Where you'll go
2200 Santa Monica Boulevard, Santa Monica, CA, USA 90404
188 West Northern Lights Boulevard, Anchorage, AK, USA 99503
1 Baylor Plaza, Houston, TX, USA 77030
823 82nd Parkway, Myrtle Beach, SC, USA 29572
9500 Euclid Ave, Cleveland, OH, USA 44195
Durham, NC, USA 27708
New York, NY, USA 10032-3784
340 West 10th Street, Indianapolis, IN, USA 46202
Baltimore, MD, USA 21218
11234 Anderson Street, Loma Linda, CA, USA 92354
2160 South 1st Avenue, Maywood, IL, USA 60153
4500 San Pablo Road South, Jacksonville, FL, USA 32224
Rochester, MN, USA 55905
5777 East Mayo Boulevard, Phoenix, AZ, USA 85054
Houston, TX, USA 77006
1275 York Avenue, New York, NY, USA 10065
West Bloomfield, MI, USA 48322
Bronx, NY, USA 10467
500 University Drive, Hershey, PA, USA 17033
Haifa, ISR 3109601
Seattle, WA, USA 98109--1023
Ramat Gan, ISR 52621
410 West 10th Avenue, Columbus, OH, USA 43210
132 South 10th Street, Philadelphia, PA, USA 19107
Los Angeles, CA, USA 90095
1 Shields Ave, Davis, CA, USA 95616
Iowa City, IA, USA 52242
1320 South Dixie Highway, Coral Gables, FL, USA 33146
1500 East Medical Center Drive, Ann Arbor, MI, USA 48109
Minneapolis, MN, USA 55455
Chapel Hill, NC, USA 27514
203 Lothrop Street, Pittsburgh, PA, USA 15213
Norfolk, VA, USA 23507
407 East 61st Street, New York, NY, USA 10065
3085 Harlem Road, Cheektowaga, NY, USA 14225
Details for the study
Treatments and/or Procedures
- Patient is at least 18 years of age.
- Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.
- Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15mm.
- Biopsy taken from one or more tumors located above the ureteropelvic junction (UPJ) showing LG urothelial carcinoma. Diagnosed not more than 2 months prior to the screening.
- Patient should have at least one remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm.
- Wash urine cytology sampled from the pyelocalyceal system documenting the absence of HG urothelial cancer, diagnosed not more than 2 months prior to the screening.
- Patient with bilateral LG UTUC may be enrolled if at least one side meets the inclusion criteria for the trial and if the other kidney does not require further treatments (The other kidney can be treated prior to the beginning of the study).
- Patient received BCG treatment for UC during the 6 months prior to Visit 1.
- The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening)
- Carcinoma in situ (CIS) in the past in the urinary tract.
- Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
- Patient has a history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
- Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.