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Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Pediatric Participants With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04544995
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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 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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Niraparib Tablet Drug: Niraparib AAOLF Drug: Dostarlimab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: In Part 1 (dose escalation phase), the RP2D of the combination of niraparib tablets and dostarlimab (Part 1A) as well as the RP2D of the combination of niraparib age-appropriate oral liquid formulation (AAOLF) and dostarlimab (Part 1B) 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 in disease-specific expansion cohorts (osteosarcoma and neuroblastoma).
Masking: None (Open Label)
Masking Description: This will be an open-label study.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 6, 2020
Estimated Primary Completion Date : February 5, 2030
Estimated Study Completion Date : July 23, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1A: Dose escalation phase: Niraparib tablet+ Dostarlimab
In Part 1A, participants will receive niraparib tablet in combination with dostarlimab. Up to 4 dose-level cohorts are planned and the starting dose of niraparib tablet will be 100 milligrams (mg) daily. Additional dose levels will be determined with consideration to comprehensive safety data and exposure data from population PK. The dostarlimab starting dose will be 3 milligrams per kilograms (mg/kg), administered every 3 weeks with possible escalation to 7.5 mg/kg (with maximum dose of 500 mg) or de-escalation to 1 mg/kg.
Drug: Niraparib Tablet
Niraparib tablets will be available with a unit dose of 100 mg to be given orally.

Drug: Dostarlimab
Dostarlimab will be available as solution for intravenous (IV) infusion in single-use vial with a unit dose of 50 milligrams per milliliter (mg/mL).

Experimental: Part 1B: Dose escalation phase: Niraparib AAOLF + Dostarlimab
In Part 1B, participants will receive niraparib AAOLF in combination with dostarlimab. Up to 3 dose-level cohorts are planned and the starting dose level for niraparib AAOLF will be determined by population PK modelling using the RP2D from Part 1A. The starting dose level for dostarlimab will be the RP2D as determined from Part 1A.
Drug: Niraparib AAOLF
Niraparib AAOLF will be given to the eligible participants during the study. The starting dose level for niraparib AAOLF will be determined by population PK modelling using the RP2D from Part 1A.

Drug: Dostarlimab
Dostarlimab will be available as solution for intravenous (IV) infusion in single-use vial with a unit dose of 50 milligrams per milliliter (mg/mL).

Experimental: Part 2: DE phase: Participants with osteosarcoma (tablets)
In Part 2, participants with osteosarcoma who are able to swallow tablets and weigh >=20 kg will be eligible to receive the RP2D of niraparib along with dostarlimab once the RP2D for the niraparib tablets or dostarlimab is determined in Part 1A of the study.
Drug: Niraparib Tablet
Niraparib tablets will be available with a unit dose of 100 mg to be given orally.

Drug: Dostarlimab
Dostarlimab will be available as solution for intravenous (IV) infusion in single-use vial with a unit dose of 50 milligrams per milliliter (mg/mL).

Experimental: Part 2: DE phase: Participants with osteosarcoma (AAOLF)
In Part 2, participants with osteosarcoma who are not able to swallow tablets or weigh <20 kg will be eligible to receive the RP2D of niraparib AAOLF with dostarlimab once the RP2D for the niraparib AAOLF and dostarlimab is determined in Part 1B of the study.
Drug: Niraparib AAOLF
Niraparib AAOLF will be given to the eligible participants during the study. The starting dose level for niraparib AAOLF will be determined by population PK modelling using the RP2D from Part 1A.

Drug: Dostarlimab
Dostarlimab will be available as solution for intravenous (IV) infusion in single-use vial with a unit dose of 50 milligrams per milliliter (mg/mL).

Experimental: Part 2: DE phase: Participants with neuroblastoma (tablet)
In Part 2, participants with neuroblastoma who are able to swallow tablets and weigh >=20 kg will be eligible to receive the RP2D of niraparib along with dostarlimab once the RP2D for the niraparib tablets and dostarlimab is determined in Part 1A of the study.
Drug: Niraparib Tablet
Niraparib tablets will be available with a unit dose of 100 mg to be given orally.

Drug: Dostarlimab
Dostarlimab will be available as solution for intravenous (IV) infusion in single-use vial with a unit dose of 50 milligrams per milliliter (mg/mL).

Experimental: Part 2: DE phase: Participants with neuroblastoma (AAOLF)
In Part 2, participants with neuroblastoma who are not able to swallow tablets or weigh <20 kg will be eligible to receive the RP2D of niraparib AAOLF with dostarlimab once the RP2D for the niraparib AAOLF and dostarlimab is determined in Part 1B of the study.
Drug: Niraparib AAOLF
Niraparib AAOLF will be given to the eligible participants during the study. The starting dose level for niraparib AAOLF will be determined by population PK modelling using the RP2D from Part 1A.

Drug: Dostarlimab
Dostarlimab will be available as solution for intravenous (IV) infusion in single-use vial with a unit dose of 50 milligrams per milliliter (mg/mL).




Primary Outcome Measures :
  1. Part 1A: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 42 days from start of the treatment (Day 0) ]
    An event is considered to be a DLT if the event occurs within the first 42 days of treatment and meets protocol defined DLT criteria. Number of participants with DLTs will be reported.

  2. Part 1B: Number of participants with DLTs [ Time Frame: Up to 42 days from start of the treatment (Day 0) ]
    An event is considered to be a DLT if the event occurs within the first 42 days of treatment and meets protocol defined DLT criteria. Number of participants with DLTs will be reported.

  3. Part 2: Progression-free survival rate at 6 months (PFS6) in participants with osteosarcoma [ Time Frame: Up to 6 months from start of the treatment (Day 0) ]
    PFS6 is defined as the percentage of participants without progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria or death at 6 months from the date of the first dose of study treatment.

  4. Part 2: Overall response rate (ORR) in participants with neuroblastoma [ Time Frame: Up to 6 months from start of the treatment (Day 0) ]
    ORR is defined as the percentage of participants who have a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Investigator using International Neuroblastoma Response Criteria (INRC).


Secondary Outcome Measures :
  1. Part 1A and Part 1B: ORR [ Time Frame: Up to 6 months from start of the treatment (Day 0) ]
    ORR based on Investigator assessment is defined as the percentage of participants with a BOR of confirmed CR or PR as determined by the Investigator using RECIST v1.1 criteria or INRC (for participants with neuroblastoma only).

  2. Part 1A and Part 1B: Duration of response (DOR) [ Time Frame: Up to 6 months ]
    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).

  3. Part 2: ORR in participants with osteosarcoma [ Time Frame: Up to 6 months from start of the treatment (Day 0) ]
    ORR is defined as the percentage of participants who have a BOR of confirmed CR or PR as determined by the Investigator using RECIST v1.1.

  4. Part 2: DOR in participants with osteosarcoma [ Time Frame: Up to 6 months ]
    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 based on Investigator assessment or death (whichever occurs first).

  5. Part 2: Disease control rate (DCR) in participants with osteosarcoma [ Time Frame: Up to 6 months from start of the treatment (Day 0) ]
    DCR is defined as the percentage of participants who have achieved a BOR of confirmed CR, confirmed PR, or stable disease by RECIST v1.1 based on Investigator assessment.

  6. Part 2: PFS in participants with osteosarcoma [ Time Frame: Up to 6 months from start of the treatment (Day 0) ]
    PFS is defined as the time from the date of the first dose of study treatment to the first documented PD, as determined by RECIST v1.1 based on Investigator assessment, or death from any cause (whichever occurs first).

  7. Part 2: DOR in participants with neuroblastoma [ Time Frame: Up to 6 months ]
    DOR is defined as the time from first documentation of response (CR or PR) until the time of first documented PD by INRC based on Investigator assessment or death (whichever occurs first).

  8. Part 2: DCR in participants with neuroblastoma [ Time Frame: Up to 6 months from start of the treatment (Day 0) ]
    DCR is defined as the percentage of participants who have achieved a BOR of confirmed CR, confirmed PR, or stable disease by INRC based on Investigator assessment.

  9. Part 2: PFS in participants with neuroblastoma [ Time Frame: Up to 6 months from start of the treatment (Day 0) ]
    PFS is defined as the time from the date of the first dose of study treatment to the first documented PD as determined by INRC based on Investigator assessment, or death from any cause (whichever occurs first).

  10. Part 1A and Part 1B: Number of participants with adverse events (AEs), Serious AEs (SAEs), immune-related AEs (irAEs), AEs leading to death, AEs leading to discontinuation [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any SAE that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect or any other situations as per Medical or scientific judgment. Number of participants with AEs, SAEs, irAEs, AEs leading to death, and AEs leading to discontinuation will be summarized.

  11. Part 1A and Part 1B: Plasma concentration of niraparib [ Time Frame: Cycle 1 Week 2 (Cycle duration: 21 days) ]
    Blood samples will be collected at indicated time points to analyze plasma concentration of niraparib.

  12. Part 1A and Part 1B: Serum concentration of dostarlimab [ Time Frame: Cycle 1, 3, 4, 6 and every 6 cycles thereafter (Up to maximum 2 years) (Each Cycle of 21 days) ]
    Blood samples will be collected at indicated time points to analyze serum concentration of dostarlimab.

  13. Part 1A: Number of participants compliant based on 'Acceptability and Palatability questionnaire' [ Time Frame: Cycle 1 Week 1 (Cycle duration: 21 days) ]
    The Acceptability and Palatability questionnaire addresses and intends to collect information on the 100 mg niraparib tablet formulation. Acceptability of niraparib tablets is defined based on overall experience of participants swallowing the tablet. Participants will select appropriate reasons from following such as due to taste, size, shape, color, medical condition or any other reason in cases where the tablet is unable to be swallowed.

  14. Part 2: Number of participants with AEs, SAEs, irAEs, AEs leading to death, AEs leading to discontinuation in participants with osteosarcoma [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any SAE that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect or any other situations as per Medical or scientific judgment. Number of participants with AEs, SAEs, irAEs, AEs leading to death, and AEs leading to discontinuation will be summarized.

  15. Part 2: Plasma concentration of niraparib in participants with osteosarcoma [ Time Frame: Cycle 1 Week 2 (Cycle duration: 21 days) ]
    Blood samples will be collected at indicated time points to analyze plasma concentration of niraparib.

  16. Part 2: Serum concentration of dostarlimab in participants with osteosarcoma [ Time Frame: Cycle 1, 3, 4, 6 and every 6 cycles thereafter (Up to maximum 2 years) (Each Cycle of 21 days) ]
    Blood samples will be collected at indicated time points to analyze serum concentration of dostarlimab.

  17. Part 2: Number of participants compliant based on 'Acceptability and Palatability questionnaire' in participants with osteosarcoma [ Time Frame: Cycle 1 Week 1 (Cycle duration: 21 days) ]
    The Acceptability and Palatability questionnaire addresses and intends to collect information on the 100 mg niraparib tablet formulation. Acceptability of niraparib tablets is defined based on overall experience of participants swallowing the tablet. Participants will select appropriate reasons from following such as due to taste, size, shape, color, medical condition or any other reason in cases where the tablet is unable to be swallowed.

  18. Part 2: Number of participants with AEs, SAEs, irAEs, AEs leading to death, AEs leading to discontinuation in participants with neuroblastoma [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any SAE that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect or any other situations as per Medical or scientific judgment. Number of participants with AEs, SAEs, irAEs, AEs leading to death, and AEs leading to discontinuation will be summarized.

  19. Part 2: Plasma concentration of niraparib in participants with neuroblastoma [ Time Frame: Cycle 1 Week 2 (Cycle duration: 21 days) ]
    Blood samples will be collected at indicated time points to analyze plasma concentration of niraparib.

  20. Part 2: Serum concentration of dostarlimab in participants with neuroblastoma [ Time Frame: Cycle 1, 3, 4, 6 and every 6 cycles thereafter (Up to maximum 2 years) (Each Cycle of 21 days) ]
    Blood samples will be collected at indicated time points to analyze serum concentration of dostarlimab.

  21. Part 2: Number of participants compliant based on 'Acceptability and Palatability questionnaire' in participants with neuroblastoma [ Time Frame: Cycle 1 Week 1(Cycle duration: 21 days) ]
    The Acceptability and Palatability questionnaire addresses and intends to collect information on the 100 mg niraparib tablet formulation. Acceptability of niraparib tablets is defined based on overall experience of participants swallowing the tablet and parent's or caregiver's observation on the result of the intake if not swallowed. Participants will have to select appropriate reasons from following in cases where the tablet is unable to be swallowed such as due to taste, size, shape, color, medical condition or any other reason.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For Part 1 and Part 2 (osteosarcoma and neuroblastoma expansion cohorts):

  • Participant is a child or an adolescent greater than or equal to (>=) 6 months to less than (<) 18 years old at the time of informed consent/assent.
  • In order to be eligible to receive the niraparib tablet formulation, participant must be able to swallow the 100 mg niraparib tablet and have a body weight of >=20 kg. Participants who are unable to swallow the 100 mg niraparib tablet or who have a body weight <20 kg are eligible to receive the niraparib AAOLF only.
  • Performance status must be >=70 percent on the Karnofsky scale for participants >16 years of age and >=50 percent on the Lansky scale for participants less than or equal to (<=) 16 years of age.
  • Participant has adequate organ function.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective.
  • A male participant of reproductive potential is eligible to participate if he agrees to refrain from donating sperm PLUS, either be abstinent from heterosexual intercourse OR must agree to use a male condom.

For Part 1 only:

  • Participant has recurrent or refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, Ewing sarcoma, rhabdomyosarcoma, or any other solid tumor (excluding tumors of the central nervous system [CNS]) previously documented to have breast cancer susceptibility gene (BRCAness) mutational signature (mutational signature 3) on deoxyribonucleic acid (DNA) sequencing of tumor obtained in the relapsed/recurrent disease setting, within 6 (preferably 3) months prior to enrolment. For participants with documented BRCAness mutational signature: Existing information on molecular profiling of the participant's tumor tissue must be through a molecular profiling platform such as Individualized Therapy for Relapsed Malignancies in Childhood (INFORM). Molecular profile information must contain information from whole exome sequencing or whole genome sequencing, including the mutation status of BRCA1/2 and other homologous recombination DNA repair (HRR) pathway genes, mutational signatures including signature 3, and tumor mutational burden (TMB).

For Part 2 (osteosarcoma expansion cohort) only:

  • Participant has recurrent or refractory osteosarcoma.
  • Participant has radiographically measurable disease that can be tracked as RECIST v1.1 target lesion(s).
  • Participant must provide tumor tissue sample at screening for retrospective exploratory biomarker analysis.

For Part 2 (neuroblastoma expansion cohort) only:

  • Participant has recurrent or refractory neuroblastoma.
  • Participant has radiographically measurable disease at the time of study enrolment; participants with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine-positive (+) evaluable disease are eligible. Measurable disease in participants with CNS involvement is defined as a tumor that is measurable in 2 perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than 1 slice.
  • Participant must provide tumor tissue sample at screening.

Exclusion Criteria:

For Part 1 and Part 2 (osteosarcoma and neuroblastoma expansion cohorts):

  • Participant has known hypersensitivity to dostarlimab or niraparib, their components, or their excipients.
  • Participant has a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Participant has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying anti-rheumatic drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Participant has known active CNS metastases, carcinomatous meningitis, or both. Carcinomatous meningitis precludes a participant from study participation regardless of clinical stability.
  • Participant had a known additional malignancy that progressed or required active treatment within the last 2 years.
  • Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection that requires systemic therapy.
  • Participant has a condition (such as transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the participant's participation for the full duration of the study treatment including the following: Participants who received a transfusion (platelets or red blood cells) within 6 weeks of the first dose of study drug are not eligible. Participants who received colony-stimulating factors (eg, granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior to the first dose of study drug are not eligible.
  • Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Participant has a known history of human immunodeficiency virus (HIV) (type 1 or 2 antibodies).
  • Participant has known active hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] is detected).
  • Participant has had any known Grade 3 or 4 anemia, neutropenia, or thrombocytopenia due to prior chemotherapy that persisted >4 weeks related to the most recent prior treatment.
  • Participant had treatment with prior systemic anticancer therapy within the 3 weeks prior to the first dose of study drug, radiation therapy encompassing >20 percent of the bone marrow within 2 weeks prior to the first dose of study drug, or any radiation therapy within 1 week prior to the first dose of study drug.
  • Participant has received a live vaccine within 14 days of planned start of study drug.
  • Participant has clinically significant cardiovascular disease (eg, significant cardiac conduction abnormalities, uncontrolled hypertension, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, and history of cerebrovascular accident) within 6 months of enrolment.
  • Participant has heart rate-corrected QT interval prolongation >480 milliseconds at screening. The participant may be eligible to participate in the study following discussion with the Sponsor's Medical Monitor.

For Part 2 (osteosarcoma expansion cohort and neuroblastoma expansion cohort):

  • Participant has received prior therapy with an anti-PD-1, anti-programmed cell death ligand 1, anti-programmed cell death-ligand 2, anti-cytotoxic T-lymphocyte-associated antigen-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (with the exception of participants rolling over from Part 1 of the study: these participants are allowed to have received dostarlimab).
  • Participant has had prior treatment with a known poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor (with the exception of participants rolling over from Part 1 of the study: these participants are allowed to have received niraparib).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544995


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Spain
GSK Investigational Site Recruiting
Barcelona, Madrid, Spain, 8035
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Lucas Moreno Martin         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04544995    
Other Study ID Numbers: 213406
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by GlaxoSmithKline:
Dose escalation
Dostarlimab
Niraparib
Osteosarcoma
Neuroblastoma
Additional relevant MeSH terms:
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Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents