Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer

2018-05-23 19:36:12 | BioPortfolio


This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer.


Patients will be randomized in a 1:1:1 ratio to receive treatment with Durvalumab + BCG combination therapies, or Standard of Care (SoC) therapy.

Study Design


Non-muscle-invasive Bladder Cancer


Durvalumab (MEDI4736), Bacillus Calmette-Guerin (BCG)


Research Site
Box Hill


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2018-05-23T19:36:12-0400

Clinical Trials [2429 Associated Clinical Trials listed on BioPortfolio]

Adding Mitomycin C to Bacillus of Calmette-Guerin (BCG) as Adjuvant Intravesical Therapy for High-risk, Non-Muscle-invasive Bladder Cancer

Open label, randomised phase 3 trial of the addition of Mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to compare d...

Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients

The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will ge...

Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ...

Bacillus Calmette-Guerin Followed by Sunitinib for the Treatment of High Risk Non-muscle Invasive Lower Urinary Tract Urothelial Carcinoma

A majority of patients with bladder cancer have disease confined to the inner lining of the bladder. Patients with high risk features (high grade tumors, tumors invading into a deeper sup...

Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer

The purpose of this study is to test the safety of avelumab and Bacille Calmette-Guerin (BCG) and see what effects (good and bad) that this combination treatment has on subjects with recur...

PubMed Articles [7394 Associated PubMed Articles listed on BioPortfolio]

A Rare Case of Granulomatous Pneumonitis Due to Intravesical BCG for Bladder Cancer.

Granulomatous pneumonitis is a rare complication of bacillus Calmette-Guerin immunotherapy following intravesical administration of bacillus Calmette-Guerin. The authors present an unusual case of a 6...

A rare case of multi-focal human TB after BCG instillation for non-muscle-invasive bladder cancer.

To describe a left epididymitis and para-aortical involvement caused by reactivation after bacillus Calmette-Guérin instillation for non-muscle-invasive bladder cancer.

Emerging Immunotherapy Options for BCG-unresponsive Non-muscle-invasive Bladder Cancer.

Due to the high rate of recurrence and progression in patients with high-risk non-muscle-invasive bladder cancer (NMIBC), there exists an important unmet need to identify new therapies. This is especi...

Bacillus Calmette-Guérin in Immunosuppressed Patient with High-Grade Nonmuscle Invasive Bladder Carcinoma.

Due to their immunosuppressed status, solid organ transplant recipients are a special group of patients with an incidence of bladder cancer greater than the rest of the population, especially in the f...

Evolution of the Bacillus Calmette-Guerin Scar and Its Association with Birth and Pregnancy Characteristics in a Prospective Cohort of Infants in Iquitos, Peru.

 Bacillus Calmette-Guerin (BCG) scar formation is considered a visual marker of vaccination and cell-mediated immune response. This study characterized the association between pregnancy and birth ch...

Medical and Biotech [MESH] Definitions

Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.

Viruses whose host is Bacillus. Frequently encountered Bacillus phages include bacteriophage phi 29 and bacteriophage phi 105.

A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.

Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.

An alkalophilic species of Bacillus that occurs in soil. It produces ANTI-BACTERIAL AGENTS and is used as a PROBIOTIC.

More From BioPortfolio on "Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Bladder Cancer
Non-invasive bladder cancer is a cancer that is only in the inner lining of the bladder. Invasive bladder cancer is cancer that has spread into the deeper walls of the bladder. When the cancer has spread outside the bladder to other parts of the body, th...

Searches Linking to this Trial