby the investigator

  • Patient in urgency situation, adult under legal protection, or unable to give hisconsent

Study Design

Total Participants: 300
Study Start date:
August 09, 2019
Estimated Completion Date:
December 31, 2021

Study Description

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.

Connect with a study center

  • Assistance Publique des Hôpitaux de Marseille

    Marseille, Bouches Du Rhône 13385
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille, Bouches-du Rhône 13009
    France

    Active - Recruiting

  • Institut BERGONIE

    Bordeaux,
    France

    Site Not Available

  • CENTRE Francois Baclesse

    Caen,
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Institut Du Cancer de Montpellier

    Montpellier, 34298
    France

    Site Not Available

  • Institut Curie

    Paris,
    France

    Site Not Available

  • Institut De Cancérologie de l'Ouest

    Saint-Herblain,
    France

    Site Not Available

  • IUCT-Oncopole Institut Claudius Rigaud

    Toulouse,
    France

    Site Not Available

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