← Back to Search

Checkpoint Inhibitor

Nivolumab for Bladder Cancer

Phase 2
Waitlist Available
Led By Ulka N. Vaishampayan, M.D.
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration to death or last follow up, assessed up to 36 months
Awards & highlights

Study Summary

This trial tests whether nivolumab, given with radiation therapy, can shrink tumors in patients with urothelial bladder cancer that has spread to nearby tissues or lymph nodes.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to death or last follow up, assessed up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to death or last follow up, assessed up to 36 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
Progression-free Survival (PFS)
Secondary outcome measures
Metastasis-free Survival (MFS)
Overall Response Rate (ORR)
Overall Survival (OS)
+3 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%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, radiation therapy)Experimental Treatment2 Interventions
Given IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Radiation
2003
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,266 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,494 Total Patients Enrolled
Ulka N. Vaishampayan, M.D.Principal InvestigatorBarbara Ann Karmanos Cancer Institute
3 Previous Clinical Trials
85 Total Patients Enrolled

Frequently Asked Questions

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

What is the aggregate number of individuals engaged in this research?

"At present, this research endeavour is not accepting volunteers. The trial was initially advertised on the 24th of April 2018 and underwent its most recent update at 15th April 2022. If you are looking to participate in other studies, there are currently 2730 clinical trials related to urinary bladder cancer actively recruiting patients as well as 718 Nivolumab-centred investigations also searching for participants."

Answered by AI

What potential risks are associated with Nivolumab treatment?

"Our analysts at Power gave Nivolumab a rating of 2 based on the Phase 2 trial findings, which signify that there is some data suggesting its safety but no proof yet regarding its efficacy."

Answered by AI

Has this experimental endeavor been previously undertaken?

"Ever since 2012, Nivolumab has been the subject of research. The initial trial was conducted by Ono Pharmaceutical Co. Ltd and included 659 participants—leading to Phase 1 & 2 approval. Presently, there are 718 active studies taking place in 49 countries and 2356 cities around the world."

Answered by AI

How has Nivolumab been employed to assist patients?

"Nivolumab is a viable therapeutic option for individuals struggling with malignant neoplasms, inoperable melanoma, and squamous cell carcinoma."

Answered by AI

Has there been any previous research conducted regarding Nivolumab?

"Nivolumab was initially explored in 2012 by Local Institution, and since then 320 studies have been concluded. There are now 718 active trials of nivolumab being conducted, with a significant proportion taking place at Buffalo, New york."

Answered by AI

Are there any open positions left for participants in this research trial?

"As of this moment, the clinical trial is not recruiting patients. Initially posted on April 24th 2018 and most recently modified on April 15th 2022, it has been suspended for enrolment. If you are looking for alternatives, 2730 trials examining urinary bladder cancer and 718 investigating Nivolumab are currently registering participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo
Nitin Vaishampayan, MD 2018. "Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03421652.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top