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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

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

Studijní záloha kontaktů

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

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 .

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