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 3 years

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


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 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


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: July 2024
ClinicalTrials.gov Identifier: NCT05483868


Intermediate Risk NMIBC

PIVOTA 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


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 BLC3001A 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-905Perioperative 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


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


RCC

Locally Advanced or Metastatic – treatment naïve

Exelixis Stellar-002 expansion

Study Product: cohort 6: nccRCC- Arm 1: XL092 vs Arm 2: XL092 + Nivo (must have measurable disease) 


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.