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Chemotherapy

Chemotherapy + 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
Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Must not have
Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 60 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the efficacy of nivolumab plus neoadjuvant gemcitabine/cisplatin chemotherapy followed by post-surgery continuation of immuno-oncology therapy versus neoadjuvant gemcitabine/cisplatin chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer.

Who is the study for?
This trial is for adults with muscle-invasive bladder cancer who haven't had previous systemic therapy, radiation, or surgery (except certain biopsies and tumor resections). They must be fit enough for surgery as assessed by their doctors and have a performance status showing they can handle daily activities with ease or minor limitations.
What is being tested?
The study compares two approaches: one group receives chemotherapy drugs gemcitabine/cisplatin alone, while the other gets these chemo drugs plus Nivolumab. After surgery to remove the bladder, some participants will continue treatment with Nivolumab or Nivolumab combined with BMS-986205.
What are the potential side effects?
Nivolumab may cause immune-related side effects like inflammation in various organs including lungs and intestines, skin rash, hormone gland problems (like thyroid), fatigue, and infusion reactions. Chemotherapy can lead to nausea, hair loss, blood cell count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am approved for and agree to have bladder removal surgery after initial treatment.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to my lymph nodes or is metastatic bladder cancer.
Select...
I have only had TURBT or biopsies for my bladder cancer, no other treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-Free Survival (EFS), in all randomized participants
Pathological Complete Response (pCR) rate, in all randomized participants
Secondary study objectives
EFS, descriptively in all concurrently randomized participants
OS, descriptively in all concurrently randomized participants
Overall Survival (OS) in all randomized participants
+1 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Nivolumab + GC ChemotherapyExperimental Treatment3 Interventions
Group II: Arm A: Gemcitabine/Cisplatin (GC) ChemotherapyActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Nivolumab
2015
Completed Phase 3
~4010
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,210 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
174 Previous Clinical Trials
95,401 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03661320 — Phase 3
Bladder Cancer Research Study Groups: Arm B: Nivolumab + GC Chemotherapy, Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03661320 — Phase 3
Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03661320 — Phase 3
~34 spots leftby Apr 2025
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