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Durvalumab + Chemotherapy for Bladder Cancer (NIAGARA Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 or 1

Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 84 months

Awards & highlights

NIAGARA Trial Summary

This trial is testing a new cancer treatment for patients with muscle-invasive bladder cancer. The treatment is a combination of durvalumab (a drug that boosts the immune system) and gemcitabine+cisplatin (a chemotherapy drug). The trial will test the efficacy and safety of this new treatment.

Who is the study for?

This trial is for adults with muscle-invasive bladder cancer (MIBC) who haven't had chemo or immunotherapy for it, are expected to live at least 12 weeks, and plan to have their bladder removed. They should be fairly active (ECOG 0-1), not have advanced cancer spread, no recent vaccines or immune therapies, and can't be on strong immune-suppressing drugs.Check my eligibility

What is being tested?

The study tests Durvalumab combined with Gemcitabine+Cisplatin before bladder removal surgery and then Durvalumab alone after surgery. It aims to see if this combo is effective and safe in treating MIBC compared to current treatments.See study design

What are the potential side effects?

Durvalumab may cause immune-related side effects like inflammation of organs, skin reactions, hormone gland problems; Cisplatin/Gemcitabine can cause nausea, kidney damage, hearing loss. Side effects vary from person to person.

NIAGARA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My bladder cancer is operable and has not spread beyond nearby tissues or lymph nodes.

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I am scheduled for a surgery to remove my bladder.

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I have not had chemotherapy or immunotherapy for my bladder cancer.

NIAGARA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 84 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 84 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 84 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free survival (EFS) per central review defined as time from randomization to event

Pathologic complete response (pCR) rates at time of cystectomy

Secondary outcome measures

Disease-free survival

Disease-specific survival per investigator assessment or local biopsy review.

EFS at 24 months (EFS24) defined as time from randomization to event

+8 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Constipation

30%

Anorexia

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Back pain

15%

Cough

15%

Abdominal Pain

15%

Weight gain

15%

Increased Urinary Frequency

13%

Arthralgia

10%

Anxiety

10%

Bladder infection

10%

Dizziness

10%

Nasal congestion

10%

Vaginal discharge

Edema limbs

Fever

Anal pain

Dry skin

Colitis

Thromboembolic event

Dry mouth

Flatulence

Headache

Hot flashes

Myalgia

Urinary tract pain

Urinary frequency

Small intestinal obstruction

Anemia

Ascites

Confusion

Pneumonitis

Sinus bradycardia

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Memory impairment

Vaginal hemorrhage

Hypomagnesemia

Upper respiratory infection

Mucositis oral

Rash acneiform

Urinary urgency

Gastroesophageal reflux disease

Lymphedema

Rectal hemorrhage

Colonic perforation

Generalized muscle weakness

Hyperkalemia

Lethargy

Myocarditis

Fall

Skin infection

Hypothyroidism

Muscle weakness left-sided

Alanine aminotransferase increased

Hyperglycemia

Pleural effusion

Creatinine increased

Rectal pain

Aspartate aminotransferase increased

Dysarthria

Myositis

CPK increased

Pain in extremity

Peripheral sensory neuropathy

Alkaline phosphatase increased

Blood bilirubin increased

Left ventricular systolic dysfunction

Weight Loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

NIAGARA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1Experimental Treatment3 Interventions

Chemotherapy + Durvalumab

Group II: Arm 2Active Control2 Interventions

Chemotherapy alone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Cisplatin

2013

Completed Phase 3

~1940

Gemcitabine

2017

Completed Phase 3

~2070

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,262 Previous Clinical Trials

288,594,179 Total Patients Enrolled

Media Library

Durvalumab Clinical Trial Eligibility Overview. Trial Name: NCT03732677 — Phase 3

Bladder Cancer Research Study Groups: Arm 1, Arm 2

Bladder Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03732677 — Phase 3

Durvalumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03732677 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research only testing on individuals over the age of 30?

"This study is currently looking for volunteers that are between 18 and 130 years old."

Answered by AI

What is the present status of Durvalumab's FDA approval?

"Durvalumab was given a safety score of 3 by our analysts at Power. This is due to the fact that it is a Phase 3 trial, meaning there is both efficacy and safety data supporting its use."

Answered by AI

Who fits the screening criteria to join this clinical trial?

"This study needs 1063 individuals that have malignant neoplasms. The patients must also meet the following qualifications: between 18 and 130 years old, not having received prior systemic chemotherapy or immunotherapy for treatment of MIBC, resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology, planning to undergo a radical cystectomy, ECOG performance status of 0 or 1, life expectancy of at least 12 weeks at randomization, evidence of lymph node (N2-N3) or metastatic (M1) disease at time"

Answered by AI

What are the conditions that respond best to Durvalumab?

"Durvalumab is most often used to treat urinary bladder cancer. However, it has also been clinically shown to be effective at treating advanced testicular cancer, small cell lung cancer (sclc), and head and neck carcinoma."

Answered by AI

What is the history of Durvalumab in clinical research?

"City of Hope Comprehensive Cancer Center pioneered research on Durvalumab in 1997 and to date, there have been a total of 1711 clinical trials completed. As it stands, 1286 studies are actively recruiting patients with many of these based in Sherbrooke, Quebec."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

2018. "Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03732677.

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