Bladder Cancer Research & Trials

A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive NMIBC and High-Risk NMIBC Patients who are BCG Naïve or Received Incomplete BCG Treatment (Phase 2)

Inclusion Criteria:

• BCG-unresponsive NMIBC with (CIS) w/ or w/o resected papillary tumors indicated for, ineligible for, or have elected not to undergo cystectomy:

  • persistent HG Ta, T1, or Tis after receiving iBCG (at least 5/6) or recurrence after 12 mo. of receiving iBCG (at least 5/6) or

  • T1 high grade disease residual at the first evaluation following iBCG (at least 5/6)

• Patients previously treated with investigational or approved checkpoint inhibitor (e.g., pembro) who failed treatment are eligible for inclusion 30 days post-treatment

• Male or non-pregnant, non-lactating female

• ECOG 0, 1 or 2

• Hematologic inclusion w/i 2 wks of tx:

  • a. Absolute neutrophil count >1,500/mm3.

  • b. Hemoglobin >9.0 g/dl.

  • c. Platelet count >100,000/mm3.

• Hepatic inclusion w/i 2 wks of Day 1:

  • Total bilirubin ≤1.5 ULN

  • Creatinine clearance >30 mL/min (measured using Cockcroft-Gault or eGFR)

  • AST and ALT ≤2.5 x ULN for the institution, alkaline phosphatase ≤2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis.

• PT and PTT w/i normal limits at Screening.

• Must be able to retain study drug for 60 min

Exclusion Criteria:

• Any other malignancy diagnosed w/i 1 yr of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix)

• Concurrent tx with any chemotherapeutic agent.

• Treatment with pembro w/i 30 days prior to Screening.

• Treatment with last therapeutic agent w/i 30 days of Screening

• Hx vesicoureteral reflux or indwelling urinary stent.

• Participation in any other research protocol involving administration of an investigational agent within 1 mo prior to Day 1.

• Hx external beam radiation to the pelvis at any time or prostate brachytherapy w/i last 12 mo

• Hx interstitial lung disease and/or pneumonitis in patients who have previously received a PD-1 or PD-L1 inhibitor therapy.

• Evidence of metastatic disease.

• Hx difficult catheterization that would prevent administration of EG-70.

• Hx interstitial cystitis.

• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

• Known HIV, Hep B, or Hep C

• Significant cardiovascular risk (e.g., coronary stenting within 8 wks, myocardial infarction within 6 mo).

Principal Investigator: 

Shreyas Joshi, MD

A Phase 2, Randomized, Multi-Center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination with Chemotherapy (Gemcitabine and Docetaxel) or Immunotherapy (Pembrolizumab) in Subjects with High-Grade Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC).

Inclusion Criteria:

•  Diagnosed with CIS ± Ta/T1 high-grade disease. 

• Unresponsive to ≥ 2 courses of BCG therapy within the last 12 months. 

• All visible papillary tumors must be resected and those with persistent T1 disease on TURBT should undergo an additional re-TURBT.

• Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Subjects with prostate cancer on active surveillance at low risk are permitted.

Exclusion Criteria:

• Current or prior evidence of muscle-invasive or metastatic disease. 

• Current systemic therapy for bladder cancer other than IMP used in randomization arm. 

• Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug within 1 month prior to screening. 

• Current or prior pelvic external beam radiotherapy within 5 years of screening. 

• Prior treatment with nadofaragene firadenovec at any time. 

• Prior systemic therapy for bladder cancer at any time. 

• Immunocompromised. 

• Unexplained elevated liver or renal function tests.

Principal Investigator:

Dr. Vikram Narayan

A Phase 3b, Randomised, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Subjects with Intermediate Risk (IR) Non-Muscle Invasive Bladder Cancer (NMIBC).

Inclusion Criteria:

•  Newly diagnosed or recurrent intermediate risk (IR) NMIBC at screening

• Has undergone complete transurethral resection of bladder tumor (TURBT; with or without peri-operative intravesical chemotherapy) within 60 days prior to randomization, with 1 of the following confirmed by a diagnostic pathology report:

  • Recurrence within 1 year, low-grade Ta

  • Solitary low-grade Ta >3 cm

  • Low-grade Ta, multifocal

  • Solitary high-grade Ta, ≤3 cm

  • Low-grade T1a 

Exclusion Criteria:

• Has current or prior evidence of high-risk NMIBC defined as: HG T1, HG Ta >3 cm (recurrent or multifocal), CIS, variant histology, lymphovascular invasion, and T2

• Current or previous evidence of muscle-invasive or metastatic disease presented at the screening visit

• Low-risk NMIBC defined as: First occurrence of low-grade solitary Ta ≤3 cm; Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence; and or papillary urothelial neoplasm of low malignant potential

Principal Investigator:

Dr. Vikram Narayan

An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

Inclusion Criteria:

• Have pathologically confirmed BCG-unresponsive CIS with or without HG Ta or HG T1 NMIBC. Participants with BCG-unresponsive CIS and concomitant LG Ta or LG T1 are also eligible.

• Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible

• Received prior adequate BCG therapy

Exclusion Criteria:

• Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.

• Has received systemic anticancer therapy within 4 weeks of Day 1

• Has had prior systemic treatment (excluding checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies. 

Principal Investigator:

Dr. Vikram Narayan

Blue Light Cystoscopy with Cysview (BLC with Cysview) Registry

Inclusion Criteria:

• Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy, or undergoing surveillance cystoscopy for carcinoma of the bladder

Exclusion Criteria:

• Porphyria

• Gross hematuria

• Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives

Principal Investigator:

Dr. Vikram Narayan

Predicting Functional Changes and Clinical Outcomes in Newly Diagnosed Older Patients with Localized Bladder Cancer undergoing Radical Cystectomy (The UW-RC-BounceBack study)

Inclusion Criteria

• >60 years old at bladder cancer diagnosis

• AJCC Bladder Cancer.

• Able to read, write, and understand English

• Willing and able to provide informed consent.

• Anticipated radical cystectomy with or without NAC

• Patient plan to receive ongoing care for their bladder cancer at the UWMC or FHCC

Exclusion Criteria:

• Presence of metastatic disease or unwilling to provide consent.

• Metastatic bladder cancer

• Language barrier

• Cognitive impairment

• Low literacy affecting ability to answer survey questions in English

• Enrollment on hospice 

Principal Investigator:

Dr. Viraj Master

A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Inclusion Criteria:

Cohort B

• Within 90 days of randomization have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) high-risk HG BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or HG Ta/T1 papillary-only disease without CIS). 

• Have all Ta and/or T1 disease resected, and all CIS resected or fulgurated, as feasible, within 90 days prior to treatment allocation. 

• Refuse radical cystectomy.

Exclusion Criteria:

• Has a current or history of muscle invasive (T2 or higher stage), locally advanced (T3/T4, any N) or metastatic bladder cancer.

• Any HG, non-muscle-invasive urothelial carcinoma (T1, HG Ta, or CIS) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) or urethra (including CIS of the prostatic urethra) within 24 months prior to randomization or treatment allocation OR history of T2 UC in UT

• Has received intravesical therapy within 90 days prior to randomization or treatment allocation except for cytotoxic agents

Principal Investigator:

Dr. Shreyas Joshi

A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer

Inclusion Criteria:

• Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype

• Currently eligible for intravesical BCG therapy

• Performance status: ECOG performance status of 0, 1, or 2

• BCG-naive disease as defined as either of the following:

  • a. Have not received prior intravesical BCG; or

  • b. Previously received BCG, but stopped receiving more than 3 years before date of randomization

Exclusion Criteria:

• Prior BCG treatment in the last 3 years or known hypersensitivity to BCG or known history of BCG Unresponsive NMIBC

• Concurrent use of other investigational agents

• History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer or any other cancer within the past 5 years

• Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV

• Active systemic infection requiring parenteral antibiotic therapy

• Ongoing chronic systemic steroid therapy required

Principal Investigator:

Dr. Shreyas Joshi