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- Ensaio Clínico NCT07652515
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer
11 de junho de 2026 atualizado por: 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).
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: US GSK Clinical Trials Call Center
- Número de telefone: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
Estude backup de contato
- Nome: EU GSK Clinical Trials Call Center
- Número de telefone: +44 (0) 20 89904466
- E-mail: GSKClinicalSupportHD@gsk.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
Dostarlimabe será administrado.
Carboplatina será administrada.
Paclitaxel será administrado.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49
Prazo: Up to Week 49
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Up to Week 49
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Number of participants with Grade 3 or greater TEAEs up to Week 170
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to Week 170
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: GSK Clinical Trials, GlaxoSmithKline
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
17 de agosto de 2026
Conclusão Primária (Estimado)
30 de agosto de 2030
Conclusão do estudo (Estimado)
30 de agosto de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
11 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de junho de 2026
Primeira postagem (Real)
17 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças uterinas
- Doenças Genitais Femininas
- Neoplasias Genitais Femininas
- Neoplasias uterinas
- Neoplasias endometriais
- Produtos químicos orgânicos
- Hidrocarbonetos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Terpenos
- Complexos de coordenação
- Taxóides
- Ciclodecanos
- Diterpenos
- Carboplatina
- Paclitaxel
- Dostarlimab
Outros números de identificação do estudo
- 309169
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .