Bladder Cancer Trials

Open

Name: A Combined Phase 1 and Phase 2 Study of Albumin-bound Rapamycin Nanoparticles in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer
Description: The purpose of this study is to determine appropriate dosing of Albumin-bound Rapamycin and evaluate its safety and anti-tumor activity in the treatment of non-muscle invasive bladder cancer.
Status: Phase 1 is closed for recruitment. Recruitment for Phase 2 to begin soon.
Contact Info: 212-305-6665; ico2106@cumc.columbia.edu (link sends e-mail)
Link: https://clinicaltrials.gov/ct2/show/NCT02009332 (link is external)

 

Name: A Prospective, Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer
Description: The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
Status: Recruitment to begin shortly.
Contact Info: 212-932-4309; gjd16@cumc.columbia.edu (link sends e-mail)
Link: https://clinicaltrials.gov/ct2/show/study/NCT02560584 (link is external)

 

Name: Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the bladder
Description: A combined phase I trial to assess the safety, toxicity, and efficacy of a novel multidrug intravesical regimen consisting of Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG resistant non-muscle invasive urothelial carcinoma of the bladder. This phase I trial will have a combined dose and cycle-escalation scheme with enrollment of up to 24 patients.
Status: Open for recruitment
Contact info: 212-305-5526; ws2375@columbia.edu (link sends e-mail)
Link: https://clinicaltrials.gov/ct2/show/NCT02202772

 

Name: IRB #Q4008 Phase Ib, BISCAY/GU118. Current arm open: durvalumab/olaparib.
Target Population: mUC; Second and later lines.
Inclusion/Exclusion: At least 1 line of a platinum regimen; progressed within 1 year of adjuvant or neoadjuvant chemo; measurable disease by RECIST; required biopsy of lesion not used for RECIST read pre and on study; archived tissue required; no prior immunotherapy allowed.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R5857 Phase I/IIa, Inovio. IM/EP administration of INO agents q3 weeks x4  then q6 weeks x6, then q12 weeks; administered with atezo q3 weeks.
Target Population: mUC (including upper tract).
Inclusion/Exclusion: Cohort A: Progression on or after PD1/PDL1 therapy; Cohort B: No prior therapy for mUC, cisplatin ineligible (eGFR 30-60, hearing loss, or grade 2 neuropathy), measurable disease, pre-treatment bx (A - can be archival, B - new bx); no uncontrolled pain, pl effusion.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R9129 Phase II, Enfortumab. IV days 1, 8, 15 of 28 day cycle.
Target Population: Progression on checkpoint inhibitor.
Inclusion/Exclusion: Platinum naïve or cisplatin inelgible cohort open only; CrCl 30-59; measureable disease required; no uncontrolled diabetes (HbA1C ≥8); no active keratitis or corneal ulcerations.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R7552 Phase II, BMS Neoadjuvant trial (with JHU). Randomized Nivo +/- Urelumab (41BB agonist) 2 doses prior to surgery.
Target Population: MIBC.
Inclusion/Exclusion: T2-4 bladder (urothelial predominant but mixed histologies allowed); cystectomy candidate, cis ineligible (CrCl <60, ecog 2, NYHA III, grade >2 hearing loss or neuropathy).
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R9652 Phase Ib/II, Adapt Bladder. Durvalumab plus BCG vs Durvalumab plus a short course of  EBRT.
Target Population: NMIBC.
Inclusion/Exclusion: BCG unresponsive or relapsing non-muscle invasive bladder cancer.
Status: open for recruitment
Contact Info: 212-305-0114