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Immunostimulant

Nivolumab for Bladder Cancer

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cisplatin-ineligible participants will be defined by any one of the following criteria:
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 43 months
Awards & highlights

Study Summary

This trial is testing whether two immunotherapy drugs or one immunotherapy drug plus surgery is more effective than surgery alone in treating participants with high-risk urothelial cancer who cannot receive cisplatin chemotherapy.

Eligible Conditions
  • Bladder Cancer
  • Bladder Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You cannot receive cisplatin as a treatment option if you meet any of the following criteria:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 43 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 43 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) of Arm A vs Arm C
Pathologic Complete Response (pCR) rate of Arm A to Arm C
Secondary outcome measures
EFS of Arm A vs Arm B
EFS of Arm B vs Arm C
Incidence of AEs leading to discontinuation
+7 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%
Blood alkaline phosphatase increased
7%
Dehydration
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%
Hypercalcaemia
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%
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

3Treatment groups
Experimental Treatment
Group I: Arm C: Standard-of-careExperimental Treatment1 Intervention
RC alone, without neoadjuvant or adjuvant therapy
Group II: Arm B: MonotherapyExperimental Treatment2 Interventions
Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab
Group III: Arm A: Combination TherapyExperimental Treatment3 Interventions
Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Radical cystectomy (RC)
2020
Completed Phase 3
~120
Bempegaldesleukin
2020
Completed Phase 3
~380

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsIndustry Sponsor
58 Previous Clinical Trials
10,228 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,400 Total Patients Enrolled

Media Library

Bempegaldesleukin (Immunostimulant) Clinical Trial Eligibility Overview. Trial Name: NCT04209114 — Phase 3
Bladder Cancer Research Study Groups: Arm B: Monotherapy, Arm C: Standard-of-care, Arm A: Combination Therapy
Bladder Cancer Clinical Trial 2023: Bempegaldesleukin Highlights & Side Effects. Trial Name: NCT04209114 — Phase 3
Bempegaldesleukin (Immunostimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209114 — Phase 3

Frequently Asked Questions

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

Does Nivolumab carry a high risk for serious side effects?

"Nivolumab has been deemed safe by our team at Power. This is due to the fact that Nivolumab is a Phase 3 trial, meaning that not only is there some data supporting efficacy, but multiple rounds of data supporting safety."

Answered by AI

In how many different medical facilities is this research being conducted today?

"34 hospitals around the world are participating in this clinical trial, including Banner MD Anderson Cancer Center in Gilbert, Arizona, Local Institution - 0082 in Oshawa, Ontario, and Rutgers Cancer Institute of New jersey in New Brunswick, New Jersey."

Answered by AI

Are there any vacancies in this study for potential participants?

"This study has already wrapped up recruitment for participants. The trial was first posted on February 5th, 2020 and was most recently edited on October 10th, 2022. If you are looking for other studies, 391 clinical trials for patients with muscle-invasive bladder cancer and 753 studies for Nivolumab are currently recruiting."

Answered by AI

Could you please tell us if Nivolumab has been studied before?

"Out of the 753 ongoing studies involving Nivolumab, 83 are in Phase 3. The global locations conducting these trials number 40502, with many of them situated in São Paulo and Maryland."

Answered by AI

Why is Nivolumab commonly given to patients?

"Nivolumab is used to treat malignant neoplasms and other conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

How many volunteers are included in this experiment?

"This particular trial is no longer taking patients. The trial began on 2020-02-05 and ended on 2022-10-10. However, there are currently 391 trials for muscle-invasive bladder cancer and 753 trials for Nivolumab that are actively recruiting participants."

Answered by AI

Has a trial like this been conducted before?

"Nivolumab has a long history, with the first clinical trial being conducted in 2010. The original study was sponsored by Medarex and only involved 127 patients. Phase 1 drug approval was given to Nivolumab in 2010. Currently, there are 753 active studies being conducted in 2357 cities and 50 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
2020. "A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04209114.
~22 spots leftby Apr 2025
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