Which patients are eligible to participate in clinical trials?

Clinical trials consist of four phases, each of which has its own purpose. We focus on phases 1 and 2, where we look at how the human body reacts to the drug and whether the treatment works for a specific group of patients. For example, we look at the right balance between effectiveness and safety.

Immuuntherapie 2 zorgverleners en patient

Measurable

To determine the effect of the treatment, there must be at least one measurable lesion according to the RECIST 1.1 criteria.
Standard therapy

For most studies, the patient must have had standard treatment first and be progressive on systemic treatment. In some studies, an investigational drug is added to a first-line or second-line standard of care treatment
Organ function

In general, participation should be subject to a minimum eGFR of 60 mL/min or higher and transaminases that are not more than 5x elevated in the presence of liver metastases. For specific inclusion criteria, see the study overview.
Specific tumors

An early clinical trial may focus on one or a limited number of tumor types or tumor characteristics/molecular biomarkers (e.g., a particular mutation, overexpression of a particular protein, or e.g., presence of microsatellite instability or the total number of mutations).
ECOG / WHO
The ECOG / WHO performance score is 0 or 1. This is a prognostic factor and determines the patient's therapy tolerance. These scores stand for:
- 0/ Patient is mainly asymptomatic and active. Patient can function as well without restrictions as before the disease.
- 1/ Patient is limited in physical exertion but is mobile and can do light or sedentary work.
Biopsy of the tumor or metastasis

In most studies, a fresh biopsy is required for participation or there must be an archive of tumor tissue that is of recent date.
On the 'Referral' page you can find more information about referring patients for early clinical trials. You can also refer your patient directly using the form on this page.

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