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Bladder Cancer Trials

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: https://clinicaltrials.gov/ct2/show/NCT02009332

 

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: https://clinicaltrials.gov/ct2/show/study/NCT02560584

 

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: https://clinicaltrials.gov/ct2/show/NCT02202772

 

Prostate Cancer Trials

Name: IRB #R6359 A Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Patients with Unresectable or Metastatic B7-H3-Expressing Neoplasms and Neoplasms whose Vasculature Expresses B7-H3.
Target Population: Progression after at least 1 line of systemic therapy for mCRPC.
Inclusion/Exclusion: mCRPC progressed on at least 1 therapy; RECIST measurable disease; B7H3 positivity not mandatory.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R5156 A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Ascending Doses of AZD4635 Both as Monotherapy and in Combination with Durvalumab in Patients with Advanced Solid Malignancies.
Inclusion/Exclusion: mCRPC with PSA >4; BP 140/90; no prior immunotherapy; measurable disease and paired biopsies required.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R7949 Randomized Phase 1b/2 Study of Nivolumab or Nivolumab Plus BMS-986253 in Combination with Intermittent Androgen Deprivation Therapy in Men with Hormone-Sensitive Prostate Cancer.
Target Population: Biochemical recurrence, not castrate.
Inclusion/Exclusion: Biochemical recurrence, testosterone 200+; may have metastases; PSA 2-50, PSA DT <12 months.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R6032 A Phase II Study for Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers.
Target Population: mCRPC to start next line of therapy.
Inclusion/Exclusion: mCRPC patients who will begin new therapy.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R8201 A Phase 1 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients with Advanced Prostate Cancer Refractory to Androgen Therapy.
Target Population: Post 2 treatments for mCRPC.
Inclusion/Exclusion: PD on prior systemic therapy by PCWG3.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R8172: A Phase 2 Study of Nivolumab in Combination with Either Rucaparib, Docetaxel, or Enzalutamide in Men with Castration-resistant Metastatic Prostate Cancer (CheckMate 9KD: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9KD).
Target Population: mCRPC.
Inclusion/Exclusion: Prostate cancer progression by PCWG3.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R9808: A Phase I Trial of Apalutamide plus Abiraterone acetate, Docetaxel, and Prednisone in Patients with Metastatic Castrate Resistant Prostate Cancer (mCRPC).
Target Population: First line mCRPC.
Inclusion/Exclusion: No prior chemo for advanced PC; no prior radioisotope therapy; BP <150/100; no seizures or risk for sz.
Status: open for recruitment
Contact Info: 212-305-0114

 

Name: IRB #R6275: A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors.
Inclusion/Exclusion: Must be 100 days post PD1/PDL1 therapy; CTLA4 naïve; urothelial: must have received or be ineligible/intolerant of cisplatin; CRPC needs measurable disease and progressed on 1-3 treatments for CRPC
Status: open for recruitment.
Contact Info: 212-305-0114