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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
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

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%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
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%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Pericardial effusion malignant
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
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
2,650 Previous Clinical Trials
4,130,718 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
~22 spots leftby Jun 2025
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