Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

Last updated: January 20, 2026
Sponsor: Institut Paoli-Calmettes
Overall Status: Terminated

Phase

4

Condition

Melanoma

Treatment

immune-checkpoint inhibitors therapies

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 thisregimen

Exclusion

Exclusion Criteria:

  • Immune checkpoint inhibitor therapy initiated before study enrolment

  • Concomitant participation in other investigational clinical trials involving animmune 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, asassessed by the investigator

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

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: immune-checkpoint inhibitors therapies
Phase: 4
Study Start date:
October 16, 2019
Estimated Completion Date:
October 29, 2024

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

  • Assistance Publique des Hôpitaux de Marseille

    Marseille 2995469, Bouches Du Rhône 13385
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille, Bouches-du Rhône 13009
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille 2995469, Bouches-du Rhône 13009
    France

    Site Not Available

  • Institut BERGONIE

    Bordeaux,
    France

    Site Not Available

  • Institut BERGONIE

    Bordeaux 3031582,
    France

    Site Not Available

  • CENTRE Francois Baclesse

    Caen,
    France

    Site Not Available

  • CENTRE Francois Baclesse

    Caen 3029241,
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon 3021372, 21079
    France

    Site Not Available

  • Institut Du Cancer de Montpellier

    Montpellier, 34298
    France

    Site Not Available

  • Institut Du Cancer de Montpellier

    Montpellier 2992166, 34298
    France

    Site Not Available

  • Institut Curie

    Paris,
    France

    Site Not Available

  • Institut Curie

    Paris 2988507,
    France

    Site Not Available

  • Institut De Cancérologie de l'Ouest

    Saint-Herblain,
    France

    Site Not Available

  • Institut De Cancérologie de l'Ouest

    Saint-Herblain 2979590,
    France

    Site Not Available

  • IUCT-Oncopole Institut Claudius Rigaud

    Toulouse,
    France

    Site Not Available

  • IUCT-Oncopole Institut Claudius Rigaud

    Toulouse 2972315,
    France

    Site Not Available

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