Bladder Cancer

Low or Intermediate risk NMIBC

JH Incyte– Phase 2 Window of Opportunity Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients with Recurrent Low-or Intermediate-Risk Tumors

Phase: 2
Study Product: Pemigatinib
Estimated Study Completion Date: May 2023
ClinicalTrials.gov Identifier: NCT03914794

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Janssen ErdaRIS– Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants with Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or Fusions

Phase: 1
Study Product: Erdafitinib Intravesical Delivery System
Estimated Study Completion Date: April 14, 2027
ClinicalTrials.gov Identifier: NCT05316155

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Low Grade Upper Tract UC

TOOKAD ENLIGHTENED– Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Phase: 3
Study Product: padeliporfin
Estimated Study Completion Date: January 25, 2029
ClinicalTrials.gov Identifier: NCT04620239

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High grade NMIBC BCG Naïve or no BCG within 2-3 years

KEYNOTE-676: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in HR NMIBC

Phase: 3
Study Product: Cohort B: Pembrolizumab + BCG (full M) vs. Pembro + BCG (reduced M) alone
Estimated Study Completion Date: November 25, 2024
ClinicalTrials.gov Identifier: NCT03711032

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KEYNOTE-676: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in HR NMIBC

Phase: 3
Study Product: Cohort A: Pembrolizumab + BCG vs. BCG alone for HR NMIBC that is persistent or recurring following BCG induction
Estimated Study Completion Date: November 25, 2024
ClinicalTrials.gov Identifier: NCT03711032

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Theralase: A study of intravesical photodynamic therapy for BCG-unresponsive NMIBC patients WITH CIS

Phase: 2
Study Product: TLD-1433 Bladder Infusion + Photodynamic Therapy
Estimated Study Completion Date: May 2022
ClinicalTrials.gov Identifier: NCT03945162

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MK057: A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination With Other Investigational Agents in Subjects With High Risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

Phase: 2
Study Product: cohort C: Vibostolimab/Pembro vs Favezelimab/Pembro for persistent or recurrent CIS post BCG 
Estimated Study Completion Date: August 31, 2030
ClinicalTrials.gov Identifier: NCT02625961

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Low Grade or IR or High Grade NMIBC BCG Naïve or no BCG within 2 years

Aura: A Phase 1, open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility and safety of intramural injection with or without intratumoral injection in subjects with non-muscle invasive bladder cancer (NMIBC)

Phase: 1
Study Product: intramural injection w/wo intratumoral injection of AU-011 (belzupacap sarotalocan); cohort 1a: intramural injection then RC, cohort 1b: intramural & intratumoral injection then TURBT, cohort 2: intramural injection + laser then TURBT, cohort 3: intramural injection + laser then RC, cohort 4: intramural & intratumoral injection + laser then TURBT
Estimated Study Completion Date: August 2023
ClinicalTrials.gov Identifier: NCT05483868

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High Grade NMIBC BCG Naïve/no BCG within 2 years or post BCG

Protara TARA-002: A Phase 1a/b, dose finding, open-label study to evaluate safety and toxicity, of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer

Phase: 1
Study Product: dose finding of intravesical TARA-002 for CIS unable to receive BCG or received at least one dose of BCG or intravesical chemo
Estimated Study Completion Date: May 2023
ClinicalTrials.gov Identifier: NCT05085977

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Istari Luminos: A Basket Trial Evaluating the Safety and Efficacy of PVSRIPO and PVSRIPO in Combination with Anti-PD-1/L1 Checkpoint Inhibitors in Patients with Advanced Solid Tumors

Phase: 1/2
Study Product: intravesical PVSRIPO, BCG naïve or post BCG (adequate or not), no BCG within 3 months 
Estimated Study Completion Date: May 2025
ClinicalTrials.gov Identifier: NCT04690699

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enGene: 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: 1/2
Study Product: intravesical EG-70 (non-viral gene therapy) CIS, cohort 1: post BCG, cohort 2: BCG naïve or incomplete BCG
Estimated Study Completion Date: February 2026
ClinicalTrials.gov Identifier: NCT04752722

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SURGEtx: A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer

Phase: 1/2a
Study Product: intramural injection STM-416 after TURBT
Estimated Study Completion Date: September 2024
ClinicalTrials.gov Identifier: NCT05710848

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MIBC

Bladder Sparing

KEYNOTE-992: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)

Phase: 3
Study Product: Pembrolizumab with Chemoradiotherapy (CRT) vs. CRT Alone
Estimated Study Completion Date: February 10, 2027
ClinicalTrials.gov Identifier: NCT04241185

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Janssen BLC3001: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

Phase: 3
Study Product: TAR-200 plus Cetrelimab vs. CRT
Estimated Study Completion Date: December 15, 2028
ClinicalTrials.gov Identifier: NCT04658862

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Radical Cystectomy

KEYNOTE-905: Perioperative Pembrolizumab (MK-3475) Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer

Phase: 3
Study Product: Pembrolizumab with Radical Cystectomy plus Pelvic Lymph Node Dissection vs. Radical Cystectomy plus Pelvic Lymph Node Dissection
Estimated Study Completion Date: February 16, 2026
ClinicalTrials.gov Identifier: NCT03924895

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Asieris YHGT-NP-01: A Phase I/II Open-Label Multicentre Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination with Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients with Muscle Invasive Bladder Cancer (MIBC)

Phase: 1/2
Study Product: neoadjuvant Nitroxoline + Tislelizumab + RC for cisplatin-ineligible/refusal
Estimated Study Completion Date: March 1, 2024
ClinicalTrials.gov Identifier: NCT04813107

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