Spots Global Cancer Trial Database for Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

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Trial Identification

Brief Title: Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

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 ID: NCT03673332

Conditions

Advanced or Metastatic Melanoma

Advanced or Metastatic NSCLC

Interventions

immune-checkpoint inhibitors therapies

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.