Comparing 3 approaches for superficial bladder cancer
Official title: LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment
- Phase 1
- 3 groups
- Sites in Calgary, Vancouver and 3 more cities
- Recruiting
Interventions
- Medication
EG-70 (phase 1)
Patients will receive up to four cycles of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes.One cycle lasts approximately 12 weeks and consists of either a 2-dose (Day 1 and Day 8) or 4-dose (Day 1, Day 8, Day 29 and Day 36) regimen.
- Medication
EG-70 (phase 2) Master Protocol
Under the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles, of EG-70 at the RP2D defined in Phase 1, administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle lasts approximately 12 weeks. For Maintenance treatment 2 doses of EG-70 will be administered as a bladder instillation per 12-week cycle.
- Medication
Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
Patients will receive via catheter a 50 mL volume of a 5-minute bladder rinse immediately prior to administration of 50 mL of detalimogene voraplasmid (EG-70) at the RP2D for 30 minutes. During the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles of the sudy intervention. One cycle lasts approximately 12 weeks. For Maintenance treatment, 2 doses of the study intervention will be administered as a bladder instillation per 12-week cycle.
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
Prostate Cancer Centre
Calgary, Alberta
- Recruiting
Vancouver Prostate Centre
Vancouver, British Columbia
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia
- Recruiting
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario
- Recruiting
McGill University Health Center - Glen site
Montreal, Quebec
- Recruiting
CHUM Centre Hospitalier de l Universite de Montreal
Montreal, Quebec
Eligibility Criteria
See who this study is looking for36 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Must have satisfactory bladder function with ability to retain study drug for 60 minutes.
- +BCG-unresponsive Patients:
- +BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without coexisting papillary Ta/T1 tumors who are ineligible for or have elected not to undergo cystectomy, and have experienced CIS disease within 12 months of treatment where: adequate BCG regimen consists of at least 2 courses of BCG where the first course (induction) must have included at least 5 or 6 doses and the second course may have included a re-induction (at least 2 treatments) or maintenance (at least 2 doses), and Cis must be documented or indicated by pathology
- +Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → Only:
- +BCG-Naïve or BCG-incompletely treated Patients with CIS or BCG-unresponsive, HG Ta/T1 papillary disease without CIS:
- +All Patients with High Grade NMIBC:
- +Patients who have previously been treated with a checkpoint inhibitor and failed treatment are eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → 30 days post-treatment (Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →) or 3 months post-treatment (Phase 2).
- +In Phase 2, for patients with T1 lesions may be eligible after repeat TURBT if pathology shows non-invasive (Ta or less) or no disease.
- +Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.
- +Hematologic inclusion: a. Absolute neutrophil count \>1,500/mm3. b. Hemoglobin \>9.0 g/dL. c. Platelet count \>100,000/mm3.
- +Hepatic inclusion: a. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN). b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤2.5 x ULN.
- +Adequate renal function with creatinine clearance \>30 mL/min
- +Prothrombin time and partial thromboplastin time ≤1.25 x ULN or within the therapeutic range if on anticoagulation therapy.
- +Male or non-pregnant, non-lactating female, 18 years or older.
- +Women of childbearing potential must have a negative pregnancy test at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Female patients of childbearing potential must be willing to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to using highly effective birth controlControl groupThe group a new treatment is measured against.Read more → methods; Male patients are required to utilize a condom for the duration of the study treatment through 3 months post-dose.
- +NMIBC with current Cis of the bladder, with or without coexisting papillary Ta/T1 NMIBC tumor(s), who are ineligible for or have elected not to undergo cystectomy, where: either: cohortCohortA group of participants sharing a characteristic, followed together.Read more → 2a) no treatment with BCG but may have previously been treated with at least 1 dose of intravesical chemotherapy following transurethral resection of bladder tumor (TURBT) and Cis must be documented or cohort 2b) indicated by pathology incomplete BCG treatment (at least 1 dose and less than the 5+2 doses required for adequate dosing per Cohort 1) or cohort 3) patients who are BCG-unresponsive following adequate treatment, with HG Ta/T1 papillary disease without CIS.
Exclusion
- −Hypersensitivity to any of the excipients of the study drug.
- −Exclusionary for Bladder Rinse cohortsCohortA group of participants sharing a characteristic, followed together.Read more →: known allergy to polidocanol
- −Known human immunodeficiency virus, Hepatitis B, or Hepatitis C infection.
- −Active malignancies (i.e., progressing or requiring treatment change in the last 24 months). Exceptions allowed under SponsorSponsorThe organisation responsible for the study overall.Read more → review.
- −Concurrent treatment with any chemotherapeutic agent.
- −History of partial cystectomy.
- −Patients who have received systemic immunosuppressive medication including high-dose corticosteroids.
- −History of severe asthma or other respiratory diseases.
- −History of unresolved vesicoureteral reflux or an indwelling urinary stent.
- −History of unresolved hydronephrosis due to ureteral obstruction.
- −History of interstitial lung disease and/or pneumonitis in patients who have previously received a PD-1 or PD-L1 inhibitor therapy.
- −Evidence of metastatic disease.
- −History of difficult catheterization that in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → will prevent administration of EG-70.
- −Active interstitial cystitis on cystoscopy or biopsy.
- −Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- −Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months).
- −Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → (prior to the screening biopsy).
- −Participation in any other research protocolProtocolThe detailed plan a study must follow.Read more → involving administration of an investigational agent within 30 Days prior to screening or any prior treatment of NMIBC with any investigational gene or immunotherapy agent.
- −History of external beam radiation to the pelvis or prostate brachytherapy within the last 12 months.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives EG-70 (phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →).
Registry label: A: Phase 1
Group B receives EG-70 (phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →) Master ProtocolProtocolThe detailed plan a study must follow.Read more →.
Registry label: B: Phase 2
Group C receives Surfactant Bladder Pre-Rinse and EG-70 (Substudy).
Registry label: C: Phase 1 Substudy Surfactant Bladder Rinse
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 350 people.
The study is currently expected to finish around October 2030.
The main measurement is taken over: Approximately 2 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0 — measured over Approximately 2 years.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →: Percentage of patients with cystoscopic CR at any time, based on exam, urine cytology and appropriate biopsies — measured over Approximately 24 weeks.
Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (as assessed by CTCAE v5.0) — measured over Approximately 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04752722 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About EG-70 (phase 1)Drug
Patients will receive up to four cycles of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes.One cycle lasts approximately 12 weeks and consists of either a 2-dose (Day 1 and Day 8) or 4-dose (Day 1, Day 8, Day 29 and Day 36) regimen.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About EG-70 (phase 2) Master ProtocolDrug
Under the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles, of EG-70 at the RP2D defined in Phase 1, administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle lasts approximately 12 weeks. For Maintenance treatment 2 doses of EG-70 will be administered as a bladder instillation per 12-week cycle.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Surfactant Bladder Pre-Rinse and EG-70 (Substudy)Drug
Patients will receive via catheter a 50 mL volume of a 5-minute bladder rinse immediately prior to administration of 50 mL of detalimogene voraplasmid (EG-70) at the RP2D for 30 minutes. During the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles of the sudy intervention. One cycle lasts approximately 12 weeks. For Maintenance treatment, 2 doses of the study intervention will be administered as a bladder instillation per 12-week cycle.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Approximately 2 years.
The study as a whole is currently expected to finish around 2030-10-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 350 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Detroit, Michigan, United States, and 8 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with: NMIBC with CIS for whom BCG therapy is unresponsive, and other high risk patients with NMIBC. A Substudy will include a surfactant bladder rinse prior to the instillation of detalimogene in patients with NMIBC with CIS for whom BCG therapy is unresponsive.
Other Sites (9)
Henry Ford Health System
Detroit, Michigan, United States
Corewell Health Medical Group and Spectrum Health Hospitals
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Albany Medical College
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Mount Sinai Medical Center
New Haven, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Associated Medical Professionals of NY,
Syracuse, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.