Bladder Cancer

 

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

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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

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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

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Luminos: A Basket Trial Evaluating the Safety and Efficacy of Lerapolturev (PVSRIPO) and Lerapolturev in Combination With Anti-PD-1/​L1 Checkpoint Inhibitors in Patients With Advanced Solid TumorsPhase: 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

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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

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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

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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

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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

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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

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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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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

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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

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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

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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

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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) 

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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.