Un essai de phase III du BNT324 contre le docétaxel dans le cancer de la prostate métastatique résistant à la castration
Un essai de phase III, randomisé, ouvert de BNT324 versus Docétaxel avec Prednisone/Prednisolone dans le cancer de la prostate métastatique résistant à la castration
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.
The main goals of this study are:
- To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival [rPFS]).
- To find out if BNT324 helps participants live longer overall (overall survival [OS]).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study consists of a screening period (up to 28 days), a treatment period with 21-day cycles, and an after-treatment period that includes a 30-day safety follow-up period and a long-term survival follow-up period.
Treatment continues until the cancer clearly gets worse (in scans, based on blinded independent central review [BICR] assessment or investigator's decision), side effects become unacceptable, the participant chooses to stop, or the study ends.
Participants are put into one of two groups in a 1:1 ratio, which means they will have an equal chance to be in either treatment group, i.e., BNT324 group, or docetaxel plus prednisone/prednisolone group (current SoC). An independent committee will help ensure participant safety, by regularly reviewing safety and early results.
For each participant, the treatment and follow-up periods are projected to be up to ~58 months.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: BioNTech clinical trials patient information
- Numéro de téléphone: +49 6131 9084
- E-mail: patients@biontech.de
Lieux d'étude
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Dresden, Allemagne, 1307
- Recrutement
- Universitätsklinikum Carl Gustav Carus
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Hamburg, Allemagne, 22763
- Recrutement
- Asklepios Klinik Altona
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Southport, Australie, 4215
- Recrutement
- Tasman Onco Research Pty Ltd
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Brussels, Belgique, 1200
- Recrutement
- Cliniques Universitaires Saint-Luc
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Beijing, Chine, 100142
- Recrutement
- Beijing Cancer Hospital
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Beijing, Chine, 100034
- Recrutement
- Peking University First Hospital
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Changsha, Chine, 410005
- Recrutement
- The First Affiliated Hospital of Hunan Normal University
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Chengdu, Chine, 610041
- Recrutement
- West China Hospital, Sichuan University
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Chongqing, Chine, 400072
- Recrutement
- The Second Affiliated Hospital of Chongqing Medical University
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Fuzhou, Chine, 350001
- Recrutement
- Fujian Medical University Union Hospital
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Hangzhou, Chine, 310022
- Recrutement
- Zhejiang Cancer Hospital
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Hangzhou, Chine, 310016
- Recrutement
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hefei, Chine, 230601
- Recrutement
- Second Hospital of Anhui Medical University
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Nanchang, Chine, 330006
- Recrutement
- The First Affiliated Hospital of Nanchang University
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Nanjing, Chine, 210008
- Recrutement
- Nanjing Drum Tower Hospital
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Shanghai, Chine, 200032
- Recrutement
- Shanghai Cancer Center
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Shanghai, Chine, 200072
- Recrutement
- No. 10 People's Hospital of Shanghai
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Wenzhou, Chine, 325000
- Recrutement
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Chine, 430079
- Recrutement
- Hubei Cancer Hospital
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Wuhan, Chine, 420104
- Recrutement
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhu, Chine, 241001
- Recrutement
- Yijishan Hospital of Wannan Medical College
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Yantai, Chine, 264000
- Recrutement
- Yantai Yuhuangding Hospital
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Krakow, Pologne, 30-727
- Recrutement
- Pratia MCM Krakow
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Warsaw, Pologne, 02-781
- Recrutement
- National Research Institute of Oncology - National Research Institute (NIO-PIB)
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Cambridge, Royaume-Uni, CB2 0QQ
- Recrutement
- Addenbrooke's Hospital
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Cardiff, Royaume-Uni, CF14 2TL
- Recrutement
- Velindre Cancer Centre
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Leeds, Royaume-Uni, LS9 7TF
- Recrutement
- St James's University Hospital
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London, Royaume-Uni, SW3 6JJ
- Recrutement
- Royal Marsden Hospital
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Newcastle upon Tyne, Royaume-Uni, NE7 7DN
- Recrutement
- Freeman Hospital
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Southampton, Royaume-Uni, SO16 6YD
- Recrutement
- Southampton General Hospital
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Sutton, Royaume-Uni, SM2 5PT
- Recrutement
- Royal Marsden Hospital
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California
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Santa Barbara, California, États-Unis, 93105
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- Sansum Clinic
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Colorado
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Aurora, Colorado, États-Unis, 80012
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- Rocky Mountain Cancer Centers
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Florida
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Fort Myers, Florida, États-Unis, 33901
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- Florida Cancer Specialists- Fort Myers
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St. Petersburg, Florida, États-Unis, 33701
- Recrutement
- Florida Cancer Specialists- St. Petersburg
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West Palm Beach, Florida, États-Unis, 33401
- Recrutement
- Florida Cancer Specialists- West Palm Beach
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Georgia
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Atlanta, Georgia, États-Unis, 30318
- Recrutement
- Piedmont Cancer Institute
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Illinois
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Niles, Illinois, États-Unis, 60714
- Recrutement
- Illinois Cancer Specialists
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Peoria, Illinois, États-Unis, 61615
- Recrutement
- Illinois CancerCare PC
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Maryland
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Rockville, Maryland, États-Unis, 20850
- Recrutement
- Maryland Oncology Hematology
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New York
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Albany, New York, États-Unis, 12206
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- NYOH Albany Cancer Center
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White Plains, New York, États-Unis, 10601
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- White Plains Hospital
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Ohio
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Cincinnati, Ohio, États-Unis, 45242
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- Oncology/Hematology Care, Inc.
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South Carolina
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Myrtle Beach, South Carolina, États-Unis, 29572
- Recrutement
- START Carolinas
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Tennessee
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Tennessee Oncology
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Nashville, Tennessee, États-Unis, 37203
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- SCRI Oncology Partners
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Texas
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Austin, Texas, États-Unis, 78731
- Recrutement
- Texas Oncology South Austin
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Houston, Texas, États-Unis, 77024
- Recrutement
- Texas Oncology Gulf Coast
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Tyler, Texas, États-Unis, 75702
- Recrutement
- Texas Oncology, P.A. - Tyler
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Wichita Falls, Texas, États-Unis, 76310
- Recrutement
- Texas Oncology - West Texas
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Virginia
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Fairfax, Virginia, États-Unis, 22031
- Recrutement
- Virginia Cancer Specialists PC
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Norfolk, Virginia, États-Unis, 23502
- Recrutement
- Virginia Oncology Associates
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Key Inclusion Criteria:
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Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
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Must have documented progressive prostate cancer based on at least one of the following criteria:
- Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL.
- Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.
- Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.
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Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.
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Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.
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Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.
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Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.
Key Exclusion Criteria:
- Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.
- Have uncontrolled or significant cardiovascular disease, as defined in the protocol.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis.
NOTE: Other protocol defined Inclusion/Exclusion criteria 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 |
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Expérimental: BNT324
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Intravenous infusion
Autres noms:
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Comparateur actif: Docétaxel plus prednisone/prednisolone
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Intravenous infusion Oral |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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rPFS assessed by BICR
Délai: From randomization to end of study, i.e., up to 58 months
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By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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OS
Délai: From randomization to end of study, i.e., up to 58 months
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By arm. OS is defined as time from randomization to death from any cause. |
From randomization to end of study, i.e., up to 58 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Time to first subsequent therapy (TFTS)
Délai: From randomization to end of study, i.e., up to 58 months
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By arm. TFST is defined as time from randomization to initiation of the first subsequent systemic anticancer therapy or death, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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Objective response rate (ORR)
Délai: From randomization to end of study, i.e., up to 58 months
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By arm. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per PCWG3-modifed RECIST v1.1 as assessed by BICR) is observed as best overall response. |
From randomization to end of study, i.e., up to 58 months
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Duration of response (DOR)
Délai: From randomization to end of study, i.e., up to 58 months
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By arm. DOR is defined as time from first objective response (confirmed CR or PR per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) to first occurrence of objective tumor progression (progressive disease per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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Time to pain progression (TTPP)
Délai: From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
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By arm. TTPP is defined as time from randomization to pain progression as determined by Brief Pain Inventory-Short Form Item 3 "worst pain in 24 hours" and opiate analgesic use (Analgesic Quantification Algorithm score). |
From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
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rPFS as assessed by investigator
Délai: From randomization to end of study, i.e., up to 58 months
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By arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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Time to first symptomatic skeletal-related event (SSRE)
Délai: From randomization to end of study, i.e., up to 58 months
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By arm. Time to first SSRE is defined as time from randomization to first occurrence of any of the following SSREs:
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From randomization to end of study, i.e., up to 58 months
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Time to prostate-specific antigen (PSA) progression (by central lab testing results)
Délai: From baseline to end of treatment visit, i.e., up to 58 months
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By arm. Time to PSA progression is defined as time from randomization to PSA progression per PCWG3 criteria. |
From baseline to end of treatment visit, i.e., up to 58 months
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PSA response (by central lab testing results)
Délai: From baseline to end of treatment visit, i.e., up to 58 months
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By arm. PSA response is defined as having a post-baseline PSA reduction ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG3 criteria. |
From baseline to end of treatment visit, i.e., up to 58 months
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Number and percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs
Délai: From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
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TEAEs by relationship and by arm. |
From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
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Number and percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs
Délai: From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
By arm. |
From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: BioNTech Responsible Person, BioNTech SE
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BNT324-03
- 2025-524445-27-00 (Ctis)
- 2025 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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