Estudio de fase II aleatorizado, doble ciego y multicéntr... | EligiMed

Estudio de fase II aleatorizado, doble ciego y multicéntrico para evaluar la eficacia y seguridad de autogene cevumeran más nivolumab versus nivolumab como terapia adyuvante en pacientes con carcinoma urotelial músculo-invasivo de alto riesgo

ReclutandoFase 2ClinicalTrials.gov

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

Resumen

El objetivo principal del estudio es evaluar la eficacia del tratamiento adyuvante con autogene cevumeran más nivolumab comparado con nivolumab en participantes con carcinoma urotelial músculo-invasivo (MIUC) de alto riesgo. En este estudio, los participantes serán incorporados en una fase de incorporación de seguridad para recibir autogene cevumeran + nivolumab. Esta fase se llevará a cabo para monitorear y garantizar la seguridad de los participantes del estudio. Una vez que todos los participantes de la fase de incorporación de seguridad hayan sido enrolados para recibir autogene cevumeran + nivolumab, los participantes adicionales serán aleatorizados al brazo de autogene cevumeran + nivolumab o al brazo de solución salina + nivolumab.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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
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
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)

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