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

NCT04544995 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-01-21

Study results available
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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.

Conditions

  • Neoplasms

Interventions

DRUG

Niraparib (Tablet for oral suspension)

Niraparib will be administered as TfOS (Tablet for oral suspension)

DRUG

Dostarlimab

Dostarlimab will be administered as IV infusion

DRUG

Niraparib (Tablet)

Niraparib will be administered as tablet

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2025-04-23
Completion
2025-04-23
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04544995 on ClinicalTrials.gov