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

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

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.

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