Full Title: Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Pediatric Participants With Solid Tumors (SCOOP)

Status: Active, Recruiting

Age Range: 6 months to 17 years


Queen Elizabeth University Hospital, Glasgow

University College London Hospital, London

Registry Number: NCT04544995

A cohort extension to include recurrent or refractory osteosarcoma patients is now in place.

This study will evaluate the combination of a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, niraparib, with an immunotherapy drug, the programmed cell death protein 1 (PD-1) inhibitor, dostarlimab in the pediatric 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 pediatric participants with recurrent or refractory solid tumors.

The trial is a multinational study recruiting in France, Spain, and now the United kingdom (Glasgow).

The study is structured in two parts, in Part 1 (dose escalation phase), the recommended Phase 2 dose (RP2D) of the combination of niraparib and dostarlimab will be determined. This will be followed by Part 2 (dose expansion [DE] phase), in which the RP2D established in Part 1 will be evaluated for efficacy and safety.

If you would like any more information on clinical trials in general, please contact us at The Bone Cancer Research Trust. For more information on this trial and to understand if you are eligible, please talk to your clinical team.

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