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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 60 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 60 months
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), in all randomized participants
Pathological Complete Response (pCR) rate, in all randomized participants
Secondary outcome measures
EFS, descriptively in all concurrently randomized participants
Incidence of Adverse Events (AE) in participants who received at least one treatment dose
Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose
+5 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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
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
~1940
Nivolumab
2014
Completed Phase 3
~4750
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,129,971 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,662 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my lymph nodes or is metastatic bladder cancer.I have only had TURBT or biopsies for my bladder cancer, no other treatments.I am approved for and agree to have bladder removal surgery after initial treatment.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Nivolumab + GC Chemotherapy
- Group 2: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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