A Randomized Phase II, Double-blind, Multicenter Study Evaluating the Efficacy and Safety of Autogene Cevumeran Plus Nivolumab Versus Nivolumab as Adjuvant Therapy in Patients With High-risk Muscle-invasive Urothelial Carcinoma

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06534983Tipo: INTERVENTIONALInicio: 9 de dic de 2024Fin estimado: 6 de ene de 2034

Traducción no disponible, mostrando original

Resumen

The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the saline + nivolumab arm.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants who have not received any prior NAC are also eligible, provided they meet one of the following criteria, which would make them ineligible to receive adjuvant cisplatin-based therapy: participant refusal, cisplatin ineligibility or investigator decision
Tumor tissue must be provided for biomarker analysis
Participants must have the capacity to participate/enroll in the study and to provide informed consent
Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma \[TCC\]) of the bladder or upper urinary tract
Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control \[UICC\]/American Joint Committee on Cancer \[AJCC\] 7th edition) at pathological examination of surgical resection specimen of (y)pT3-4 or (y)pN+ and M0
Surgical resection of MIUC of the bladder or upper tract
Participants who have received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible
Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization
Full recovery from cystectomy or nephroureterectomy within 120 days following surgery
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Negative human immunodeficiency virus (HIV) test at screening
Negative hepatitis B surface antigen (HbsAg) test at screening
Positive hepatitis B surface antibody (HBsAb), or a negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< 500 international units/milliliter (IU/mL)
Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening

Criterios de exclusión

Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of renal pelvis primary tumor
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection
Prior active malignancies within 3 years prior to randomization
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment

Intervenciones

drug

Autogene Cevumeran

Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm.

drug

Nivolumab

Nivolumab will be administered as an IV infusion per the schedule specified in the arm.

drug

Saline

Saline solution for IV infusion.

Ubicaciones

Instituto Alexander Fleming

Buenos Aires, Argentina

RECRUITING

Hospital Britanico

Buenos Aires, Argentina

RECRUITING

Hospital Italiano

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

ColaboradorBioNTech SE

Contactos

Reference Study ID Number: BO45230 https://forpatients.roche.com/

CONTACT

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. Only)

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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