Phase Ib study combining dinutuximab beta with induction chemotherapy regimens in patients with newly diagnosed high-risk neuroblastoma: SIOPEN-Pilot01

Written By Carla Aguilera

Chief Investigator:  Prof. dr. Holger Lode

Sponsor: Princess Máxima Center for Pediatric Oncology

Funders / Charity: Recordati

Aims of the study:

  • Main objective: To assess the safety and tolerability and identify the RP2D and MTD of dinutuximab beta when combined with two different induction chemotherapy regimens (GPOH or rapid COJEC) for the treatment of newly diagnosed high-risk neuroblastoma patients as defined by Stage M ≥ 18 months of age and <18 years, according to the INRGSS.

  • Secondary objectives are to characterize the toxicity of induction when combined with DB and to determine the overall and metastatic response during and after the induction.

Phases: Phase 1b

Population: Newly diagnosed high-risk neuroblastoma patients: Stage M age ≥18 months and <18 years, according to the International Neuroblastoma Risk Group Staging System (INRGSS)

Countries: where it is open, recruitment expectations, and where it is in set-up. Total patients recruited to date.

  • Countries open: NL

  • Countries planned to open: ES, FR, DE, IT, PL, IL, UK (17 sites in total)

  • Recruitment: 38 evaluable subjects planned, currently 3 subjects enrolled

  • Set-up done in NL

Link to CT.gov database: Study Details | Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma | ClinicalTrials.gov

Carla Aguilera
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