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Alkylating agents

Nivolumab + Ipilimumab + Chemotherapy for Bladder Cancer(CheckMate901 Trial)

St Lukes Hospital, Saint Louis, MO
Nivolumab +4 morePhase 3Waitlist AvailableResearch Sponsored by Bristol-Myers Squibb

CheckMate901 Trial Summary

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

CheckMate901 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have no prior systemic chemotherapy for metastatic or surgically inoperable UC.
Select...
You have not received any chemotherapy treatment before for advanced or inoperable bladder cancer.

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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
10%
Alopecia
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
9%
Abdominal pain upper
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Embolism
2%
Cardiac failure
2%
Adrenal insufficiency
2%
Sepsis
2%
Malignant pleural effusion
1%
Circulatory collapse
1%
Pancytopenia
1%
Atrial flutter
1%
Lung cancer metastatic
1%
Cancer pain
1%
Syncope
1%
Pericardial effusion
1%
Colitis
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal haemorrhage
1%
Small intestinal obstruction
1%
Performance status decreased
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Confusional state
1%
Bronchial obstruction
1%
Pneumothorax
1%
Respiratory tract infection
1%
Respiratory failure
1%
Superior vena cava syndrome
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

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.

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
~4120
Ipilimumab
2014
Completed Phase 3
~2690
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
2,601 Previous Clinical Trials
4,046,400 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
152 Previous Clinical Trials
93,137 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the research history of Nivolumab?

"The first nivolumab clinical trial was hosted at City of Hope Comprehensive Cancer Center in 1997. A total of 2561 have been completed to date, with 2149 being active as of now. Many of these studies are based out of Halifax, Nova Scotia."

Answered by AI

Has Nivolumab received formal recognition by the FDA?

"Nivolumab's safety is supported by both efficacy data from Phase 3 trials as well as multiple rounds of dedicated safety studies--so we've given it a score of 3."

Answered by AI

What are the common functions of Nivolumab?

"Nivolumab's usual function is treating urinary bladder cancer, however it can also be effective in combating other forms of cancer such as small cell lung cancer and testicular cancerary bladder cancer, however it can also be effective in combating other forms of cancer such as small cell lung cancer and testicular cancer."

Answered by AI

Are investigators still looking for participants for this research project?

"That is correct. The listing on clinicaltrials.gov says that the trial team hopes to enroll 1307 patients at 29 sites around the country. This particular study was first posted on March 24th, 2017 and received its most recent update on November 3rd, 2022."

Answered by AI

How many individuals are actively involved in this research project at present?

"In order to carry out this experiment, the researchers need 1307 people that meet a set of specific inclusion criteria. The sponsor, Bristol-Myers Squibb, will be managing the trial from multiple locations including Nova Scotia Health Authority QEII Health Sciences Centre and Local Institution - 0052."

Answered by AI

How many different hospitals are participating in this trial?

"With 29 total sites, this clinical trial has many locations across North America including the Nova Scotia Health Authority QEII Health Sciences Centre in Halifax, Local Institution - 0052 in Sherbrooke, and Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center in Milford."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Nova Scotia Health Authority QEII Health Sciences Centre
What portion of applicants met pre-screening criteria?
Met criteria
~61 spots leftby Apr 2024