Not provided
Not provided
Not provided
Not provided
Insufficient enrollment, inability to meet protocol objectives, and slow accrual.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: nivolumab + Bacillus Calmette-Guérin (BCG) | Experimental |
| |
| Arm B: placebo +BCG | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nivolumab | Drug | Specified Dose on Specified Days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Event Free Survival | The time between the date of randomization and the date of first documented event or death due to any cause, whichever occurs first. Events include recurrence of disease (TaHG, T1, or CIS) and progression of disease. Data Not Collected (DNC) | Approximately 44 Months and 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Worsening-Free Survival | The time from randomization to progression to muscle-invasive disease (ie, T2), cystectomy, systemic chemotherapy, radiotherapy, or death from any cause. Data Not Collected (DNC) | Approximately 44 months and 1 week |
| Part 2: Overall Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Of Chicago | Chicago | Illinois | 60637 | United States | ||
| Local Institution - 0084 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
Study terminated shortly after phase 1 (safety period), phase 2 efficacy period did not initiate.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months |
| FG001 | Arm B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
Specified Dose on Specified Days |
|
| Bacillus Calmette-Guérin (BCG) | Biological | Specified Dose on Specified Days |
|
The time between the date of randomization and the date of death due to any cause. For participants still alive, OS is censored at the last date the participant is known to be alive. Data Not Collected (DNC) |
| Approximately 44 months and 1 week |
| Part 2: Complete Response Rate at 13 Weeks | CRR is defined as the proportion of participants with CIS (+/- TaHG/T1) per PRC at randomization who are disease free at the first disease assessment (Week 13) Data Not Collected (DNC) | 13 Weeks |
| Part 2: Duration of Response | the time between the date of the first CR to the date of first documented recurrence, progression, or death due to any cause. Data Not Collected (DNC) | Approximately 44 months and 1 week |
| All-causality Adverse Events Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria. | 24.6 months |
| All-causality Adverse Events | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria. | 24.6 months |
| Drug-related Adverse Events | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria. | 24.6 months |
| The Bronx |
| New York |
| 10461 |
| United States |
| Local Institution - 0009 | Caba | Buenos Aires | 1426 | Argentina |
| Local Institution - 0088 | Capital Federal | Buenos Aires | 1419 | Argentina |
| Local Institution - 0016 | Ciudad Autonoma Beunos Aires | Buenos Aires | 1431 | Argentina |
| Local Institution - 0081 | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Local Institution - 0008 | Viedma | RÃo Negro Province | 8500 | Argentina |
| Local Institution - 0080 | Buenos Aires | 1120 | Argentina |
| Local Institution - 0107 | Córdoba | 5000 | Argentina |
| Local Institution - 0002 | Sydney | New South Wales | 2050 | Australia |
| Local Institution - 0001 | Woolloongabba | Queensland | 4012 | Australia |
| Local Institution - 0114 | Bowral | 2576 | Australia |
| Local Institution - 0097 | Linz | 4010 | Austria |
| Local Institution - 0104 | Salzburger | 5020 | Austria |
| Local Institution - 0099 | Vienna | 1090 | Austria |
| Local Institution - 0098 | Wels | 4600 | Austria |
| Local Institution - 0050 | Uberlândia | Minas Gerais | 38408-150 | Brazil |
| Local Institution - 0048 | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Local Institution - 0047 | Itajaà | Santa Catarina | 88301-220 | Brazil |
| Local Institution - 0049 | Rio de Janeiro | 22793-080 | Brazil |
| Local Institution - 0017 | Toronto | Ontario | M5G 1Z5 | Canada |
| Local Institution - 0038 | Montreal | Quebec | H2X 0C2 | Canada |
| Local Institution - 0037 | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution - 0012 | Rimouski | Quebec | G5L 5T1 | Canada |
| Local Institution - 0011 | La Serena | Coquimbo Region | 1720430 | Chile |
| Local Institution - 0010 | Recoleta | Santiago Metropolitan | 0 | Chile |
| Local Institution - 0072 | Viña del Mar | Valparaiso | 2520598 | Chile |
| Local Institution - 0042 | Angers | 49933 | France |
| Local Institution - 0106 | Dijon | 21079 | France |
| Local Institution - 0045 | Lille | 59000 | France |
| Local Institution - 0108 | Marseille | 13385 | France |
| Local Institution - 0111 | Paris | 75018 | France |
| Local Institution - 0103 | Paris | 75679 | France |
| Local Institution - 0041 | Strasbourg | FR-67091 | France |
| Local Institution - 0040 | Villejuif | 94800 | France |
| Local Institution - 0105 | Cologne | 50968 | Germany |
| Local Institution - 0094 | Herne | 44625 | Germany |
| Local Institution - 0093 | Jena | 07747 | Germany |
| Local Institution - 0095 | Trier | 54292 | Germany |
| Local Institution - 0031 | Haidari | 12462 | Greece |
| Local Institution - 0032 | Thessaloniki | 57001 | Greece |
| Local Institution - 0075 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Local Institution - 0073 | Jerusalem | 9103102 | Israel |
| Local Institution - 0074 | Ramat Gan | 52621 | Israel |
| Local Institution - 0067 | Torino | TO | 10126 | Italy |
| Local Institution - 0062 | Milan | 20133 | Italy |
| Local Institution - 0063 | Modena | 41124 | Italy |
| Local Institution - 0064 | Naples | 80131 | Italy |
| Local Institution - 0065 | Reggio Emilia | 42100 | Italy |
| Local Institution - 0066 | Roma | 00168 | Italy |
| Local Institution - 0054 | Arnhem | 6815 AD | Netherlands |
| Local Institution | Rotterdam | 3015 GD | Netherlands |
| Local Institution - 0051 | Moscow | 121309 | Russia |
| Local Institution - 0052 | Saint Petersburg | 199034 | Russia |
| Local Institution - 0096 | Pamplona | Navarre | 31008 | Spain |
| Local Institution - 0061 | Badajoz | 06006 | Spain |
| Local Institution - 0060 | Badalona-barcelona | 08916 | Spain |
| Local Institution - 0055 | Madrid | 28041 | Spain |
| Local Institution - 0059 | Sabadell | 08208 | Spain |
| Local Institution - 0057 | Santander | 39008 | Spain |
| Local Institution - 0058 | Valencia | 46010 | Spain |
| Local Institution - 0087 | Norrköping | 601 82 | Sweden |
| Local Institution - 0083 | Umeå | 901 85 | Sweden |
Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months |
| BG001 | Arm B | Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 2: Event Free Survival | The time between the date of randomization and the date of first documented event or death due to any cause, whichever occurs first. Events include recurrence of disease (TaHG, T1, or CIS) and progression of disease. Data Not Collected (DNC) | Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion). | Posted | Approximately 44 Months and 1 Week |
|
| ||||||||||||||||||||||
| Secondary | Part 2: Worsening-Free Survival | The time from randomization to progression to muscle-invasive disease (ie, T2), cystectomy, systemic chemotherapy, radiotherapy, or death from any cause. Data Not Collected (DNC) | Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion). | Posted | Approximately 44 months and 1 week |
|
| ||||||||||||||||||||||
| Secondary | Part 2: Overall Survival | The time between the date of randomization and the date of death due to any cause. For participants still alive, OS is censored at the last date the participant is known to be alive. Data Not Collected (DNC) | Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion). | Posted | Approximately 44 months and 1 week |
|
| ||||||||||||||||||||||
| Secondary | Part 2: Complete Response Rate at 13 Weeks | CRR is defined as the proportion of participants with CIS (+/- TaHG/T1) per PRC at randomization who are disease free at the first disease assessment (Week 13) Data Not Collected (DNC) | Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion). | Posted | 13 Weeks |
|
| ||||||||||||||||||||||
| Secondary | Part 2: Duration of Response | the time between the date of the first CR to the date of first documented recurrence, progression, or death due to any cause. Data Not Collected (DNC) | Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion). | Posted | Approximately 44 months and 1 week |
|
| ||||||||||||||||||||||
| Secondary | All-causality Adverse Events Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria. | All treated participants | Posted | Count of Participants | Participants | 24.6 months |
|
| ||||||||||||||||||||
| Secondary | All-causality Adverse Events | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria. | All treated participants | Posted | Count of Participants | Participants | 24.6 months |
|
| ||||||||||||||||||||
| Secondary | Drug-related Adverse Events | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria. | All treated participants | Posted | Count of Participants | Participants | 24.6 months |
|
|
Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months | 0 | 8 | 2 | 8 | 5 | 8 |
| EG001 | Arm B | Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months | 0 | 4 | 0 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Dyschezia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 26.1 | Systematic Assessment |
| |
| Pain | General disorders | 26.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 26.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.1 | Systematic Assessment |
| |
| Cortisol decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Immune-mediated cystitis | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | 26.1 | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | 26.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | 26.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | 1-855-907-3286 | Clinical.Trials@bms.com |
| Oct 8, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|