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Durvalumab D419EC00001 (hematological/solid tumors)

Clinical study to evaluate the safety, tolerability and efficacy of durvalumab, or durvalumab in combination with tremelimumab, in young patients with advanced solid tumors or hematological malignancies.
Who can enter
  • Children and teenagers with a type of pediatric cancer in whom the disease has returned (relapse) or responded insufficiently to treatment (refractory).
  • Age: 0 up to and including 17 years.

Goal

The goal of this study is to find out more about the potential use of two study drugs (durvalumab and tremelimumab) in children with cancer. We will mainly focus on the safety and tolerability of these study drugs in children. In addition, we will try to find out whether children with relapsed or refractory disease may benefit from these study drugs.


Background

For children and teenagers with relapsed or refractory cancer, treatment options are limited. Furthermore, conventional therapies often produce long-term side effects. That is why we are looking for new therapies with fewer side effects.

Durvalumab and tremelimumab are both antibodies (immunotherapy), and therefore not chemotherapy. The aim of these drugs is to enable the natural defense system of our body (the immune system) to attack the tumor. The immune system can recognize and destroy tumor cells. Tumor cells try to avoid this by putting different brakes on the immune system. The drugs durvalumab and tremelimumab release these brakes, so the immune system can again attack the tumor cells.

Durvalumab has been approved (registered) for the treatment of adults with certain types of lung cancer. Tremelimumab has not yet been approved for use in the EU and USA. Durvalumab has already been tested in a few children, but thus far there has been no study with tremelimumab in children. However, a drug of the same type as tremelimumab worked well in children with melanoma and has been approved for use in children in some countries.

Studies evaluating treatment with the combination durvalumab + tremelimumab are already ongoing in adult patients. In this study we want to see whether these two drugs work well in solid tumors and in blood cancers such as leukemia (hematological malignancies). Especially in hematological malignancies there is no experience yet with this combination of drugs in children.

This study is now closed for inclusion.

Last reviewed

February 15, 2022