Nivolumab for Urothelial Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Urothelial Cancer
Nivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of an immunotherapy drug combo vs chemotherapy alone for treating urothelial cancer.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Urothelial Cancer

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: Up to 64 months

Up to 52 months
Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)
Up to 55 months
European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants
Overall survival (OS) in all randomized participants
Overall survival (OS) in cisplatin-ineligible randomized participants
Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants
Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants
Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants
Up to 64 months
European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC
Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC)
Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC)
Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Urothelial Cancer

Side Effects for

NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

4 Treatment Groups

Arm B: Standard of care chemotherapy
1 of 4
Arm D: Standard of care chemotherapy
1 of 4
Arm A: Investigational immunotherapy
1 of 4
Arm C: Investigational immunotherapy
1 of 4
Active Control
Experimental Treatment

1307 Total Participants · 4 Treatment Groups

Primary Treatment: Nivolumab · No Placebo Group · Phase 3

Arm A: Investigational immunotherapyExperimental Group · 2 Interventions: Nivolumab, Ipilimumab · Intervention Types: Biological, Biological
Arm C: Investigational immunotherapyExperimental Group · 3 Interventions: Cisplatin, Nivolumab, Gemcitabine · Intervention Types: Drug, Biological, Drug
Arm B: Standard of care chemotherapyActiveComparator Group · 3 Interventions: Carboplatin, Cisplatin, Gemcitabine · Intervention Types: Drug, Drug, Drug
Arm D: Standard of care chemotherapyActiveComparator Group · 2 Interventions: Cisplatin, Gemcitabine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Nivolumab
FDA approved
Gemcitabine
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 64 months

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,481 Previous Clinical Trials
3,918,565 Total Patients Enrolled
1 Trials studying Urothelial Cancer
66 Patients Enrolled for Urothelial Cancer
Ono Pharmaceutical Co. LtdIndustry Sponsor
148 Previous Clinical Trials
93,594 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must agree to follow specific methods of contraception, if applicable.
You have no prior systemic chemotherapy for metastatic or surgically inoperable UC.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Nova Scotia Health Authority QEII Health Sciences Centre100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%