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Alkylating agents

Immunotherapy Combo vs Chemotherapy for Bladder Cancer (CheckMate901 Trial)

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.

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.
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.
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
Select...
I have not had chemotherapy for advanced or inoperable bladder cancer.
Select...
My cancer, which started in the urinary system, cannot be removed by surgery.
Select...
I am fully active or have some restrictions but can still care for myself.

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.
Select...
My condition can be treated with the goal of curing it.

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
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

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
~3120
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3070
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,128,247 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
171 Previous Clinical Trials
94,414 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
~154 spots leftby Nov 2025
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