cancer lungcancer melanoma (among others)
Conditions
Interventions
None listed
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Starting, or already on treatment with monoclonal antibodies: nivolumab, pembrolizumab and ipilimumab, durvalumab, atezolizumab, trastuzumab and bevacizumab. • 18 years and older. • No known history of increased susceptibility to immunological reactions. • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
Exclusion criteria
Exclusion criteria: • Other research medication within 4 weeks of the start of the study. • Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions • Dosage deviates from standard protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient parameters: • Weight • Height • Body Surface Area (m2) • Sex • Age • Stage of disease • Cancer type Treatment parameters: • Treatment with Nivolumab/ipilimumab/Durvalumab/Bevacizumab/Atezolizumab/Trastuzumab • Dose • Infusion rate • Number of infusions and treatment cycle • Development of IRR • Management of IRR • Cycle of infusion where IRR is developed • Grade of IRR | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard clinical chemistry data for each mAb according to each mAbs standard protocol • Efficacy of treatment parameters (measured until end of study): • Number of treatments needed • Death • Remission • Progression • Plasma levels of the administered mAb • Patient reported experience measurements (PREMs) | — |
Countries
Netherlands
Outcome results
None listed