Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
In this study participants will be enrolled in a safety run-in phase to receive a mRNA cancer vaccine (called autogene cevumeran) + nivolumab immunotherapy. 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 randomly allocated into one of two treatment groups: to receive autogene cevumeran + nivolumab, or to receive nivolumab + saline.
Conditions
This trial is treating people with muscle-invasive urothelial carcinoma of the bladder or upper urinary tract who have had surgery to remove their cancer
Eligibility
Inclusion
- Histologically confirmed muscle-invasive UC (also termed TCC) of the bladder or upper urinary tract
- TNM classification (UICC/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 not received prior neoadjuvant cisplatin chemotherapy (NAC) must be ineligible to receive adjuvant cisplatin therapy due to patient 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 HIV test at screening
- No evidence of active hepatitis B, defined as having a negative hepatitis B surface antigen (HbsAg) test at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV 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
- Any prior neoadjuvant immunotherapy
- Adjuvant chemotherapy or radiation therapy for UC following surgical resection
- Malignancies other than UC within 5 years prior to randomization
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hoffmann-La Roche
Scientific Title
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
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