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Alkylating agents

Immunotherapy Combo vs Chemotherapy for Bladder Cancer (CheckMate901 Trial)

Saint Louis, MO
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
No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)
Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra
Must not have
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Disease that is suitable for local therapy administered with curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

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

See full description
Who is the study for?
This trial is for adults with untreated inoperable or metastatic bladder cancer. Participants should be relatively fit (ECOG status 0 or 1), have not had chemotherapy for this condition, and must agree to use contraception if applicable. Those with serious medical issues, previous treatments targeting immune checkpoints, or who are candidates for curative local therapy cannot join.Check my eligibility
What is being tested?
The study tests the effectiveness of Nivolumab combined with Ipilimumab or standard chemotherapy (Gemcitabine plus Cisplatin/Carboplatin) against standard chemotherapy alone in treating advanced bladder cancer. The goal is to see which treatment helps more.See study design
What are the potential side effects?
Nivolumab and Ipilimumab can cause immune-related side effects like inflammation in various organs, skin rash, hormone gland problems, and flu-like symptoms. Chemotherapy may lead to nausea, fatigue, hair loss, kidney damage (with Cisplatin), and lower blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had chemotherapy for advanced or inoperable bladder cancer.
 show original
Select...
My cancer, which started in the urinary system, cannot be removed by surgery.
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Select...
I am fully active or have some restrictions but can still care for myself.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have previously received treatments targeting immune checkpoints.
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Select...
My condition can be treated with the goal of curing it.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
70%
Fatigue
50%
Headache
45%
Confusional state
45%
Cough
40%
Malignant neoplasm progression
35%
Hemiparesis
35%
Diarrhoea
30%
Gait disturbance
30%
Nausea
30%
Pruritus
25%
Urinary tract infection
25%
Fall
25%
Hyperglycaemia
25%
Muscular weakness
25%
Rash
20%
Constipation
20%
Vomiting
20%
Lethargy
20%
Memory impairment
20%
Urinary incontinence
20%
Dizziness
20%
Nasal congestion
15%
Abdominal pain
15%
Alanine aminotransferase increased
15%
Lymphocyte count decreased
15%
Platelet count decreased
15%
Decreased appetite
15%
Arthralgia
15%
Cognitive disorder
10%
Aspartate aminotransferase increased
10%
Oedema peripheral
10%
Facial paresis
10%
Pyrexia
10%
Candida infection
10%
Depressed level of consciousness
10%
Syncope
10%
Pulmonary embolism
10%
Anaemia
10%
Sinus tachycardia
10%
Anal incontinence
10%
Asthenia
10%
Tooth infection
10%
Upper respiratory tract infection
10%
Lipase increased
10%
Paraesthesia
10%
Psychomotor skills impaired
10%
Seizure
10%
Agitation
10%
Anxiety
10%
Disorientation
10%
Dehydration
10%
Hypoalbuminaemia
10%
Hypokalaemia
10%
Hyponatraemia
10%
Aphasia
10%
Dysarthria
10%
Dyspnoea
10%
Rash maculo-papular
5%
Dermatitis acneiform
5%
Dysphagia
5%
Oedema
5%
Pain
5%
Cardio-respiratory arrest
5%
Autoimmune thyroiditis
5%
Pneumonia
5%
Hip fracture
5%
White blood cell count decreased
5%
Enterocolitis infectious
5%
Tumour flare
5%
Brain oedema
5%
Cerebrovascular accident
5%
Ischaemic stroke
5%
Mental status changes
5%
Aspiration
5%
Herpes zoster
5%
Haemorrhage intracranial
5%
Hypoxia
5%
Pneumonitis
5%
Respiratory distress
5%
Atrial fibrillation
5%
Cushingoid
5%
Hyperthyroidism
5%
Hypothyroidism
5%
Dry eye
5%
Eyelid ptosis
5%
Visual field defect
5%
Visual impairment
5%
Dyspepsia
5%
Oral candidiasis
5%
Stomatitis
5%
Chills
5%
Amylase increased
5%
Blood alkaline phosphatase increased
5%
Blood bilirubin increased
5%
Weight decreased
5%
Weight increased
5%
Tremor
5%
Vasogenic cerebral oedema
5%
Depression
5%
Insomnia
5%
Pollakiuria
5%
Hypocalcaemia
5%
Proteinuria
5%
Back pain
5%
Myalgia
5%
Amnesia
5%
Ataxia
5%
Balance disorder
5%
Dysphonia
5%
Dry skin
5%
Deep vein thrombosis
5%
Hypertension
5%
Hypotension
5%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1b: Arm N3+I1
Cohort 1: Arm N3
Cohort 1: Arm N1+I3
Cohort 2: Arm N3
Part A Cohort 1c: Arm N3+RT+TMZ
Cohort 2: Arm B
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Part A Cohort 1d: Arm N3+RT

Awards & Highlights

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.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm C: Investigational immunotherapyExperimental Treatment3 Interventions
Group II: Arm A: Investigational immunotherapyExperimental Treatment2 Interventions
Group III: Arm B: Standard of care chemotherapyActive Control3 Interventions
Group IV: Arm D: Standard of care chemotherapyActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3040
Nivolumab
2014
Completed Phase 3
~3880
Ipilimumab
2015
Completed Phase 3
~3380
Gemcitabine
2017
Completed Phase 3
~1320

Find a Location

Closest Location:St Lukes Hospital· Saint Louis, MO

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,730 Previous Clinical Trials
4,127,781 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
181 Previous Clinical Trials
95,759 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03036098 — Phase 3
Bladder Cancer Research Study Groups: Arm A: Investigational immunotherapy, Arm B: Standard of care chemotherapy, Arm C: Investigational immunotherapy, Arm D: Standard of care chemotherapy
Bladder Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03036098 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03036098 — Phase 3
~147 spots leftby Mar 2026
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