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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 giugno 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Verrà somministrato Dostarlimab.
Verrà somministrato carboplatino.
Verrà somministrato paclitaxel.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49
Lasso di tempo: Up to Week 49
Up to Week 49

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Number of participants with Grade 3 or greater TEAEs up to Week 170
Lasso di tempo: Up to Week 170
Up to Week 170
Number of participants with TEAEs up to Week 49
Lasso di tempo: Up to Week 49
Up to Week 49
Number of participants with TEAEs up to Week 170
Lasso di tempo: Up to Week 170
Up to Week 170
Number of participants with Immune-related adverse events (irAEs) up to Week 49
Lasso di tempo: Up to Week 49
Up to Week 49
Number of participants with Immune-related adverse events (irAEs) up to Week 170
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline (Day 1) and up to Week 170
Baseline (Day 1) and up to Week 170

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Direttore dello studio: GSK Clinical Trials, GlaxoSmithKline

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

17 agosto 2026

Completamento primario (Stimato)

30 agosto 2030

Completamento dello studio (Stimato)

30 agosto 2030

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano 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

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dostarlimab

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