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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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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b8011006: A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

Phase: 3
Study Product: Cohort B: PF-06801591 and include participants who have BCG unresponsive CIS (B1) BCG unresponsive papillary only disease (B2).
Estimated Study Completion Date: July 1, 2028
ClinicalTrials.gov Identifier: NCT04165317

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High Grade NMIBC or MIBC

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 (TAR-201) for NMIBC or MIBC and FGFR+, cohort 1: NMIBC post BCG refusal/ineligible for RC without CIS; cohort 2: NMIBC post BCG scheduled for RC without CIS; cohort 3: recurrent intermediate risk NMIBC with hx of low grade disease; cohort 4: MIBC scheduled for RC and cisplatin-refusal/ineligible 
Estimated Study Completion Date: April 14, 2027 
ClinicalTrials.gov Identifier: NCT05316155

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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: Cohort L: neoadjuvant/adjuvant EV + RC for cisplatin-ineligible MIBC
Estimated Study Completion Date: March 2026
ClinicalTrials.gov Identifier: NCT03288545

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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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