Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1 (MAESTRA 3)
4 de setembro de 2026 atualizado por: Incyte Corporation
A Phase 3, Double-Blind, Randomized, Controlled Study of INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1 (MAESTRA 3)
The purpose of this study is to evaluate INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
590
Estágio
- Fase 3
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: Incyte Corporation Call Center (US)
- Número de telefone: 1.855.463.3463
- E-mail: medinfo@incyte.com
Estude backup de contato
- Nome: Incyte Corporation Call Center (ex-US)
- Número de telefone: +800 00027423
- E-mail: eumedinfo@incyte.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:
- Newly diagnosed, histologically confirmed, FIGO Stage III or IV, high-grade serous, high-grade endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer.
- Underwent debulking surgery prior to randomization (either PDS or IDS).
Completed first-line platinum-based chemotherapy in combination with bevacizumab prior to randomization.
- Received a minimum of 6 cycles (and no more than 8 cycles) of platinum-taxane chemotherapy.
- Received at least 2 infusions of bevacizumab concurrently with the last 2 to 3 cycles of chemotherapy.
- No clinical evidence of disease recurrence (ie, NED following surgery) or progression (ie, CR/PR/SD per RECIST v1.1) on completion of platinum-based chemotherapy.
- Tumor overexpresses cyclin E1.
- Has a local HRD (positive or negative) or BRCA test result available. Participants with BRCA wild-type must have a local HRD result based on a validated test.
- ECOG performance status of 0 or 1.
Exclusion Criteria:
- Ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin or low-grade ovarian cancer.
- Deleterious tumor BRCA mutation per local test.
- Eligible for treatment with a PARPi as maintenance therapy.
- Known additional malignancy that progressed or requires active treatment, or history of other malignancy within 3 years prior to randomization.
- History of any clinically significant or uncontrolled cardiovascular disease within 6 months prior to randomization.
- Clinically significant gastrointestinal abnormality.
- History of thromboembolism and having been on therapeutic anticoagulation for less than 2 weeks prior to randomization.
- Current treatment with any strong CYP3A4/CYP3A5 inhibitor or inducer or treatment with a strong CYP3A4/CYP3A5 inhibitor or inducer within 5 half-lives or 28 days (whichever is shorter) prior to randomization.
Exclusionary Laboratory Values:
- Platelets: < 100 × 109/L
- Hemoglobin: < 9 g/dL or < 5.6 mmol/L
- ANC: < 1.5 × 109/L
- ALT: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
- AST: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
- Total bilirubin: ≥ 1.5 × ULN
- Albumin: < 2.5 g/dL
- Calculated CrCl: < 45 mL/min
- Protein in urine: Urine dipstick for proteinuria ≥ 2+
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Treatment Group A (TGA)
Bevacizumab plus INCB123667 at the protocol defined dose.
|
INCB123667 will be administered at the protocol defined dose.
Bevacizumab will be administered at the protocol defined dose.
|
|
Experimental: Treatment Group B (TGB)
Bevacizumab plus matching placebo at the protocol defined dose.
|
Bevacizumab will be administered at the protocol defined dose.
Placebo will be administered at the protocol defined dose.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS) by BICR
Prazo: Up to approximately 5 years
|
Defined as the time from randomization until the first documented disease progression or disease recurrence as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
|
Up to approximately 5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: Up to approximately 7 years
|
Defined as the time from randomization until death due to any cause.
|
Up to approximately 7 years
|
|
Progression-Free Survival (PFS) by investigator
Prazo: Up to approximately 5 years
|
Defined as the time from randomization until the first documented disease progression or disease recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
|
Up to approximately 5 years
|
|
Progression-Free Survival on the First Subsequent Therapy (PFS2)
Prazo: Up to approximately 7 years
|
Defined as the time from randomization until radiologic or clinical disease progression on the first subsequent therapy as assessed by the investigator, or death due to any cause, whichever occurs first.
|
Up to approximately 7 years
|
|
Second Progression-Free Survival (PFS)
Prazo: Up to approximately 7 years
|
Defined as the time from the start of the first subsequent therapy until radiologic or clinical disease progression as assessed by the investigator.
|
Up to approximately 7 years
|
|
Time to First Subsequent Therapy (TFST)
Prazo: Up to approximately 7 years
|
Defined as the time from randomization until the start of the first subsequent therapy, or death due to any cause, whichever occurs first.
|
Up to approximately 7 years
|
|
Time to Second Subsequent Therapy (TSST)
Prazo: Up to approximately 7 years
|
Defined as the time from randomization until the start of the second subsequent therapy, or death due to any cause, whichever occurs first.
|
Up to approximately 7 years
|
|
Treatment Emergent Adverse Events (TEAEs)
Prazo: Up to approximately 13 months
|
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.
|
Up to approximately 13 months
|
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Prazo: Up to approximately 13 months
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
|
Up to approximately 13 months
|
|
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit
Prazo: Up to approximately 5 years
|
The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in patients with cancer.
It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.
|
Up to approximately 5 years
|
|
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) -Ovarian Cancer 28 (OV28) score at each postbaseline visit
Prazo: Up to approximately 5 years
|
The EORTC QLQ-OV28 is a validated, self-administered questionnaire developed as a supplementary module to the core QLQ-C30, specifically designed to assess HRQoL in participants with ovarian cancer.
It contains 28 questions across several subscales, including 5 symptom scales (abdominal/gastrointestinal, peripheral neuropathy, hormonal/menopausal, chemotherapy side effects, and attitudes towards disease/treatment), 2 functional scales (body image and sexual functioning), and a number of single-item measures addressing issues such as other abdominal symptoms and hair loss.
|
Up to approximately 5 years
|
|
Change from baseline in EQ-5D-5L score at each postbaseline visit
Prazo: Up to approximately 5 years
|
The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 response levels of severity, ranging from no problems to extreme problems.
The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
|
Up to approximately 5 years
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Incyte Medical Monitor, Incyte Corporation
Publicações e links úteis
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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)
1 de dezembro de 2026
Conclusão Primária (Estimado)
1 de maio de 2032
Conclusão do estudo (Estimado)
1 de maio de 2034
Datas de inscrição no estudo
Enviado pela primeira vez
26 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de agosto de 2026
Primeira postagem (Real)
1 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças do Sistema Endócrino
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Genitais Femininas
- Neoplasias das Glândulas Endócrinas
- Doenças ovarianas
- Doenças anexiais
- Neoplasias Genitais Femininas
- Distúrbios Gonadais
- Neoplasias ovarianas
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Anticorpos, monoclonais, humanizados
- Anticorpos, monoclonais
- Anticorpos
- Imunoglobulinas
- Imunoproteínas
- Proteínas sanguíneas
- Globulinas de soro
- Globulins
- Bevacizumabe
Outros números de identificação do estudo
- INCB123667-302
- 2026-526071-30-00 (Identificador de registro: EU CT Number)
- ENGOT-OV106 (Outro identificador: ENGOT Study Number)
- GOG-3146 (Outro identificador: GOG Foundation)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Incyte shares data with qualified external researchers after a research proposal is submitted.
These requests are reviewed and approved by a review panel on the basis of scientific merit.
All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Prazo de Compartilhamento de IPD
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Critérios de acesso de compartilhamento IPD
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com
website.
For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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
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 .