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
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
Intermediate Risk NMIBC
PIVOT: A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Phase: 3
Study Product: CG0070 (I+M) after TURBT vs observation after TURBT
Estimated Study Completion Date: January 2030
ClinicalTrials.gov Identifier: NCT06111235
MoonRISe-1: A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
Phase: 3
Study Product: erdafitinib intravesical (TAR-210) vs MD choice of intravesical chemo
Estimated Study Completion Date: June 28, 2028
ClinicalTrials.gov Identifier: NCT06319820
Low Grade or IR or High Grade NMIBC BCG Naïve/no BCG within 2 years or post BCG
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: July 2024
ClinicalTrials.gov Identifier: NCT05483868
High grade NMIBC BCG Naïve or no BCG within 3 years
PATAPSCO: A Phase IIIb Open-Label, Single-Arm, Multi-Center, US Study of Bacillus Calmette-Guerin (BCG) Administered in Combination with Durvalumab in Adult BCG-naïve, High-risk Non–Muscle-Invasive Bladder Cancer Participants
Phase: 3
Study Product: Durva + BCG (induction + maintenance), no BCG within 3 years
Estimated Study Completion Date: May 30, 2027
ClinicalTrials.gov Identifier: NCT05943106
High Grade NMIBC BCG Naïve/no BCG within 2 years or post BCG
Protara ADVANCED-2: A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
Phase: 2
Study Product: intravesical TARA-002 for NMIBC with CIS– cohort A: BCG naïve, cohort B: post BCG
Estimated Study Completion Date: August 2030
ClinicalTrials.gov Identifier: NCT05951179
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
Intermediate Risk or High Grade NMIBC post BCG
PROKARIUM: A Phase 1/1b Study Evaluating the Safety, Pharmacology, and Clinical Effect of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
Phase: 1
Study Product: phase 1 ZH9 (microbial IO) oral priming + intravesical, post BCG or BCG intolerable & post 1L intravescial tx
Estimated Study Completion Date: May 30, 2027
ClinicalTrials.gov Identifier: NCT06181266
High Grade NMIBC Post BCG
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
CG BOND: A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Phase: 3
Study Product: cohort P: intravesical cretostimogene for BCG unresponsive NMIBC without CIS
Estimated Study Completion Date: January 2030
ClinicalTrials.gov Identifier: NCT06111235
SeaGen EV-104: A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Phase: 1
Study Product: dose expansion-intravestical EV for BCG-unresponsive NMIBC with CIS
Estimated Study Completion Date: May 31, 2028
ClinicalTrials.gov Identifier: NCT05014139
SunRISe-5: A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator’s Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Phase: 3
Study Product: TAR-200 (GemRIS) vs MD choice of intravesical chemo for recurrent NMIBC without CIS post at least 5 of 6 induction BCG and RC refusal
Estimated Study Completion Date: April 14, 2031
ClinicalTrials.gov Identifier: NCT05014139
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
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
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: cohort 5: intratumoral injection of AU-011 (bel-sar) + laser then RC
Estimated Study Completion Date: July 2024
ClinicalTrials.gov Identifier: NCT05483868
Locally Advanced or Metastatic UC
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
BICYCLE: A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Phase: 2/3
Study Product: Tx Naïve and platinum eligible-cohort 1: Bicycle Toxin Conjugate (BTC) 5 mg/m2 + Pembro vs BTC 6 mg/m2 + Pembro vs Chemo (Gem + Carbo); Post Tx- cohort 2: BTC 5 mg/m2 vs BTC 6 mg/m2
Estimated Study Completion Date: December 2030
ClinicalTrials.gov Identifier: NCT06225596
RCC
Locally Advanced or Metastatic – treatment naïve
Exelixis Stellar-002 expansion:
Phase: 1
Study Product: cohort 6: nccRCC- Arm 1: XL092 vs Arm 2: XL092 + Nivo (must have measurable disease)
Estimated Study Completion Date: May 2026
ClinicalTrials.gov Identifier: NCT05176483
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.
