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)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2024-12-09

Study Completion:2034-01-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06534983

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants must have the capacity to participate/enroll in the study and to provide informed consent * 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 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 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) 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 RNA test at screening	* 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 Criteria

Exclusion Criteria

* Participants must have the capacity to participate/enroll in the study and to provide informed consent
* 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 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 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) 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 RNA test at screening

* 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

Contacts and Locations

Study Contact

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

CONTACT

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

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Highlands Oncology Group.

Springdale, Arkansas, 72762

United States

City of Hope Cancer Center

Duarte, California, 91010

United States

Kaiser Permanente - Riverside

Riverside, California, 92505

United States

University of California San Francisco

San Francisco, California, 94158

United States

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, 20007

United States

Norton Cancer Institute

Louisville, Kentucky, 40207

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, 07920

United States

MSK Monmouth

Middletown, New Jersey, 07748

United States

MSK Bergen

Montvale, New Jersey, 07645

United States

MSK Commack

Commack, New York, 11725

United States

MSK Westchester

Harrison, New York, 10604

United States

Columbia University Irving Medical Center

New York, New York, 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

MSK Nassau

Uniondale, New York, 11553

United States

Providence Portland Medical Ctr

Portland, Oregon, 97225

United States

AHN Cancer Institute ? Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

United States

University of Washington Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-09

Study Completion Date2034-01-06

Study Record Updates

Study Start Date2024-12-09

Study Completion Date2034-01-06

Terms related to this study

Additional Relevant MeSH Terms

Muscle Invasive Urothelial Carcinoma