AzTrials
AzTrials

Advanced or Metastatic MelanomaPhase 4EPITOP-01NCT03673332

Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

A Phase 4 study testing immune-checkpoint inhibitors therapies in people with Advanced or Metastatic Melanoma and Advanced or Metastatic NSCLC, run by Institut Paoli-Calmettes at 9 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The co-primary objectives will be to assess the safety and quality of life under treatment. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
immune-checkpoint inhibitors therapies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
9 sitesFrance
Study dates
16 Oct 2019to 29 Oct 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Institut BERGONIE

    Bordeaux

  • CENTRE Francois Baclesse

    Caen

  • Centre Georges François Leclerc

    Dijon, 21079

  • Assistance Publique des Hôpitaux de Marseille

    Marseille, Bouches Du Rhône, 13385

  • Institut Paoli-Calmettes

    Marseille, Bouches-du Rhône, 13009

  • Institut Du Cancer de Montpellier

    Montpellier, 34298

  • Institut Curie

    Paris

  • Institut De Cancérologie de l'Ouest

    Saint-Herblain

  • IUCT-Oncopole Institut Claudius Rigaud

    Toulouse

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
immune-checkpoint inhibitors therapies
Keywords
Elderly cancer patients, Immunotherapies
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • immune-checkpoint inhibitors therapiesDrug

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

Study groups in NCT03673332
Study groupRoleWhat they receive
treatment including immune checkpoint inhibitorsExperimentalAll patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.
Receives: Drug: immune-checkpoint inhibitors therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  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)

    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.

    Measured: From inclusion until 24 weeks after treatment initiation (up to 24 months)

Secondary outcomes (6)

  1. 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.

    Measured: From inclusion until treatment discontinuation (up to 24 months)

  2. 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.

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

  3. 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.

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

  4. Overall Survival

    Overall Survival (OS) will be defined as the time from treatment beginning to death of any cause.

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

  5. correlation between toxicity and efficacy

    Correlation between occurrence of auto-immune adverse events (with a landmark time at week 18) and efficacy (PFS).

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2018
  2. Study start16 Oct 2019
  3. Primary completion29 Oct 2024
  4. Study completion29 Oct 2024

Why it stopped: lack of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03673332
Sponsor's protocol ID
EPITOP-01-IPC 2017-049
Other IDs
2018-002092-18, 2018
Acronym
EPITOP-01
Status last verified
May 2025
First submitted
21 Aug 2018
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Balducci L, Extermann M. Management of cancer in the older person: a practical approach. Oncologist. 2000;5(3):224-37. doi: 10.1634/theoncologist.5-3-224.

    PubMed 10884501

  • Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.

    PubMed 17081915

  • Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

    PubMed 26412456

  • Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

    PubMed 22658128

  • Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

    PubMed 26028407

  • Cella D, Grunwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6.

    PubMed 27283863

  • Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, Chaput N, Eggermont A, Marabelle A, Soria JC, Ferte C. Hyperprogressive Disease Is a New Pattern of Progression in Cancer Patients Treated by Anti-PD-1/PD-L1. Clin Cancer Res. 2017 Apr 15;23(8):1920-1928. doi: 10.1158/1078-0432.CCR-16-1741. Epub 2016 Nov 8.

    PubMed 27827313

  • Daste A, Domblides C, Gross-Goupil M, Chakiba C, Quivy A, Cochin V, de Mones E, Larmonier N, Soubeyran P, Ravaud A. Immune checkpoint inhibitors and elderly people: A review. Eur J Cancer. 2017 Sep;82:155-166. doi: 10.1016/j.ejca.2017.05.044. Epub 2017 Jul 6.

    PubMed 28689093

  • Du-Thanh A, Lesage C, Ferreira E, Dereure O, Guillot B. [Innovative therapies for metastatic melanoma in elderly patients]. Ann Dermatol Venereol. 2015 Oct;142(10):549-56. doi: 10.1016/j.annder.2015.03.022. Epub 2015 May 16. French.

    PubMed 25986740

  • Extermann M. Measurement and impact of comorbidity in older cancer patients. Crit Rev Oncol Hematol. 2000 Sep;35(3):181-200. doi: 10.1016/s1040-8428(00)00090-1.

    PubMed 10960800

  • Fitzsimmons D, Gilbert J, Howse F, Young T, Arrarras JI, Bredart A, Hawker S, George S, Aapro M, Johnson CD. A systematic review of the use and validation of health-related quality of life instruments in older cancer patients. Eur J Cancer. 2009 Jan;45(1):19-32. doi: 10.1016/j.ejca.2008.07.036. Epub 2008 Sep 25.

    PubMed 18823775

  • Greenhalgh J. The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res. 2009 Feb;18(1):115-23. doi: 10.1007/s11136-008-9430-6. Epub 2008 Dec 23.

    PubMed 19105048

  • Helissey C, Vicier C, Champiat S. The development of immunotherapy in older adults: New treatments, new toxicities? J Geriatr Oncol. 2016 Sep;7(5):325-33. doi: 10.1016/j.jgo.2016.05.007. Epub 2016 Jun 16.

    PubMed 27318796

  • Hjermstad MJ, Fayers PM, Bjordal K, Kaasa S. Using reference data on quality of life--the importance of adjusting for age and gender, exemplified by the EORTC QLQ-C30 (+3). Eur J Cancer. 1998 Aug;34(9):1381-9. doi: 10.1016/s0959-8049(98)00136-1.

    PubMed 9849421

  • Hua C, Boussemart L, Mateus C, Routier E, Boutros C, Cazenave H, Viollet R, Thomas M, Roy S, Benannoune N, Tomasic G, Soria JC, Champiat S, Texier M, Lanoy E, Robert C. Association of Vitiligo With Tumor Response in Patients With Metastatic Melanoma Treated With Pembrolizumab. JAMA Dermatol. 2016 Jan;152(1):45-51. doi: 10.1001/jamadermatol.2015.2707.

    PubMed 26501224

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing immune-checkpoint inhibitors therapies in people with Advanced or Metastatic Melanoma and Advanced or Metastatic NSCLC, run by Institut Paoli-Calmettes at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03673332, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in