- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07652515
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer
11. juni 2026 opdateret af: GlaxoSmithKline
Phase 4, Open Label, Single-arm, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Primary Advanced or Recurrent Endometrial Cancer
This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
Undersøgelse Kontakt Backup
- Navn: EU GSK Clinical Trials Call Center
- Telefonnummer: +44 (0) 20 89904466
- E-mail: GSKClinicalSupportHD@gsk.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Participant with greater than or equals to (>=) 18 years of age, at the time of signing the informed consent.
- Participant has histologically or cytologically proven EC with recurrent or advanced disease.
- Participant must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination based on investigator's assessment.
- Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
- Woman of childbearing potential (WOCBP) agrees to use contraceptive from screening through at least 180 days after the last dose.
- Negative urine pregnancy test at most 24 hours prior to the first dose of study intervention.
- Capable of giving signed informed consent.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- Participant has had greater than (>) 1 recurrence of endometrial cancer.
- Participant has a concomitant malignancy, or participant has a prior non endometrial invasive malignancy who has been disease-free for less than (<) 3 years or who received any active treatment in the last 3 years for that malignancy.
- Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
- Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.
- Participant has not recovered (i.e., to Grade less than or equal to [<=] 1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony-stimulating factor [G-CSF], Granulocyte macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within 21 days prior to the first dose of study drug.
- Either the history of hypersensitivity to excipients of the study intervention or to drugs with a similar chemical structure or class of the study intervention.
- 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 has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:
- has not had a recurrence or Progressive disease (PD) prior to first dose on the study, or
- has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study.
- Participant has received prior therapy with an anti- Programmed death protein 1 (anti-PD-1), anti- Programmed death ligand 1 (anti-PD-L1), or Programmed death ligand 2 (anti PD L2) agent.
- Participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days or <5 times the half life of the most recent therapy prior to study Day 1, whichever is shorter.
- Systemic glucocorticoids for any purpose other than to manage symptoms of suspected irAEs. If medically deemed necessary (e.g., acute asthma or chronic obstructive pulmonary disease exacerbation, prophylaxis for intravenous (IV) contrast if indicated), Investigators are allowed to use their judgment to treat participants with systemic steroids. In such cases, systemic steroids should be stopped at least 24 hours prior to the next dose of study treatment.
- Participant has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study intervention, during study treatment, and for up to 180 days after receiving the last dose of study intervention.
- Participant has a diagnosis of immunodeficiency and is receiving systemic steroid therapy (>10 milligrams [mg] daily prednisone or equivalent) within 7 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication.
- Participant is currently receiving study intervention, or is enrolled or has participated in any other clinical study involving an investigational intervention and received investigational treatment or used an investigational device within 4 weeks of the first dose of dostarlimab.
- Participant is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study intervention.
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy
Participants will receive dose level 1 of dostarlimab in combination with carboplatin and paclitaxel followed by dose level 2 of dostarlimab monotherapy.
Dose level 1 is the lowest dose level.
|
Dostarlimab vil blive administreret.
Carboplatin vil blive administreret.
Paclitaxel administreres.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49
Tidsramme: Up to Week 49
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Up to Week 49
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of participants with Grade 3 or greater TEAEs up to Week 170
Tidsramme: Up to Week 170
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Up to Week 170
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Number of participants with TEAEs up to Week 49
Tidsramme: Up to Week 49
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Up to Week 49
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Number of participants with TEAEs up to Week 170
Tidsramme: Up to Week 170
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Up to Week 170
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Number of participants with Immune-related adverse events (irAEs) up to Week 49
Tidsramme: Up to Week 49
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Up to Week 49
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Number of participants with Immune-related adverse events (irAEs) up to Week 170
Tidsramme: Up to Week 170
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Up to Week 170
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Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, fatal AEs, non-fatal SAEs up to Week 49
Tidsramme: Up to Week 49
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Up to Week 49
|
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Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, fatal AEs, non-fatal SAEs up to Week 170
Tidsramme: Up to Week 170
|
Up to Week 170
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Number of Participants with AEs leading to discontinuation of treatment, AEs leading to study withdrawal and AEs leading to dose modification up to Week 49
Tidsramme: Up to Week 49
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Up to Week 49
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Number of Participants with AEs leading to discontinuation of treatment, AEs leading to study withdrawal and AEs leading to dose modification up to Week 170
Tidsramme: Up to Week 170
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Up to Week 170
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Change from Baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 49
Tidsramme: Baseline (Day 1) and up to 49
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Baseline (Day 1) and up to 49
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Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) to up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose, calcium, sodium, and potassium levels (Millimoles per Liter) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose, calcium, sodium, and potassium levels (Millimoles per Liter) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in clinical chemistry parameters: Total protein levels (Gram per liter) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in clinical chemistry parameters: Total protein levels (Gram per liter) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 49
Tidsramme: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 170
Tidsramme: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: GSK Clinical Trials, GlaxoSmithKline
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
17. august 2026
Primær færdiggørelse (Anslået)
30. august 2030
Studieafslutning (Anslået)
30. august 2030
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
11. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Genitale neoplasmer, kvindelige
- Uterine neoplasmer
- Endometriale neoplasmer
- Organiske kemikalier
- Kulbrinter
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Koordinationskomplekser
- Taxoider
- Cyclodecanes
- Diterpenes
- Carboplatin
- Paclitaxel
- Dostarlimab
Andre undersøgelses-id-numre
- 309169
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents.
Data sharing is subject to certain criteria, conditions, and exceptions.
For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
IPD-delingstidsramme
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD-delingsadgangskriterier
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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