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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03673332
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Société Francophone d'Onco-Gériatrie
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Melanoma Advanced or Metastatic NSCLC Drug: immune-checkpoint inhibitors therapies Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673332


Contacts
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Contact: Dominique GENRE, MD 33 (0)4 91 22 37 78 DRCI.UP@ipc.unicancer.fr
Contact: Margot BERLINE, MSc, MBA 33 (0)4 91 22 37 78 DRCI.UP@ipc.unicancer.fr

Locations
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France
Assistance Publique des Hôpitaux de Marseille Not yet recruiting
Marseille, Bouches Du Rhône, France, 13385
Contact: Elodie Crétel       elodie.cretel@ap-hm.fr   
Institut Paoli-Calmettes Recruiting
Marseille, Bouches-du Rhône, France, 13009
Contact: Dominique GENRE, MD    +33 4 91 22 37 78    drci.up@ipc.unicancer.fr   
Contact: Margot BERLINE, MSc, MBA    +33 4 91 22 33 14    drci.up@ipc.unicancer.fr   
Principal Investigator: Renaud SABATIER, MD         
Institut BERGONIE Not yet recruiting
Bordeaux, France
Contact: Pierre SOUBEYRAN, Dr       p.soubeyran@bordeaux.unicancer.fr   
CENTRE Francois Baclesse Not yet recruiting
Caen, France
Contact: Christelle LEVY, Dr         
Principal Investigator: Christelle LEVY         
Centre Georges François Leclerc Not yet recruiting
Dijon, France, 21079
Contact: Leila BENGRINE-LEFEVRE       lbengrine@cgfl.fr   
Institut Du Cancer de Montpellier Not yet recruiting
Montpellier, France, 34298
Contact: Laurence CRISTOL, MD       laurence.cristol@icm.unicancer.fr   
Institut Curie Not yet recruiting
Paris, France
Contact: Michaël BRINGUIER, Dr       michael.bringuier@curie.fr   
Institut De Cancérologie de l'Ouest Not yet recruiting
Saint-Herblain, France
Contact: Emmanuelle BOURBOULOUX, MD       emmanuelle.bourbouloux@ico.unicancer.fr   
IUCT-Oncopole Institut Claudius Rigaud Not yet recruiting
Toulouse, France
Contact: Loïc MOUREY, Dr       mourey.loic@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Paoli-Calmettes
Société Francophone d'Onco-Gériatrie
Investigators
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Principal Investigator: Renaud Sabatier, MD Institut Paoli-Calmettes
Publications:

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03673332    
Other Study ID Numbers: EPITOP-01-IPC 2017-049
2018-002092-18 ( EudraCT Number )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Institut Paoli-Calmettes:
Elderly cancer patients
Immunotherapies
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas