Donate
Back to Clinical Trials
Back to Clinical Trials

Brief Title: Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC)

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

INTRODUCTION

  • Org Study ID: BO45230
  • Secondary ID: N/A
  • NCT ID: NCT06534983
  • Sponsor: Hoffmann-La Roche

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 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 randomization in either autogene cevumeran + nivolumab or the saline + nivolumab arm.

  • Overall Status
    Recruiting
  • Start Date
    July 31, 2024
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Muscle Invasive Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
* 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 Criteria:
* 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Trials

Role: Study Director

Affiliation: Hoffmann-La Roche

Overall Contact

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

Phone: 888-662-6728 (U.S. Only)

Email: global-roche-genentech-trials@gene.com

LOCATION

Facility Status Contact
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States 		Status: Recruiting Contact: N/A

Read Our Stories