← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient safety will be evaluated throughout the treatment period and follow up (treatment with nivolumab is expected to last 1 year for each patient and follow up for 2 years)
Awards & highlights

NEXT Trial 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.Check my eligibility
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.See study design
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.

NEXT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery to remove part of my bladder due to cancer before starting chemoradiation.
Select...
I am using two birth control methods or am not able to have children, and will continue for 5 months after the study.
Select...
My cancer originates from the bladder, urethra, or lower ureter.
Select...
I've had chemotherapy combined with radiation therapy targeting the pelvic area.
Select...
I may or may not have had platinum-based chemotherapy before chemoradiation.
Select...
I can perform daily activities with minimal assistance.
Select...
I am 18 years old or older.
Select...
My blood tests show normal white blood cells, neutrophils, and hemoglobin levels.
Select...
My kidneys are functioning well enough, as per a specific test.
Select...
All my side effects from cancer treatment have mostly gone, except for possible kidney issues, nerve pain, hearing loss, hair loss, or tiredness.
Select...
I have taken a pregnancy test within the last 72 hours and it was negative.
Select...
I can begin the study treatment within 90 days after finishing chemoradiation.
Select...
I agree to use birth control from the start of the study until 7 months after it ends.
Select...
My bladder cancer is at a stage where surgery to remove it isn't an option for me.

NEXT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient safety will be evaluated throughout the treatment period and follow up (treatment with nivolumab is expected to last 1 year for each patient and follow up for 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and patient safety will be evaluated throughout the treatment period and follow up (treatment with nivolumab is expected to last 1 year for each patient and follow up for 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Two-year rate of failure-free survival (FFS)
Secondary outcome measures
Cystoscopic Local Control
Effect of treatment on Quality of Life
Overall Survival
+5 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

NEXT 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
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,088 Previous Clinical Trials
1,728,149 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,047 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

Frequently Asked Questions

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

Are there any open vacancies for this research project?

"This study, which was first advertised on clinicaltrials.gov on 7/10/2017, is currently seeking participants for the trial."

Answered by AI

What are Nivolumab's most common indications?

"Nivolumab can be used to help fight various types of cancer such as malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Does Nivolumab have a lot of negative side effects?

"Nivolumab's safety is estimated to be a 2. Although there is some data suggesting it is safe, as this is only a Phase 2 trial, there is no evidence yet that the medication is effective."

Answered by AI

Has anything like this been done before?

"Nivolumab clinical trials began a decade ago in 2010. Medarex, the pharmaceutical company sponsoring the research, recruited 127 patients for their initial Phase 1 trial. Nivolumab was approved for use after this first study and there are now747 active studies involving this drug taking place across 2347 cities and 50 countries."

Answered by AI

So far, how many people have signed up to participate in this research project?

"That is correct, the information available on clinicaltrials.gov indicates that this study wants more participants. The trial was first advertised on 7/10/2017 and was updated as recently as 7/19/2022. They are seeking a total of 28 individuals from 2 distinct locations."

Answered by AI

What does the research say about Nivolumab's efficacy?

"There are currently 747 ongoing studies involving Nivolumab, with the majority of them being Phase 3 trials. Most of these clinical investigations are happening in Basel, BE; however, there are a total of 40325 locations where Nivolumab trials are taking place."

Answered by AI
~12 spots leftby Sep 2024