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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 below

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I am approved for and agree to have bladder removal surgery after initial treatment.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 60 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

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 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%

Rash

14%

Hyponatraemia

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%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Dehydration

Hyperkalaemia

Hyperglycaemia

Chills

Blood alkaline phosphatase increased

Hypertension

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Femur fracture

Pericardial effusion malignant

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Neoplasm progression

Atrial flutter

Bronchial obstruction

Hypercalcaemia

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,127,653 Total Patients Enrolled

Ono Pharmaceutical Co. LtdIndustry Sponsor

154 Previous Clinical Trials

93,662 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03661320 — Phase 3

Bladder Cancer Research Study Groups: Arm B: Nivolumab + GC Chemotherapy, Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy

Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03661320 — Phase 3

Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03661320 — Phase 3

Frequently Asked Questions

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

Could you tell me how many test locations are participating in this research?

"This trial is running in 32 locations, which are primarily situated in Midwestern cities such as Chicago, Charleston and Omaha. If you're interested in participating, try to select a site that's close to minimize travel requirements."

Answered by AI

What are the effects of BMS-986205 on patients?

"BMS-986205 can not only be used to treat advanced testicular cancer, but also sclc, malignant neoplasms, and unresectable melanoma."

Answered by AI

Does BMS-986205 pose any risks to human health?

"BMS-986205 safety is estimated to be a 3. This clinical grade indicates that while Phase 3 data supporting efficacy exists, multiple rounds of safe testing have been completed."

Answered by AI

Are there any other examples of BMS-986205 being used in a research setting?

"There are a total of 1702 BMS-986205 clinical trials currently underway, with 415 of them in Phase 3. This global treatment is being tested at 85262 sites, many of which are based in Shanghai."

Answered by AI

Recent research and studies

Future OncologyJournal

ENERGIZE: A Phase III Study of Neoadjuvant Chemotherapy Alone or with Nivolumab With/without Linrodostat Mesylate for Muscle-invasive Bladder Cancer

Sonpavde, Guru, Andrea Necchi, Shilpa Gupta, Gary D Steinberg, Juergen E Gschwend, Michiel Simon Van Der Heijden, Nathalie Garzon, et al.. 2020. “ENERGIZE: A Phase III Study of Neoadjuvant Chemotherapy Alone or with Nivolumab With/without Linrodostat Mesylate for Muscle-invasive Bladder Cancer”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2019-0611.

clinicaltrials.govStudy

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

2018. "A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03661320.

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