Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

A Phase III Study of Atezolizumab Treatment Versus Observation as Adjuvant Therapy in Patients With PD-L1 Positive, High Risk Muscle Invasive Bladder Cancer After Cystectomy [IMvigor010]

Protocol: OSU-16078

Full Title

A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti−Pd-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients with Pd-L1−Selected, High-Risk Muscle-Invasive Bladder Cancer after Cystectomy

Purpose

This study is to evaluate the efficacy and safety of adjuvant treatment with Atezolizumab

compared with observation in participants with PD-L1-selected muscle-invasive bladder cancer

(MIBC) who are at high risk for recurrence following cystectomy.

Are you eligible?

Inclusion Criteria:

Age >/= 18 years

Histologically or cytologically confirmed muscle-invasive TCC of the bladder

(excluding TCC of renal pelvis, ureters, or urethra) which is PD-L1 positive

For patients who have not received prior neoadjuvant chemotherapy, refusal of or

ineligibility for cisplatin-based adjuvant chemotherapy

Representative tumor specimens as specified by the protocol

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 6 weeks prior to randomization

Full recovery from cystectomy and randomization within 12 weeks following surgery

Eastern Cooperative Oncology Group (ECOG) performance status of </= 2

Life expectancy >/= 12 weeks

Adequate hematologic and end-organ function

For women who are not postmenopausal or surgically sterile: agreement to remain

abstinent or use single or combined contraceptive methods that result in a failure

rate of <1% per year during the treatment period and for at least 90 days after the

last dose of study drug

Exclusion Criteria:

Any approved anti-cancer therapy within 3 weeks prior to initiation of study

treatment

Adjuvant chemotherapy or radiation therapy for urothelial carcinoma (UC) following

cystectomy

Treatment with any other investigational agent or participation in another clinical

trial with therapeutic intent within 28 days prior to enrollment

Malignancies other than UC within 5 years prior to Cycle 1, Day 1

Pregnancy or breastfeeding

Significant cardiovascular disease

Severe infections within 4 weeks prior to randomization

Major surgical procedure other than for diagnosis within 4 weeks prior to

randomization

History of severe allergic, anaphylactic, or other hypersensitivity reactions to

chimeric or humanized antibodies or fusion proteins; known hypersensitivity or

allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any

component of the MPDL3280A formulation

History of autoimmune disease

Prior allogeneic stem cell or solid organ transplant

History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced

pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening

chest CT scan

Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis

Administration of a live, attenuated vaccine within 4 weeks prior to randomization

Prior treatment with CD137 agonists or immune checkpoint blockade therapies,

including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

Bladder Cancer Genitourinary Cancers