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


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


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


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


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


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


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


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


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


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


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


Disclaimer: We update this information regularly. However, what you read today may not be completely up to date. Please remember to talk to your healthcare providers first before making decisions about your plan of care.

Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study. To learn more about our trials, call Jennifer at (843) 449-1010 ext. 316 or email us by filling out the form below.