Prospective sampling in intravenously treated oncology patients: Monoclonal AntiBodies

Monoclonal antibodies are increasingly used as treatment in oncology. Their
pharmacokinetics are largely unknown.

To map the pharmacokinetics of monoclonal antibodies.

Prior to every cycle blood for the study is withdrawn, after treatment
discontinuation blood will be withdrawn until the next treatment line during
regular blood sampling. Optionally, additional blood samples will be withdrawn
at three time points for PK analyses: 2 hours, 48 hours and 7 days after the
first cycle of treatment.

For PBMC characterization, exosome characterization, and ctDNA isolation, and
hemostasis measurements, blood samples will be withdrawn just prior to start of
the treatment and during treatment. In case of progression, PBMC
characterization, exosome characterization, and ctDNA isolation blood samples
could be withdrawn optionally.

The collection of samples for germline DNA will take place only once during
treatment and only for a selected group of patients.

In a group op melanoma patients, collection of feces samples will take place
prior to treatment and on different time-points during treatment with mABs.

In patients with melanoma aged 65 years or older, a short geriatric assessment
(10-15 minutes) will be performed by telephone. During follow-up, patients will
receive short follow-up consults via telephone after 6 months, 1 year and 2
years.

In patients with esophageal cancer a sample of tissue is collected for research
analyses in resected tissue which is obtained during standard of care.

Blood is withdrawn from an i.v. catheter that is already placed for standard of
care. The additional risk for the withdrawal of study samples is negligible.
Risk for collecting feces is considered negligible.
The biopsy of patient with esophageal cancer is derived from resected tissue,
which will be obtained during surgery as part of standard care. Therefore there
is nog additional risk for the patient.