Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

NCT03673332 | Terminated Phase 4

• 2 other identifiers: EPITOP-01-IPC 2017-0492018-002092-18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Advanced or Metastatic Melanoma; Advanced or Metastatic NSCLC

Keywords

Elderly cancer patients; Immunotherapies

Outcome Measures

Primary Outcomes (2)

• Number of participants adverse events as assessed by CTCAE v5.0

  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)

  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 Outcomes (6)

• geriatric data modifications under treatment

  From inclusion until treatment discontinuation (up to 24 months)

• compare patients and clinician symptoms reporting

  From treatment initiation to 18 weeks after treatment initiation.(up to 24 months)

• Progression-free survival

  time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months)

• Overall Survival

  time from treatment beginning to death of any cause (up to 24 months)

• correlation between toxicity and efficacy

  time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months)

Study Arms (1)

treatment including immune checkpoint inhibitors

EXPERIMENTAL

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

Interventions

immune-checkpoint inhibitors therapies DRUG

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

treatment including immune checkpoint inhibitors

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Francophone d'Onco-Gériatrie: collaborator
• Institut Paoli-Calmettes: lead

Study Sites (9)

Assistance Publique des Hôpitaux de Marseille

Marseille, Bouches Du Rhône, 13385, France

Location

Institut Paoli-Calmettes

Marseille, Bouches-du Rhône, 13009, France

Location

Institut BERGONIE

Bordeaux, France

Location

CENTRE Francois Baclesse

Caen, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Institut Du Cancer de Montpellier

Montpellier, 34298, France

Location

Institut Curie

Paris, France

Location

Institut De Cancérologie de l'Ouest

Saint-Herblain, France

Location

IUCT-Oncopole Institut Claudius Rigaud

Toulouse, France

Location

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MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Renaud Sabatier, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a national prospective phase 4, multi-centre, single arm, open-label cohort study to evaluate the safety and efficacy of immune checkpoint inhibitors-based therapies in elderly patients with advanced or metastatic melanoma or NSCLC.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 17, 2018
• Study Start: October 16, 2019
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: January 22, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)