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)

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.

Conditions

Muscle Invasive Urothelial Carcinoma
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Related Conditions:

Muscle Invasive Urothelial Carcinoma

Study Overview

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Study Details

Study overview

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.

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

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)

Condition
Muscle Invasive Urothelial Carcinoma
Intervention / Treatment

-

Contacts and Locations

Springdale

Highlands Oncology Group., Springdale, Arkansas, United States, 72762

Duarte

City of Hope Cancer Center, Duarte, California, United States, 91010

Riverside

Kaiser Permanente - Riverside, Riverside, California, United States, 92505

San Francisco

University of California San Francisco, San Francisco, California, United States, 94158

Washington D.C.

Georgetown University Medical Center Lombardi Cancer Center, Washington D.C., District of Columbia, United States, 20007

Louisville

Norton Cancer Institute, Louisville, Kentucky, United States, 40207

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Basking Ridge

Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey, United States, 07920

Middletown

MSK Monmouth, Middletown, New Jersey, United States, 07748

Montvale

MSK Bergen, Montvale, New Jersey, United States, 07645

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2034-01-06