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

Primary Purpose

Advanced or Metastatic Melanoma, Advanced or Metastatic NSCLC

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
immune-checkpoint inhibitors therapies
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Metastatic Melanoma focused on measuring Elderly cancer patients, Immunotherapies

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique des Hôpitaux de Marseille
  • Institut Paoli-CalmettesRecruiting
  • Institut BERGONIE
  • CENTRE Francois Baclesse
  • Centre Georges François Leclerc
  • Institut Du Cancer de Montpellier
  • Institut Curie
  • Institut De Cancérologie de l'Ouest
  • IUCT-Oncopole Institut Claudius Rigaud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment including immune checkpoint inhibitors

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

geriatric data modifications under treatment
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.
compare patients and clinician symptoms reporting
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.
Progression-free survival
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.
Overall Survival
Overall Survival (OS) will be defined as the time from treatment beginning to death of any cause.
correlation between toxicity and efficacy
Correlation between occurrence of auto-immune adverse events (with a landmark time at week 18) and efficacy (PFS).
rate of grade 3 to 5 adverse events 18 weeks after treatment initiation
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.

Full Information

First Posted
August 21, 2018
Last Updated
September 25, 2019
Sponsor
Institut Paoli-Calmettes
Collaborators
Société Francophone d'Onco-Gériatrie
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1. Study Identification

Unique Protocol Identification Number
NCT03673332
Brief Title
Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies
Acronym
EPITOP-01
Official Title
Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Société Francophone d'Onco-Gériatrie

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Melanoma, Advanced or Metastatic NSCLC
Keywords
Elderly cancer patients, Immunotherapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment including immune checkpoint inhibitors
Arm Type
Experimental
Arm Description
All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.
Intervention Type
Drug
Intervention Name(s)
immune-checkpoint inhibitors therapies
Intervention Description
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 Measure Information:
Title
Number of participants adverse events as assessed by CTCAE v5.0
Description
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.
Time Frame
From treatment initiation to 18 weeks after treatment initiation. (up to 24 months)
Title
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)
Description
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.
Time Frame
From inclusion until 24 weeks after treatment initiation (up to 24 months)
Secondary Outcome Measure Information:
Title
geriatric data modifications under treatment
Description
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.
Time Frame
From inclusion until treatment discontinuation (up to 24 months)
Title
compare patients and clinician symptoms reporting
Description
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.
Time Frame
From treatment initiation to 18 weeks after treatment initiation.(up to 24 months)
Title
Progression-free survival
Description
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 Frame
time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months)
Title
Overall Survival
Description
Overall Survival (OS) will be defined as the time from treatment beginning to death of any cause.
Time Frame
time from treatment beginning to death of any cause (up to 24 months)
Title
correlation between toxicity and efficacy
Description
Correlation between occurrence of auto-immune adverse events (with a landmark time at week 18) and efficacy (PFS).
Time Frame
time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months)
Title
rate of grade 3 to 5 adverse events 18 weeks after treatment initiation
Description
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.
Time Frame
From treatment initiation to 18 weeks after treatment initiation.(up to 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
33 (0)4 91 22 37 78
Email
DRCI.UP@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Margot BERLINE, MSc, MBA
Phone
33 (0)4 91 22 37 78
Email
DRCI.UP@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud Sabatier, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique des Hôpitaux de Marseille
City
Marseille
State/Province
Bouches Du Rhône
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie Crétel
Email
elodie.cretel@ap-hm.fr
Facility Name
Institut Paoli-Calmettes
City
Marseille
State/Province
Bouches-du Rhône
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique GENRE, MD
Phone
+33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Margot BERLINE, MSc, MBA
Phone
+33 4 91 22 33 14
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Renaud SABATIER, MD
Facility Name
Institut BERGONIE
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre SOUBEYRAN, Dr
Email
p.soubeyran@bordeaux.unicancer.fr
Facility Name
CENTRE Francois Baclesse
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle LEVY, Dr
First Name & Middle Initial & Last Name & Degree
Christelle LEVY
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leila BENGRINE-LEFEVRE
Email
lbengrine@cgfl.fr
Facility Name
Institut Du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence CRISTOL, MD
Email
laurence.cristol@icm.unicancer.fr
Facility Name
Institut Curie
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaël BRINGUIER, Dr
Email
michael.bringuier@curie.fr
Facility Name
Institut De Cancérologie de l'Ouest
City
Saint-Herblain
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle BOURBOULOUX, MD
Email
emmanuelle.bourbouloux@ico.unicancer.fr
Facility Name
IUCT-Oncopole Institut Claudius Rigaud
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loïc MOUREY, Dr
Email
mourey.loic@iuct-oncopole.fr

12. IPD Sharing Statement

Plan to Share IPD
No
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