What is the purpose of
the LEGEND Study?

The LEGEND study will test if a study drug can safely help the body destroy cancer cells to ultimately delay, or ideally, prevent bladder removal for people with non-muscle invasive bladder cancer (NMIBC).

Who can join the LEGEND study?

You may be able to join the LEGEND study if you:

  • are 18 years of age or older
  • have been diagnosed with bladder cancer that has not extended into the muscle (NMIBC) AND
    • are ineligible for or have decided not to undergo cystectomy
      • have carcinoma in situ (CIS) that is unresponsive to, or returned after, a partial or full course of BCG therapy OR
      • have papillary tumors without CIS that is unresponsive to, or returned after, BCG therapy OR
    • have CIS and you have NOT received BCG therapy but have received at least one dose of intravesical chemotherapy (given in the bladder)
  • can retain study drug in the bladder for 60 minutes
  • have normal kidney function
  • are ambulatory or sedentary; able to carry out light work and capable of self-care

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If you meet the requirements listed above, you may qualify to participate in the study. Other study requirements will apply, please contact a study location for additional information.

What will happen during the
LEGEND study?

If you qualify and decide to join the LEGEND study, your active participation may last up to 144 weeks (about 3 years). The study is divided into the following periods:

Screening (about 2-4 weeks)

You will have routine study tests and procedures to find out if you are eligible to participate in the study.

Study Drug Treatment Period (up to 48 weeks)

You will receive at least 1 cycle, and as many as 4 cycles, of the study drug. One cycle is 12 weeks.

You will receive the study drug 4 times per cycle: once a week for the first 2 weeks of each cycle and once each on the fifth and sixth week of each cycle.

You will have a routine cystoscopy and your urine evaluated near the end of each cycle  to assess whether or not you have responded to the study drug and determine the optimal path forward, which may include continuing treatment with an additional dosing cycle.

Maintenance Treatment (up to 48 weeks)

If you continue to respond to study treatment, you will continue to receive up to 4 additional cycles.

You will receive the study drug once a week for the first 2 weeks of each cycle.

You will have a routine cystoscopy and your urine evaluated the end of each cycle to assess whether or not you have responded to the study drug and determine the optimal path forward, which may include continuing treatment with an additional dosing cycle.

If you continue to respond to study treatment, you may continue to receive up to 4 additional cycle (up to 48 weeks) or enter a follow up period where you will not receive additional EG-70 study drug. Your study doctor will review these options with you.

Follow-up (up to 48 weeks)

If the cancer has not come back after you complete treatment and maintenance treatment cycles, you will follow-up study visit every 12 weeks (about 3 months) 48 weeks.

What will happen during the
LEGEND study?

If you qualify and decide to join the LEGEND study, your active participation may last up to 144 weeks (about 3 years). The study is divided into the following periods:

Screening (about 2-4 weeks)
You will have routine study tests and procedures to find out if you are eligible to participate in the study.

Study Drug Treatment Period (up to 48 weeks)
You will receive at least 1 cycle, and as many as 4 cycles, of the study drug. One cycle is 12 weeks.

You will receive the study drug 4 times per cycle: once a week for the first 2 weeks of each cycle and once each on the fifth and sixth week of each cycle.

You will have a routine cystoscopy and your urine evaluated near the end of each cycle to assess whether or not you have responded to the study drug and determine the optimal path forward, which may include continuing treatment with an additional dosing cycle.

Maintenance Treatment (up to 48 weeks)
If you continue to respond to study treatment, you will continue to receive up to 4 additional cycles.

You will receive the study drug once a week for the first 2 weeks of each cycle.

You will have a routine cystoscopy and your urine evaluated the end of each cycle to assess whether or not you have responded to the study drug and determine the optimal path forward, which may include continuing treatment with an additional dosing cycle.

If you continue to respond to study treatment, you may continue to receive up to 4 additional cycle (up to 48 weeks) or enter a follow up period where you will not receive additional EG-70 study drug. Your study doctor will review these options with you.

Follow-up (up to 48 weeks)
If the cancer has not come back after you complete treatment and maintenance treatment cycles, you will follow-up study visit every 12 weeks (about 3 months) 48 weeks.