← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 64 months
Awards & highlights

CheckMate901 Trial 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.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.

CheckMate901 Trial 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.

CheckMate901 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 64 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 64 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)
Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
Overall survival (OS) in cisplatin-ineligible randomized participants
+1 more
Secondary outcome measures
European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants
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)
+5 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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

CheckMate901 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
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,129,542 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,233 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
~57 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top