Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies (EPITOP-01)

January 20, 2026 updated by: Institut Paoli-Calmettes

Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Institut Bergonie
      • Caen, France
        • Centre François Baclesse
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Montpellier, France, 34298
        • Institut du Cancer de Montpellier
      • Paris, France
        • Institut Curie
      • Saint-Herblain, France
        • Institut de Cancérologie de l'Ouest
      • Toulouse, France
        • IUCT-Oncopole Institut Claudius Rigaud
    • Bouches Du Rhône
      • Marseille, Bouches Du Rhône, France, 13385
        • Assistance Publique des Hôpitaux de Marseille
    • Bouches-du Rhône
      • Marseille, Bouches-du Rhône, France, 13009
        • Institut Paoli-Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants adverse events as assessed by CTCAE v5.0
Time Frame: From treatment initiation to 18 weeks after treatment initiation. (up to 24 months)
Description of adverse events' type, incidence, severity (CTCAE v.5.0), timing, seriousness, and relatedness. This endpoint will be based on the rate of grade ≥ 3 adverse events 18 weeks after treatment initiation, defined as medical assessment of safety including adverse events' type, incidence, severity (graded by the CTCAE] v. 5.0), timing, seriousness, and relatedness. This will include clinical as well as biological toxicities such as liver and endocrine dysfunctions. All high grade adverse events will be taken into account.
From treatment initiation to 18 weeks after treatment initiation. (up to 24 months)
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (QLQ-C30) and Elderly Cancer Patients module (QLQ - ELD14), combined to compute a total score (between 44 and 128 points)
Time Frame: From inclusion until 24 weeks after treatment initiation (up to 24 months)
Quality of life will be evaluated using the EORTC QLQ-C30 and QLQ-ELD14 questionnaires collected at inclusion and at every treatment cycles during the first 6 weeks, then every 6 weeks until treatment discontinuation. The proportion of patients with a decrease superior or equal to 10% for their global score between baseline and at 24 weeks after treatment initiation will be estimated.
From inclusion until 24 weeks after treatment initiation (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
geriatric data modifications under treatment
Time Frame: From inclusion until treatment discontinuation (up to 24 months)
Geriatric data assessment will be done at inclusion and every 6 weeks until treatment discontinuation. Exhaustive data will be collected at inclusion. The investigators will also assess the G-CODE (Geriatric Core Dataset), a recently described minimum geriatric data set (see SOFOG guidelines). G-CODE assessment will be repeated every 6 weeks during treatment and at treatment discontinuation. These data will be collected either by the geriatrician or trained clinical research nurses during geriatric consultation as part of geriatric follow-up, an integral part of the patient management.
From inclusion until treatment discontinuation (up to 24 months)
compare patients and clinician symptoms reporting
Time Frame: From treatment initiation to 18 weeks after treatment initiation.(up to 24 months)
Reminder of CTCAE version 5.0 will be completed by clinicians before every treatment cycle. Patients will also complete a language adapted version of patient-reported outcome PRO-CTCAE questionnaire. For all symptoms, the investigators will measure the proportion of pairs for which clinicians and patients gave an identical grade. The investigators will also measure the proportion of pairs that will disagree for each symptom by one point (e.g., patient grade 2 and clinician grade 1), and the proportion that will disagree by two or more points (e.g., patient grade 2 and clinician grade 4). The investigators will also record the number of symptoms for which each pair agreed.
From treatment initiation to 18 weeks after treatment initiation.(up to 24 months)
Progression-free survival
Time Frame: time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months)
Evaluation of Progression-free Survival (PFS) will be defined as the time from treatment beginning to radiological (according to the RECIST 1.1 criteria) or clinical progression of the disease as declared by the investigators, or death of any cause. Radiological evaluations will be performed every 6 weeks.
time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months)
Overall Survival
Time Frame: time from treatment beginning to death of any cause (up to 24 months)
Overall Survival (OS) will be defined as the time from treatment beginning to death of any cause.
time from treatment beginning to death of any cause (up to 24 months)
correlation between toxicity and efficacy
Time Frame: time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months)
Correlation between occurrence of auto-immune adverse events (with a landmark time at week 18) and efficacy (PFS).
time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months)
rate of grade 3 to 5 adverse events 18 weeks after treatment initiation
Time Frame: From treatment initiation to 18 weeks after treatment initiation.(up to 24 months)
Safety profiles comparison according to treatment regimen (PD1-inhibitor monotherapy vs PD1- inhibitor/CTLA4-inhibitor combination vs CTLA-inhibitor monotherapy vs PDL1-inhibitor if available at time of trial beginning) will be performed by looking at the rate of grade 3 to 5 adverse events 18 weeks after treatment initiation for each therapy.
From treatment initiation to 18 weeks after treatment initiation.(up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

Société Francophone d'Onco-Gériatrie

Investigators

  • Principal Investigator: Renaud Sabatier, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2019

Primary Completion (Actual)

October 29, 2024

Study Completion (Actual)

October 29, 2024

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPITOP-01-IPC 2017-049
  • 2018-002092-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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