drugset / Trial / NCT04544995

Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)

NCT04544995

Phase 1 Terminated 47 enrolled GlaxoSmithKline
Non-randomizedSequentialOpen-labelTreatment

Summary

This study will evaluate the combination of a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, niraparib, with the programmed cell death protein 1 (PD-1) inhibitor, dostarlimab in the paediatric population. This study will be conducted to determine the recommended Phase 2 dose (RP2D) and evaluate the pharmacokinetics (PK), safety, and efficacy of niraparib in combination with dostarlimab in paediatric participants with recurrent or refractory solid tumors.

Timeline

Start
2020-10-06
Primary completion
2025-04-23
Completion
2025-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Dostarlimab Monoclonal antibody Intravenous
Subject Niraparib Small molecule Oral

Indications