- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07652515
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer
11. června 2026 aktualizováno: 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).
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
100
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: US GSK Clinical Trials Call Center
- Telefonní číslo: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
Studijní záloha kontaktů
- Jméno: EU GSK Clinical Trials Call Center
- Telefonní číslo: +44 (0) 20 89904466
- E-mail: GSKClinicalSupportHD@gsk.com
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
Bude podáván dostarlimab.
Bude podávána karboplatina.
PACLITAXEL bude podáván.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49
Časové okno: Up to Week 49
|
Up to Week 49
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Number of participants with Grade 3 or greater TEAEs up to Week 170
Časové okno: Up to Week 170
|
Up to Week 170
|
|
Number of participants with TEAEs up to Week 49
Časové okno: Up to Week 49
|
Up to Week 49
|
|
Number of participants with TEAEs up to Week 170
Časové okno: Up to Week 170
|
Up to Week 170
|
|
Number of participants with Immune-related adverse events (irAEs) up to Week 49
Časové okno: Up to Week 49
|
Up to Week 49
|
|
Number of participants with Immune-related adverse events (irAEs) up to Week 170
Časové okno: Up to Week 170
|
Up to Week 170
|
|
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
Časové okno: Up to Week 49
|
Up to Week 49
|
|
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
Časové okno: Up to Week 170
|
Up to Week 170
|
|
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
Časové okno: Up to Week 49
|
Up to Week 49
|
|
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
Časové okno: Up to Week 170
|
Up to Week 170
|
|
Change from Baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 49
Časové okno: Baseline (Day 1) and up to 49
|
Baseline (Day 1) and up to 49
|
|
Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) to up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose, calcium, sodium, and potassium levels (Millimoles per Liter) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose, calcium, sodium, and potassium levels (Millimoles per Liter) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in clinical chemistry parameters: Total protein levels (Gram per liter) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in clinical chemistry parameters: Total protein levels (Gram per liter) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
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
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
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
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 49
Časové okno: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 170
Časové okno: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: GSK Clinical Trials, GlaxoSmithKline
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
17. srpna 2026
Primární dokončení (Odhadovaný)
30. srpna 2030
Dokončení studie (Odhadovaný)
30. srpna 2030
Termíny zápisu do studia
První předloženo
11. června 2026
První předloženo, které splnilo kritéria kontroly kvality
11. června 2026
První zveřejněno (Aktuální)
17. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Onemocnění dělohy
- Onemocnění pohlavních orgánů, ženy
- Genitální novotvary, ženy
- Novotvary dělohy
- Novotvary endometria
- Organické chemikálie
- Uhlovodíky
- Cykloparafiny
- Uhlovodíky, alicyklické
- Uhlovodíky, cyklické
- Terpeny
- Koordinační komplexy
- Taxoidy
- Cyclodecanes
- Diterpeny
- Karboplatina
- Paklitaxel
- Dostarlimab
Další identifikační čísla studie
- 309169
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
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
Časový rámec sdílení IPD
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.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ano
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Novotvary, endometrium
-
University of OklahomaDokončenoEndometriální rakovina | Papilární serózní | Clear Cell Endometrial CancerSpojené státy
-
University of OklahomaDokončenoEndometriální rakovina | Papilární serózní | Clear Cell Endometrial CancerSpojené státy
-
Instituto do Cancer do Estado de São PauloFinanciadora de Estudos e ProjetosNáborSarkom měkkých tkání | Adenoidní cystický karcinom | Novotvary vejcovodů | Rakovina epitelu vaječníků | Osteosarkom | Neuroendokrinní nádory | Karcinosarkom | Mezoteliom | Novotvary vulvy | Cholangiokarcinom | Leiomyosarkom | Novotvary štítné žlázy | Fibrosarkom | Neuroblastom | Kaposiho sarkom | Novotvary žlučových cest | Novotvary... a další podmínkyBrazílie
Klinické studie na Dostarlimab
-
University of Alabama at BirminghamNáborKarcinom | Gynekologická rakovina | Endometriální rakovina | Rakovina dělohySpojené státy
-
Chang Gung Memorial HospitalNábor
-
National Cancer Institute, NaplesNáborLokálně pokročilý karcinom rekta (LARC)Itálie
-
Diwakar DavarTesaro, Inc.Aktivní, ne náborMelanom stadium IV | Melanom stadium IIISpojené státy
-
University Health Network, TorontoGlaxoSmithKlineNáborRecidivující/metastatický spinocelulární karcinom hlavy a krkuKanada
-
GlaxoSmithKlineAktivní, ne náborNovotvary, rektálníSpojené státy, Španělsko, Německo, Itálie, Kanada, Holandsko, Japonsko, Francie, Spojené království, Jižní Korea
-
Queensland Centre for Gynaecological CancerGlaxoSmithKline Research & Development LimitedNáborPan Nedostatek | I. stadium rakoviny endometria | Nežádoucí příhoda související s imunitou | Endometrioidní endometriální adenokarcinomAustrálie
-
University of MiamiGlaxoSmithKlineStaženoGestační trofoblastická neoplazieSpojené státy
-
Tesaro, Inc.Aktivní, ne náborNovotvarySpojené státy, Španělsko, Polsko, Itálie, Spojené království, Dánsko, Kanada, Francie, Brazílie, Česko
-
University of OklahomaTesaro, Inc.Aktivní, ne náborRecidivující rakovina děložního čípku | Progresivní rakovina děložního čípkuSpojené státy