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
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
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
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
SunRise-3:A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
Phase: 3
Study Product: TAR-200 (GermRIS) + Cetrelimab vs BCG, no BCG within 3 years
Estimated Study Completion Date: May 9, 2030
ClinicalTrials.gov Identifier: NCT05714202
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 WITH CIS
Phase: 2
Study Product: TLD-1433 Bladder Infusion + Photodynamic Therapy
Estimated Study Completion Date: May 2022
ClinicalTrials.gov Identifier: NCT03945162
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
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
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
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
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
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
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
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
Janssen BLC2002: A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
Phase: 2
Study Product: neoadjuvant TAR-200 (GemRIS) + Cetrelimab + RC vs Cetrelimab + RC for cisplatin-ineligible/refusal
Estimated Study Completion Date: December 17, 2025
ClinicalTrials.gov Identifier: NCT04919512
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 (TAR-210) FGFR+, cohort 4: MIBC scheduled for RC and cisplatin-refusal/ineligible
Estimated Study Completion Date: April 14, 2027
ClinicalTrials.gov Identifier: NCT05316155
Locally Advanced or Metastatic UC
Exelixis Stellar-002 escalation: A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors
Phase: 1b
Study Product: life-prolonging therapies do not exist/are not available or are intolerable- cohort B: XL092 + Nivo + Ipi vs cohort D: XL092 + Nivo/Relatlimab
Estimated Study Completion Date: May 2026
ClinicalTrials.gov Identifier: NCT05176483
LOXO-FG3: An Open-Label, Multicenter Study of LOXO-435 (LY3866288) In Advanced Solid Tumor Malignancies With FGFR3 Alterations
Phase: 1a/b
Study Product: dose-escalation of LOXO-435 (FGFR3 inhibitor) + Pembro for FGFR3+ mUC
Estimated Study Completion Date: June 2025
ClinicalTrials.gov Identifier: NCT05614739
RCC
Locally Advanced or Metastatic – treatment naïve
Exelixis Stellar-002 expansion:
Study Product: cohort 1: ccRCC- Arm 1: XL092 + Nivo , cohort 6: nccRCC- Arm 1: XL092 vs Arm 2: XL092 + Nivo (must have measurable disease)
Locally Advanced or Metastatic – post treatment
Exelixis Stellar-002 escalation:
Study Product: life-prolonging therapies do not exist/are not available or are intolerable for RCC (not ccRCC or nccRCC)- cohort B: XL092 + Nivo + Ipi vs cohort D: XL092 + Nivo/Relatlimab
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.