Niraparib and Dostarlimab for Recurrent or Refractory Solid Tumours

  • Research type

    Research Study

  • Full title

    A PHASE 1, MULTICENTRE, OPEN-LABEL, DOSE-ESCALATION AND COHORT EXPANSION STUDY OF NIRAPARIB AND DOSTARLIMAB IN PAEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMOURS

  • IRAS ID

    289778

  • Contact name

    Negin Hashemi

  • Contact email

    negin.x.hashemi@gsk.com

  • Sponsor organisation

    GlaxoSmithKline Research & Development Limited

  • Eudract number

    2020-002359-39

  • ISRCTN Number

    ISRCTN00000000

  • Clinicaltrials.gov Identifier

    NCT00000000

  • Duration of Study in the UK

    8 years, 3 months, 1 days

  • Research summary

    Childhood cancers are a leading cause of death in children globally, with approximately 300,000 cancers diagnosed per year and an estimated 80,000 cancer-related deaths in children per year worldwide. For patients whose cancers do not respond adequately to frontline treatments or those whose cancers come back despite treatment, there is a pressing need for new treatments.

    The main purpose of the research study is:
    •To evaluate the safest and best doses of the combination of two study drugs niraparib and dostarlimab in children and adolescents with refractory and recurrent solid tumours and
    •To establish whether the combination of the two study drugs can increase the body’s ability to fight the cancer cells and cause the tumours to respond by stabilising or shrinking.

    This study has 4 Parts (Part 1a/b, and Part 2a/b). The participants will be enrolled into one of the 4 parts depending on which part is ongoing, the type of solid tumour the participant has, the participant’s weight and ability to swallow (pills or liquid).

    Niraparib is available as a pill or as a liquid taken by mouth. Dostarlimab is available as an infusion for intravenous use, ie injection into a vein.

    Participants in this study will receive the study drugs as follows:
    Part 1a – Niraparib pill(s) given by mouth daily plus dostarlimab given every 3 weeks by a vein.
    Part 1b – Niraparib liquid or pill (s) given by mouth daily plus dostarlimab given every 3 weeks by a vein. Dose will be determined from Part 1a.
    Part 2a and Part 2b (for participants with osteosarcoma or neuroblastoma) – Niraparib liquid or pills given by mouth daily plus dostarlimab given every 3 weeks via a vein. Dose will be determined from Part 1a and Part 1b groups.

    This is an open label study meaning that both the participants and the study doctor will know which drugs are given to the participants(there is no ‘blinding’ or placebo/’dummy drug’). This study will include about 116 children and adolescents (about 32 in Part 1A, 24 in Part 1B and 30 each in Part 2A and Part 2B, depending on number of dose levels required, and side effects.

  • REC name

    London - Hampstead Research Ethics Committee

  • REC reference

    21/LO/0307

  • Date of REC Opinion

    25 Jun 2021

  • REC opinion

    Further Information Favourable Opinion