Solid Tumours
Conditions
Brief summary
Part 1A and 1B: Assess the incidence of DLTs by study part and cohort for the DLT-evaluable population to establish the RP2D of the combination of niraparib (both tablet in Part 1a and TfOS in Part 1b) and dostarlimab. Part 2: Please refer to the separate cohort-specific supplements for this information.
Detailed description
• ORR based on Investigator assessment is defined as the proportion of participants with a BOR of confirmed CR or PR as determined by the Investigator using RECIST v1.1 or INRC (for participants with neuroblastoma only)., • DOR is defined as the time from first documentation of response (CR or PR) until the time of first documented PD by RECIST v1.1 or INRC (for participants with neuroblastoma only) based on Investigator assessment or death (whichever occurs first)., Part 1: Please refer to main study protocol for further Endpoints Part 2: Please refer to the separate cohort-specific supplements for this information.
Interventions
DRUGJEMPERLI 500 mg concentrate for solution for infusion
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1A and 1B: Assess the incidence of DLTs by study part and cohort for the DLT-evaluable population to establish the RP2D of the combination of niraparib (both tablet in Part 1a and TfOS in Part 1b) and dostarlimab. Part 2: Please refer to the separate cohort-specific supplements for this information. | — |
Secondary
| Measure | Time frame |
|---|---|
| • ORR based on Investigator assessment is defined as the proportion of participants with a BOR of confirmed CR or PR as determined by the Investigator using RECIST v1.1 or INRC (for participants with neuroblastoma only)., • DOR is defined as the time from first documentation of response (CR or PR) until the time of first documented PD by RECIST v1.1 or INRC (for participants with neuroblastoma only) based on Investigator assessment or death (whichever occurs first)., Part 1: Please refer to main study protocol for further Endpoints Part 2: Please refer to the separate cohort-specific supplements for this information. | — |
Countries
Czechia, France, Germany, Hungary, Spain
Outcome results
None listed