Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1 (MAESTRA 3)
4 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
590
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Incyte Corporation Call Center (US)
- Numéro de téléphone: 1.855.463.3463
- E-mail: medinfo@incyte.com
Sauvegarde des contacts de l'étude
- Nom: Incyte Corporation Call Center (ex-US)
- Numéro de téléphone: +800 00027423
- E-mail: eumedinfo@incyte.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS) by BICR
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Incyte Medical Monitor, Incyte Corporation
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 décembre 2026
Achèvement primaire (Estimé)
1 mai 2032
Achèvement de l'étude (Estimé)
1 mai 2034
Dates d'inscription aux études
Première soumission
26 août 2026
Première soumission répondant aux critères de contrôle qualité
26 août 2026
Première publication (Réel)
1 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Maladies du système endocrinien
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies génitales, femme
- Tumeurs des glandes endocrines
- Maladies ovariennes
- Maladies annexielles
- Tumeurs génitales, femme
- Troubles gonadiques
- Tumeurs ovariennes
- Acides aminés, peptides et protéines
- Protéines
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Bévacizumab
Autres numéros d'identification d'étude
- INCB123667-302
- 2026-526071-30-00 (Identificateur de registre: EU CT Number)
- ENGOT-OV106 (Autre identifiant: ENGOT Study Number)
- GOG-3146 (Autre identifiant: GOG Foundation)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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
Délai de partage IPD
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .