At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- EG-70 (phase 1) (drug), EG-70 (phase 2) Master Protocol (drug), Surfactant Bladder Pre-Rinse and EG-70 (Substudy) (drug)
- How long the study runs
- Study runs about 114 months (dates as stated)
- About the drug or intervention
- 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. · EG-70 (phase 2) Master Protocol — drug: 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. · 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.
- Patient visit burden
- Not specified by the sponsor
In plain English
The LEGEND Study is testing a new treatment called EG-70 for people with non-muscle invasive bladder cancer (NMIBC), which is cancer in the inner layers of the bladder that has not spread into the muscle. It includes people whose cancer did not respond to BCG (a standard bladder cancer treatment given directly into the bladder), as well as some who have never had BCG or did not finish a full course. EG-70 is given through a tube (catheter) into the bladder, and patients need to be able to hold it in the bladder for 60 minutes.
Who can take part
- Adults aged 18 or over, male or female (women must not be pregnant or breastfeeding, and a pregnancy test is needed at screening for women who can become pregnant).
- People with high-grade non-muscle invasive bladder cancer, including a type called carcinoma in situ (CIS), which may be with or without papillary tumours (Ta/T1).
- People whose cancer did not respond to BCG treatment (called BCG-unresponsive) after at least two proper courses of BCG, who cannot have or have chosen not to have surgery to remove the bladder (cystectomy).
- In Phase 2 only: people who have never had BCG, or who had an incomplete course of BCG, with CIS; and people who are BCG-unresponsive with high-grade Ta/T1 papillary disease without CIS.
- People who have already tried a checkpoint inhibitor (a type of immunotherapy) that did not work, as long as enough time has passed since that treatment (30 days in Phase 1, 3 months in Phase 2).
- Reasonably fit and well day-to-day (performance status score of 0, 1 or 2), with healthy enough blood, liver, kidney and blood-clotting test results.
- Able to hold the study drug in the bladder for 60 minutes.
- In Phase 2, people with T1 tumours may join after a repeat TURBT (an operation to remove bladder tumours) if follow-up tests show the disease is non-invasive or gone.
- Agreement to use highly effective contraception: women who can become pregnant must use effective birth control; men must use condoms during treatment and for 3 months after the last dose.
Who may not be able to
- Another cancer that is active or needed a change of treatment in the last 24 months (exceptions may be allowed).
- Currently having chemotherapy.
- Previous surgery to remove part of the bladder.
- Cancer treatment (including chemotherapy placed in the bladder after tumour removal) within 30 days before screening.
- Taking medicines that suppress the immune system, including high-dose steroids.
- History of severe asthma or other serious lung disease.
- Ongoing urine flowing backwards from the bladder to the kidneys (vesicoureteral reflux), or a stent left in the urinary system.
- Ongoing kidney swelling caused by a blocked ureter (the tube from kidney to bladder).
- Taking part in another study drug trial within the last 30 days, or having had a previous experimental gene or immunotherapy for this type of bladder cancer.
- Radiotherapy to the pelvis or prostate brachytherapy (internal radiation) in the last 12 months.
- History of interstitial lung disease or lung inflammation, if previously treated with a PD-1 or PD-L1 inhibitor (a type of immunotherapy).
- Evidence the cancer has spread to other parts of the body.
- A history of problems having a catheter fitted that would stop EG-70 being given.
- Active interstitial cystitis (long-term bladder inflammation) seen on examination or biopsy.
- An active infection needing treatment.
- Known HIV, hepatitis B or hepatitis C infection.
- Serious heart problems (for example, a stent fitted in the last 8 weeks, or a heart attack in the last 6 months).
- Allergy to any of the other ingredients in the study drug. For the bladder rinse groups, a known allergy to polidocanol.
What taking part involves
- • EG-70 is given directly into the bladder through a catheter (a thin tube).
- • You need to keep the medicine in your bladder for 60 minutes after it is given.
- • The trial has two phases, and which phase you join affects some of the entry rules.
Time commitment: Not stated — ask the trial team, as the registry data does not give the number of visits, how long the study lasts, or how often treatment is given.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 350
- Started
- 2021-04-22
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for superficial bladder cancer
- • Phase1/Phase2 - 350 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with superficial bladder cancer
Where?
- • London - The Royal Marsden NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
EG-70 is a novel non-viral gene therapy. EG-70 is designed to elicit a local immune response following delivery of the study gene therapy to the bladder urothelium. This approach of local administration through bladder instillation has the potential to induce a potent immune response exclusively at the site of the tumor, resulting in greater therapeutic benefit while reducing undesirable systemic toxicity. Eligible BCG-unresponsive NMIBC with CIS patients will be enrolled in Phase 1, and Cohort 1 of Phase 2. Eligible high-risk NMIBC patients will be enrolled in Phase 2 into separate cohorts include: BCG-naïve patients or BCG-exposed (incompletely treated) patients with Carcinoma in situ (CIS), and BCG-unresponsive HG Ta/T1 papillary disease without CIS. Patients will be treated for up to four 12-week cycles of study drug instillation doses and assessments with follow up assessments. Patients with complete response following four treatment cycles will enter up to 8 maintenance treatment cycles.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative pregnancy test at Screening
- ✓ to utilize a condom for the duration of the study treatment through 3 months post-dose
- ✓ satisfactory bladder function with ability to retain study drug for 60 minutes
What the study is looking for
- ✓BCG-unresponsive Patients:
- ✓Phase 2 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...
Who cannot take part
- ✗Active malignancies (i.e., progressing or requiring treatment change in the last 24 months). Exceptions allowed...
- ✗Concurrent treatment with any chemotherapeutic agent.
- ✗History of partial cystectomy.
- ✗Treatment with last therapeutic agent (including intravesical drug treatment post-TURBT) within 30 days of Screening...
- ✗Patients who have received systemic immunosuppressive medication including high-dose corticosteroids.
See the full criteria
Where Is This Study? (1 UK site)
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
How to Get in Touch
enGene clinical trials
Sponsor contactCONTACT
Chris Tosone
Sponsor contactCONTACT
