Efficacy and Safety of BG-C9074 With Bevacizumab Compared With Bevacizumab in Adults With Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
A Phase 3, Open-label, Multicenter, Randomized Study of BG-C9074 With Bevacizumab Versus Bevacizumab as First-line Maintenance Therapy for Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After First-line Platinum-based Chemotherapy Plus Bevacizumab (Starstone-Ovarian 301/GOG-3144/ENGOT-ov108/APGOT-OV29)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Ovarian cancer is a disease where abnormal cells in the ovaries or fallopian tubes grow out of control and form tumors. Common early signs include belly bloating, pelvic or back pain, feeling full quickly when eating, and frequent urination.
BG-C9074 is a targeted cancer medicine called an antibody-drug conjugate (ADC). ADC consists of an antibody linked to a drug that can kill cancer cells. The antibody part of BG-C9074 specifically attaches to a protein called B7-H4 that is found on the surface of cancer cells. After it attaches to B7-H4, BG-C9074 enters the cancer cell where the drug causes DNA damage and cell death. Bevacizumab is an approved medicine used to treat these cancers along with chemotherapy. It works by cutting off the blood supply that helps the tumor grow, which may help keep the cancer under better control.
The purpose of this study is to test if BG-C9074 is safe and effective in women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer when it is given in combination with bevacizumab as a first-line maintenance treatment.
This study has 2 treatment groups. Participants will be randomly assigned (by chance, like flipping a coin) to receive one of the treatments listed below:
- Arm A: BG-C9074 + Bevacizumab
- Arm B: Bevacizumab
This study will enroll approximately 600 participants. The overall time to participate in this study may be up to 5 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and for tumor and imaging tests.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: BeOne Medicines
- Numéro de téléphone: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Participants must have a histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (serous, endometrioid, or clear cell).
- Participants are newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III or IV and have received primary debulking surgery or interval debulking surgery.
- Participants must have adequate organ function.
- Women of childbearing potential must be willing to use a highly effective method of birth control and agree not to donate eggs (ova, oocytes) or freeze/store eggs for the duration of the study and for ≥ 7 months after the last dose of study treatment.
Exclusion Criteria:
- Participants have ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin.
- Participants have either a germline or somatic BReast CAncer gene (BRCA) mutation as per local test.
- Participants who will receive poly-adenosine diphosphate ribose polymerase (PARP) inhibitor as maintenance therapy per standard of care and investigator discretion.
- Participants have a history of allergic reactions or hypersensitivity to the active ingredients and excipients of the drug products and other monoclonal antibodies.
- Participants had previous transient ischemic attack, cerebrovascular accident, or subarachnoid hemorrhage within 6 months prior to randomization
- Participants have evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm A: BG-C9074 + Bevacizumab
BG-C9074 will be administered first, followed by bevacizumab.
|
Administered by Intravenous infusion
Administered by Intravenous infusion
|
|
Comparateur actif: Arm B: Bevacizumab
Bevacizumab will be administered alone.
|
Administered by Intravenous infusion
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Délai: Up to 5 years
|
PFS is defined as the time from randomization to the date of disease progression by BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever occurs first.
|
Up to 5 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: Up to 5 years
|
OS is defined as the time from randomization to death due to any reason.
|
Up to 5 years
|
|
PFS, as Assessed by Investigator
Délai: Up to 5 years
|
PFS is defined as time from randomization to the date of disease progression by Investigator based on RECIST v1.1 or death, whichever occurs first.
|
Up to 5 years
|
|
PFS2, as Assessed by Investigator
Délai: Up to 5 years
|
PFS2, as assessed by investigator, is defined as time from randomization to the documented disease progression on first subsequent systemic therapy by Investigator or death due to any cause, whichever occurs first.
|
Up to 5 years
|
|
Time to Next Treatment
Délai: Up to 5 years
|
Time to next treatment is defined as the time from randomization to the start of the first subsequent anticancer therapy after discontinuation of randomized treatment, or death due to any cause.
|
Up to 5 years
|
|
Number of Participants with Treatment-Emergent Adverse Events, Treatment-Related Adverse Events, and Serious Adverse Events
Délai: From first dose of study drug up to 30 days after last dose, up to 24 months
|
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment, whether considered related to study treatment or not. A serious adverse event is any untoward medical occurrence that, at any dose, meets one or more of the criteria listed in the view of either the investigator or the Sponsor:
|
From first dose of study drug up to 30 days after last dose, up to 24 months
|
|
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) - F17 Global Health Status/Quality of Life (GHS/QoL), Role Functioning, and Physical Functioning Domain Scores
Délai: Baseline and up to approximately 2 years
|
The EORTC QLQ-F17 is a 17-item questionnaire that covers GHS/QoL and five functional scales (Physical, Role, Emotional, Cognitive, and Social).
All items are scored on a 4-point - Likert scale (1 = "Not at all"; 4 = "Very much"), except the two items of the GHS/QoL-scale that are scored on a 7-point scale (1 = "Very poor"; 7 = "Excellent").
Scores are averaged and transformed to a 0 to 100 scale.
Higher scores in GHS/QoL and functional scales indicate better health-related quality of life (HRQoL).
|
Baseline and up to approximately 2 years
|
|
Change from Baseline in EORTC QLQ -Ovarian Cancer Module (OV28) Abdominal/GI Symptoms Domain Score
Délai: Baseline and up to approximately 2 years
|
The EORTC QLQ-OV28 includes a 28-item questionnaire for evaluating ovarian cancer-specific symptoms and concerns in participants of cancer clinical studies.
These include items that assess symptoms in the abdominal/gastrointestinal domain.
Scores are averaged and transformed to a 0 to 100 scale; higher scores indicate a greater symptom burden, while lower scores reflect fewer symptoms.
|
Baseline and up to approximately 2 years
|
|
Time to Deterioration (TTD) of GHS/QoL, Role Functioning, and Physical Functioning Domain Scores as Measured via EORTC QLQ - F17
Délai: Up to 5 years
|
TTD of GHS/QoL is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal/gastrointestinal symptom domain of the EORTC QLQ-F17.
|
Up to 5 years
|
|
Time to deterioration (TTD) of Abdominal/GI Symptoms as Measured via EORTC QLQ - OV28
Délai: Up to 5 years
|
TTD of Abdominal/GI Symptoms is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal/gastrointestinal symptom domain of the EORTC QLQ-OV28.
|
Up to 5 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Study Director, BeOne Medicines
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
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
- Tumeurs par type histologique
- Maladies génitales, femme
- Tumeurs des glandes endocrines
- Tumeurs, glandulaires et épithéliales
- Maladies ovariennes
- Maladies annexielles
- Tumeurs génitales, femme
- Troubles gonadiques
- Carcinome
- Maladies des trompes de Fallope
- Tumeurs ovariennes
- Carcinome épithélial ovarien
- Tumeurs des trompes de Fallope
- 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
- BG-C9074-301
- 2026-527172-84-00 (Ctis)
- GOG-3144 (Autre identifiant: Gynecologic Oncology Group (GOG))
- ENGOT-ov108 (Autre identifiant: European Network of Gynaecological Oncological Trial Groups (ENGOT))
- APGOT-OV29 (Autre identifiant: Asia-Pacific Gynecologic Oncology Trials Group (APGOT))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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