Clinical trial · Interventional
Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies
Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial
NCT03673332CI-TRIAL-00101369EPITOP-01terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of recruitment
Summary
Brief summary (as posted)
The co-primary objectives will be to assess the safety and quality of life under treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Melanoma | — | UNRESOLVED | — |
| Advanced or Metastatic NSCLC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immune-checkpoint inhibitors therapies | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment including immune checkpoint inhibitors
- description
- All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.
- interventionNames
- Drug: immune-checkpoint inhibitors therapies
Primary outcomes (2)
- measure
- Number of participants adverse events as assessed by CTCAE v5.0
- timeFrame
- From treatment initiation to 18 weeks after treatment initiation. (up to 24 months)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (43)
- BACKGROUNDBalducci 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. PMID 10884501
- BACKGROUNDBasch 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. PMID 17081915
- BACKGROUNDBorghaei 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. PMID 26412456
- BACKGROUNDBrahmer 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. PMID 22658128
- BACKGROUNDBrahmer 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. PMID 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.