Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC)
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
BioNTech SE
Conditions:
Muscle-invasive Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 parti...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 6 2034
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT06534983
Start Date
December 9 2024
End Date
January 6 2034
Last Update
January 8 2026
Active Locations (100)
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1
Highlands Oncology Group.
Springdale, Arkansas, United States, 72762
2
City of Hope Cancer Center
Duarte, California, United States, 91010
3
Kaiser Permanente - Riverside
Riverside, California, United States, 92505
4
University of California San Francisco
San Francisco, California, United States, 94158