Clinical Trial Search

Primary: Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy — 40.9; 39.1 percentage of patients

Primary: Complete Response Rate at 3 Months — 39 percentage of participants

Primary: Number of Participants With Complete Response at 3 Months — 26 Participants

Primary: Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD) — NA; 360 mg

Primary: Median Overall Survival — 13.9 months

Primary: Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 — 15; 14; 20 Participants

Primary: Complete Response (CR) Rate for UGN-102 Treatment — 65.1 percentage of patients

Primary: Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging…

Primary: Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events — 0; 4; 3; 6 Participants

Primary: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) — 3; 3; 3; 9 Participants

Primary: Bladder Tumor Recurrence Rate — 41.37 percentage of subjects

Primary: Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009 — 0; 0; 0; 0 Participants

Primary: Number of Participants With Adverse Events — 2 Participants

Primary: Phase I - Dose-limiting Toxicity (DLT) — 0 DLT

Primary: Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion — 13 Participants

Primary: Clinical Complete Response (CCR) Rate — 43 Percentage of participants

Primary: Phase Ib: Safety of Pembrolizumab in Combination With Gemcitabine-Cisplatin — 0 Participants

Primary: Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy — 46 percentage of participants

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs of Special Interest. — 8; 3; 2; 7…

Primary: Percentage of Participants Free From Radical Cystectomy at 3 Years — 88.2 percentage of participants

Primary: Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment — 27.3 percentage of patients

Primary: Number of Grades 1-5 Adverse Events — 12; 3; 15; 9 adverse events

Primary: Mean log2 (Fold Change of CD3+ T-Cell Count/µm2) Over Time — -0.036; -0.041; 1.516 log2(fold change)

Primary: Complete Tumor Response Defined as the Absence of New Tumors — 64.1 percentage of participants

Primary: Overall Pathological Response Rate — 57.7 % of participants

Primary: Disease Recurrence Rate — 27.86; 40 percentage of patients with recurrence — p=0.01

Primary: Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of…

Primary: Objective Response Rate (ORR) — 1; 2 Participants

Primary: Objective Response Rate (ORR) — 69.6; 33.3 Percentage of participants

Primary: Percentage of Participants With Progression Free Survival (PFS) at 2 Months — 54 % of participants with PFS