Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Pediatric Participants With Solid Tumors (SCOOP)
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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 : November 22, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasms | Drug: Niraparib Drug: Dostarlimab | Phase 1 |
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 and dostarlimab will be determined in participants with recurrent or refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, Ewing sarcoma,or rhabdomyosarcoma, or any other solid tumor (excluding tumors of the central nervous system [CNS]) with a previously documented BRCAness mutational signature. Part 1 will be followed by Part 2 (dose expansion 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 : | September 28, 2028 |
Estimated Study Completion Date : | April 12, 2029 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1A: Dose Escalation
Participants with body weight of ≥ 20 kilogram (kg) and who can swallow niraparib tablets will receive niraparib tablets and dostarlimab.
|
Drug: Niraparib
Niraparib will be administered as tablet Drug: Dostarlimab Dostarlimab will be administered as IV infusion |
Experimental: Part 1B: Dose Escalation
Participants who are not able to swallow niraparib tablets or who have a body weight of <20 kg will receive niraparib age-appropriate oral liquid formulation (AAOLF) (once available) and dostarlimab.
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Drug: Dostarlimab
Dostarlimab will be administered as IV infusion Drug: Niraparib Niraparib will be administered as AAOLF (once available) |
Experimental: Part 2A: Cohort Expansion for Osteosarcoma
Participants with osteosarcoma who are not able to swallow niraparib tablets or have a body weight of < 20 kg, will receive the RP2D of niraparib AAOLF (when available) and dostarlimab. Participants with osteosarcoma who are able to swallow niraparib tablets and have a body weight ≥20 kg will receive the RP2D of niraparib tablets and dostarlimab.
|
Drug: Niraparib
Niraparib will be administered as tablet Drug: Dostarlimab Dostarlimab will be administered as IV infusion Drug: Niraparib Niraparib will be administered as AAOLF (once available) |
Experimental: Part 2B: Cohort Expansion for Neuroblastoma
Participants with neuroblastoma who are not able to swallow niraparib tablets or who have a body weight of <20 kg will receive the RP2D of niraparib AAOLF (when available) and dostarlimab. Participants with neuroblastoma who are able to swallow niraparib tablets and have a body weight of ≥ 20 kg, will receive the RP2D of niraparib tablets and dostarlimab, when available. |
Drug: Niraparib
Niraparib will be administered as tablet Drug: Dostarlimab Dostarlimab will be administered as IV infusion Drug: Niraparib Niraparib will be administered as AAOLF (once available) |
- Part 1A: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 42 days ]Number of participants with DLTs will be reported.
- Part 1B: Number of participants with DLTs [ Time Frame: Up to 42 days ]Number of participants with DLTs will be reported.
- Part 2A: Progression-free survival rate at 6 months (PFS6) in participants with osteosarcoma [ Time Frame: Up to 6 months ]PFS6 is defined as the proportion 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.
- Part 2B: Objective response rate (ORR) in participants with neuroblastoma [ Time Frame: Up to 2 years ]ORR is defined as the proportion 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).
- Part 1A, Part 1B and Part 2A: ORR [ Time Frame: Up to 2 years ]ORR is defined as the proportion of participants with a BOR of confirmed CR or PR as determined by the Investigator using RECIST v1.1 criteria.
- Part 1A, Part 1B and Part 2A: Duration of response (DOR) [ Time Frame: Up to 2 years ]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).
- Part 2B: DOR [ Time Frame: Up to 2 years ]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).
- Part 1A, Part 1B and Part 2A: Disease control rate (DCR) in participants [ Time Frame: Up to 2 years ]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.
- Part 2B: DCR [ Time Frame: Up to 2 years ]DCR is defined as the proportion of participants who have achieved a BOR of confirmed CR, confirmed PR, or stable disease by INRC based on Investigator assessment.
- Part 2A: PFS [ Time Frame: Up to 2 years ]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).
- Part 2B: PFS [ Time Frame: Up to 2 years ]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).
- Part 1A, Part 1B, Part 2A and Part 2B: Number of participants with Treatment emergent adverse events (TEAEs), adverse events (AEs, Serious AEs (SAEs), immune-related AEs (irAEs), TEAEs leading to death and AEs leading to discontinuation [ Time Frame: Up to 5 years ]TEAEs, AEs, SAEs, irAEs, TEAEs leading to death and AEs leading to discontinuation will be collected.
- Part 1A, Part 1B, Part 2A and Part 2B: Plasma concentration of niraparib [ Time Frame: Up to Week 2 ]Blood samples will be collected for the concentrations of niraparib.
- Part 1A, Part 1B, Part 2A and Part 2B: Serum concentration of dostarlimab [ Time Frame: Up to 2 years ]Blood samples will be collected for the concentrations of dostarlimab
- Part 1A, Part 1B, Part 2A and Part 2B: Number of subjects with positive ADAs against dostarlimab [ Time Frame: Up to 2 years ]
- Part 1A, Part 1B, Part 2A and Part 2B: Titers of neutralizing anti-bodies to dostarlimab [ Time Frame: Up to 2 years ]
- Part 1A, Part 1B, Part 2A and Part 2B: Acceptability and Palatability questionnaire score in pediatric participants [ Time Frame: Day 1 ]Acceptability and Palatability of niraparib as tablets and as AAOLF will be assessed using the acceptability and palatability questionnaires

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Ages Eligible for Study: | 6 Months to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- Participant with disease other than neuroblastoma has radiologically measurable disease that can be tracked as RECIST v1.1. Participant with neuroblastoma has measurable/evaluable disease by INRC at the time of study enrolment. Neuroblastoma participants with recurrent/relapsed bone metastasis that is MIBG-positive (or FDG-PET positive, for MIBG-nonavid tumors) as only site of disease are eligible.
- Participant will receive niraparib tablet or age-appropriate oral liquid formulation based on body weight and ability to swallow tablet.
- Performance status must be >=60 percent on the Karnofsky scale for participants >16 years of age and >=60 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]) and must not be eligible for local curative treatment: Participants with non-CNS solid tumours other than osteosarcoma, neuroblastoma, adrenocortical carcinoma, Ewing sarcoma or rhabdomyosarcoma are required to have prior documented 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 of Cycle 1 Day 1. 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 and BRCA 2 and other homologous recombination DNA repair (HRR) pathway genes, mutational signatures including mutational signature 3, and tumor mutational burden (TMB).
For Part 2A (osteosarcoma expansion cohort) only:
- Participant has recurrent or refractory osteosarcoma and must not be eligible for local curative treatment. Documentation of BRCAness mutational signature 3 will be requested, but not required, for enrollment.
- Participant has radiographically measurable disease that can be tracked as RECIST v1.1 target lesion(s).
- Participant must confirm at screening that an archival or fresh tumor tissue sample is available for use, in retrospective exploratory biomarker analysis. Otherwise, enrolling site must discuss with Sponsor.
For Part 2B (neuroblastoma expansion cohort) only:
- Participant has recurrent or refractory neuroblastoma and must not be eligible for local curative treatment. Documentation of BRCAness mutational signature 3 will be requested, but not required, for enrollment.
- Participant has measurable/ evaluable disease by INRC at the time of study enrollment. Participants with recurrent/relapsed bone metastasis that is metaiodobenzylguanidine-positive (or FDG-PET positive, for MIBG nonavid tumors) as only site of disease are eligible.
- Participant must confirm at screening that an archival or fresh tumor tissue sample is available for use, in retrospective exploratory biomarker analysis. Otherwise, enrolling site must discuss with Sponsor.
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 (that is [i.e.], with use of disease-modifying anti-rheumatic drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (for example [e.g.], 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.
- 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 treatment.
- Participant has a known history of human immunodeficiency virus (HIV) (type 1 or 2 antibodies).
- Participant has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative] is detected).
- Participant must not have a gastrointestinal condition, such as bowel obstruction, that can impact absorption of oral medications and is identified by clinical symptoms or CT scan, etc.
- Participant has had any known Grade 3 or 4 anemia, neutropenia, and/or thrombocytopenia that was related to the most recent prior anti-cancer treatment and that persisted >4 weeks.
- Participant had toxicity related to prior immunotherapy that led to study treatment discontinuation.
- Participant had treatment with systemic anticancer therapy (investigational agent or device, or approved chemotherapy, targeted therapy, immunotherapy, or other systemic therapy) within 3 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study treatment, radiation therapy encompassing >20 percent of the bone marrow within 2 weeks prior to the first dose of study treatment, or any radiation therapy within 1 week prior to the first dose of study treatment.
- Participant has not recovered adequately from AEs or complications from any major surgery prior to starting study treatment.
- Participant has received a live vaccine within 30 days of planned start of study treatment.
- Participant has clinically significant cardiovascular disease (e.g., 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 at screening >450 milliseconds (msec) or >480 msec for participants with bundle branch block.
- Participant has received a solid organ transplant.
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).

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
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 |
Czechia | |
GSK Investigational Site | Recruiting |
Brno, Czechia, 62500 | |
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: Jaroslav Sterba | |
GSK Investigational Site | Recruiting |
Prague, Czechia, 150 06 | |
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: David Sumerauer | |
France | |
GSK Investigational Site | Recruiting |
Lille, France, 59000 | |
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: Sandra Raimbault | |
GSK Investigational Site | Recruiting |
Lyon, France, 69008 | |
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: Nadège Corradini | |
GSK Investigational Site | Recruiting |
Marseille, France, 13005 | |
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: Nicolas André | |
GSK Investigational Site | Recruiting |
Paris cedex 05, France, 75248 | |
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: François Doz | |
GSK Investigational Site | Recruiting |
Paris, France, 75012 | |
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: Arnaud Petit | |
GSK Investigational Site | Recruiting |
Villejuif, France, 94805 | |
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: Birgit Geoerger | |
Germany | |
GSK Investigational Site | Recruiting |
Heidelberg, Baden-Wuerttemberg, Germany, 69120 | |
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: Kristian W. Pajtler | |
GSK Investigational Site | Recruiting |
Muenchen, Bayern, Germany, 80804 | |
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: Irene Teichert-von Luettichau | |
GSK Investigational Site | Recruiting |
Frankfurt am Main, Hessen, Germany, 60590 | |
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: Martina Becker | |
GSK Investigational Site | Recruiting |
Essen, Nordrhein-Westfalen, Germany, 45122 | |
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: Uta Dirksen | |
GSK Investigational Site | Recruiting |
Hamburg, Germany, 20246 | |
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: Uwe Kordes | |
Hungary | |
GSK Investigational Site | Recruiting |
Budapest, Hungary, 1094 | |
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: Gyoergy Fekete | |
Spain | |
GSK Investigational Site | Recruiting |
Barcelona, Spain, 08035 | |
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 | |
GSK Investigational Site | Recruiting |
Esplugues De Llobregat. Barcelona, Spain, 08950 | |
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: Jaume Mora Graupera | |
GSK Investigational Site | Recruiting |
Madrid, Spain, 28009 | |
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: Alba Rubio San Simón | |
GSK Investigational Site | Recruiting |
Madrid, Spain, 28046 | |
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: Pilar Guerra Garcia | |
GSK Investigational Site | Recruiting |
Valencia, Spain, 46026 | |
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: Antonio Juan Ribelles | |
United Kingdom | |
GSK Investigational Site | Recruiting |
Glasgow, United Kingdom, G51 4TF | |
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: Milind Ronghe | |
GSK Investigational Site | Recruiting |
London, United Kingdom, NW1 2PG | |
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: Sandra Strauss |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT04544995 |
Other Study ID Numbers: |
213406 2020-002359-39 ( EudraCT Number ) |
First Posted: | September 10, 2020 Key Record Dates |
Last Update Posted: | November 22, 2022 |
Last Verified: | November 2022 |
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 |
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 |
Dose escalation Dose Expansion Dostarlimab |
Niraparib Osteosarcoma Neuroblastoma |
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