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Clinical Trial Summary

The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.


Clinical Trial Description

After being informed about the study and potential risks, all patients will undergo a 2-week screening period to determine eligibility for study entry. After informed consent has been obtained, all patients ≤ 25 years and patients > 25 years without metastases will receive Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to standard induction chemotherapy (3 blocks of cisplatin/5-fluorouracil). In patients not responding to induction chemotherapy, the application of Nivolumab will be extended throughout the period of radiochemotherapy. Patients > 25 years with metastatic disease will receive Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to induction chemotherapy with 3 blocks of cisplatin/gemcitabine. All patients with metastatic disease will continue to receive Nivolumab during radiochemotherapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06019130
Study type Interventional
Source German Society for Pediatric Oncology and Hematology GPOH gGmbH
Contact Helena Kerp, PhD
Phone +49 201 74 94 96 14
Email h.kerp@forschung-paediatrie.de
Status Recruiting
Phase Phase 2
Start date January 10, 2023
Completion date January 9, 2028

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