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Nivolumab for Bladder Cancer (NEXT Trial)

Phase 2
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have undergone partial cystectomy for removal of bladder tumor prior to chemoradiation
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication
Must not have
Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
Evidence of distant metastases or lymph node metastasis (es) that was not within the radiation field
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combining chemotherapy, radiation, and immunotherapy. The goal is to see if this new treatment can help people with bladder cancer live cancer-free for longer.

Who is the study for?
Adults with localized muscle-invasive bladder cancer stages T2-4b, N0/N+, M0 or T1 with N+ who've had chemoradiation and can't have radical cystectomy. Must be ≥18 years old, ECOG ≤2, adequate organ function, no distant metastases/active malignancies/autoimmune diseases/HIV/hepatitis. Women must not be pregnant and agree to contraception.
What is being tested?
This phase 2 trial tests if the drug Nivolumab improves failure-free survival over two years in adults after chemoradiation for bladder cancer. It's a single-arm study where all participants receive the same treatment without comparison to a placebo or other therapy.
What are the potential side effects?
Nivolumab may cause immune-related side effects like inflammation of organs (colitis, hepatitis), skin problems (rash), endocrine issues (thyroid dysfunction), lung inflammation (pneumonitis) and infusion reactions. Fatigue is also common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery to remove part of my bladder due to cancer before starting chemoradiation.
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I am using two birth control methods or am not able to have children, and will continue for 5 months after the study.
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My cancer originates from the bladder, urethra, or lower ureter.
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I've had chemotherapy combined with radiation therapy targeting the pelvic area.
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I can perform daily activities with minimal assistance.
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I am 18 years old or older.
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My blood tests show normal white blood cells, neutrophils, and hemoglobin levels.
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My kidneys are functioning well enough, as per a specific test.
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All my side effects from cancer treatment have mostly gone, except for possible kidney issues, nerve pain, hearing loss, hair loss, or tiredness.
Select...
My bladder cancer is at a stage where surgery to remove it isn't an option for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.
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My cancer has spread to areas not treated by radiation.
Select...
I have inflammatory bowel disease.
Select...
I have another cancer that is getting worse or needs treatment.
Select...
My bladder cancer has spread too widely to be targeted by a focused radiation treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Two-year rate of failure-free survival (FFS)
Secondary study objectives
Cystoscopic Local Control
Overall Survival
Rate of distant failure free survival
+3 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab, all patientsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,145 Previous Clinical Trials
1,698,637 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,691 Previous Clinical Trials
4,097,388 Total Patients Enrolled

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT03171025 — Phase 2
Bladder Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03171025 — Phase 2
Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03171025 — Phase 2
Bladder Cancer Research Study Groups: Nivolumab, all patients
~24 spots leftby Dec 2025
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