Bladder Cancer

Low or Intermediate risk NMIBC

Vaxiion– Phase I Safety and Tolerability of Intravesical VAX014 for Instillation in Subjects with Non-Muscle Invasive Bladder Cancer (NMIBC)

Phase: 1
Study Product: Intravesical VAX014 
Estimated Study Completion Date: 
ClinicalTrials.gov Identifier: NCT03854721

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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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Urogen BL006– A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients with Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

Phase: 3
Study Product: UGN-102 with or without TURBT vs TURBT alone
Estimated Study Completion Date: December 2023
ClinicalTrials.gov Identifier: NCT04688931

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Low Grade Upper Tract UC

TOOKAD Steba– 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: TOOKAD VTP
Estimated Study Completion Date: July 4, 2024
ClinicalTrials.gov Identifier: NCT04620239

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High grade NMIBC BCG Naïve or no BCG within 2 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

High Grade NMIBC Post BCG

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

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

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BOND003:A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)

Phase: 3
Study Product: CG0070
Estimated Study Completion Date: December 2024
ClinicalTrials.gov Identifier: NCT04452591

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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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Seattle Genetics EV-103: A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

Phase: 1b/2
Study Product: neoadjuvant therapy followed by Radical Cystectomy for cis-ineligible MIBC – Cohort H: Enfortumab vedotin (EV), Cohort J: EV + Pembrolizumab
Estimated Study Completion Date: March 2026
ClinicalTrials.gov Identifier: NCT03288545

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Istari LUMINOS-103: 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: Cohort A: neoadjuvant PVSRIPO (intratumoral injection) + RC for cisplatin-ineligible/refusal
Estimated Study Completion Date: May 2025
ClinicalTrials.gov Identifier: NCT04690699

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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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Hyperoxaluria

Allena 177-302: Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)

Phase: 3
Study Product: Reloxaliase (oxalate decarboxylase) placebo-controlled for enteric hyperoxaluria
Estimated Study Completion Date: November 2023
ClinicalTrials.gov Identifier: NCT03847090

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