Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Observational, multicenter, single-arm study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L01XC17) nivolumab
nivolumab

Medical condition to be studied

Metastatic malignant melanoma
Non-small cell lung cancer metastatic
Population studied

Age groups

  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Special population of interest

Immunocompromised

Estimated number of subjects

1200
Study design details

Main study objective

As additional pharmacovigilance measure in the post-approval EU RMP for nivolumab, the study will assess the use pattern and safety/effectiveness profile of nivolumab and the management strategies and outcomes of identified risks associated with nivolumab treatment for melanoma and lung cancer in routine oncology practice. This study will generate data to inform future risk minimization efforts.

Outcomes

Primary Endpoints:Immune-related pneumonitisImmune-related colitisImmune-related hepatitisImmune-related nephritis/renal dysfunctionImmune-related endocrinopathies Immune-related skin reactions Other immune-related, adverse reactionsSevere infusion reactions, Secondary Endpoints:Other nivolumab treatment-related AEsManagement of Immune-related AEsOutcomes of Immune-related AEsOverall SurvivalNivolumab treatment pattern

Data analysis plan

Incidence rates of immune-related AEs as in primary objective calculated separately for melanoma and lung cancer. Other immune-related AEs analyzed as combined endpoint. # and % of patients whose immune-related AEs are managed according to recommended strategies will be summarized. Approaches to diagnose AEs are summarized by # and % for immune-related AEs. Doses/duration of systemic corticosteroids, of non-corticosteroid treatment, hormone therapies/other treatment modalities will be summarized. AE Outcomes to present with # and % of patients experiencing outcomes presented separately for those managed with recommended algorithms and those not. Data on deaths to summarize as follows: # and % of all deaths, of deaths ≤ 30d of last dose received, of deaths ≤ 1 to 5 yrs after initiation of nivolumab. Analyze survival with Kaplan-Meier plots. Calculate survival rates & the corresponding 95% CIs, median survival and 95% CIs.