Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University - LARVOL DELTA

Differential effects of BCG-Russia and BCG-TICE on trained immunity: Potential implications for bladder cancer immunotherapy. (PubMed, PLoS One) - "Therefore, in the present study we compared the effects of BCG-TICE and BCG-Russia on the acquisition of trained immunity and related secondary immune responses...BCG-TICE was linked to upregulation of key inflammation-related genes and enrichment of functionally relevant pathways. The results of this study reveal strain-dependent differences in the ability of BCG to induce innate immune memory and inflammatory pathways that could ultimately determine efficacy of immunotherapy of patients with NMIBC."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SWOG S1602: A phase III randomized trial to evaluate BCG strain differences and priming with intradermal BCG before intravesical therapy for BCG-naïve high-grade non-muscle invasive bladder cancer (NCT #03091660). (ASCO-GU 2026) - "Tokyo-172 is non-inferior to TICE BCG in terms of HG RFS and CIS CR and is similar for PFS. Gr 3-4 AE rate is higher with Tokyo-172. Priming with Tokyo-172 BCG does not improve HG RFS."

Clinical • Late-breaking abstract • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Final Results Of A Phase II Trial Of Bacillus Calmette-Guérin (BCG) And Intravesical Gemcitabine For Patients With BCG-Exposed High-Grade Non-Muscle Invasive Bladder Cancer (NCT04179162) (AUA 2026) - P1/2, P3 | "Patients underwent TURBT followed by intravesical instillation of 2000 mg gemcitabine twice weekly (weeks 1, 4, 7, 10), and once weekly 50 mg TICE BCG (weeks 2, 3, 5, 6, 8, 9) followed by 1-year of maintenance BCG in responders...Four (9%) had prior induction gemcitabine (±docetaxel)... GemBCG in BCG-exposed HG NMIBC demonstrates excellent oncological efficacy with minimal TRAE. Based on these results, the randomized phase III GAIN trial (ALLIANCE A032303/NCT07000084) is comparing GemBCG vs. BCG for patients with BCG-exposed HG-NMIBC and open for enrollment."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Pneumonia • Solid Tumor • Urothelial Cancer

Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST) (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: University of Virginia | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2028 ➔ Dec 2028 | Initiation date: Sep 2025 ➔ Apr 2026 | Trial primary completion date: Dec 2027 ➔ Sep 2028

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: ImmunityBio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Ohio State University Comprehensive Cancer Center

New P4 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Turku University Hospital | Trial primary completion date: Nov 2023 ➔ Nov 2025

Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Turku University Hospital

New P3 trial • Bladder Cancer • Oncology • Solid Tumor

Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Turku University Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Oncology • Solid Tumor

ALBAN: Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients (clinicaltrials.gov) - P3 | N=516 | Recruiting | Sponsor: UNICANCER | Trial primary completion date: Apr 2022 ➔ Apr 2024

Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

ALBAN: Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients (clinicaltrials.gov) - P3 | N=516 | Active, not recruiting | Sponsor: UNICANCER | Trial completion date: Feb 2028 ➔ Oct 2028 | Trial primary completion date: Apr 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

ALBAN: Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients (clinicaltrials.gov) - P3 | N=517 | Active, not recruiting | Sponsor: UNICANCER | Trial primary completion date: Oct 2024 ➔ Jun 2025

Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

ALBAN: Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients (clinicaltrials.gov) - P3 | N=614 | Recruiting | Sponsor: UNICANCER | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Oncology • Solid Tumor • PD-L1

ALBAN: Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients (clinicaltrials.gov) - P3 | N=516 | Active, not recruiting | Sponsor: UNICANCER | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

ALBAN: Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients (clinicaltrials.gov) - P3 | N=614 | Not yet recruiting | Sponsor: UNICANCER

New P3 trial • Bladder Cancer • Oncology • Solid Tumor • PD-L1

QUILT-2.005: A Study Testing a New Drug (ALT-803) With BCG to Treat Early-Stage Bladder Cancer (clinicaltrialsregister.eu) - P1/2 | N=50 | Not yet recruiting | Sponsor: Immunitybio Inc.

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) (clinicaltrials.gov) - P3 | N=1397 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Dec 2025 ➔ Jul 2026

Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

PATIENT-REPORTED OUTCOMES IN THE PHASE II TRIAL OF INTRAVESICAL GEMCITABINE AND BACILLUS CALMETTE-GUERIN (GEMBCG) FOR PATIENTS WITH BCG-EXPOSED HIGH-GRADE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P1/2, P3 | "Patients underwent TURBT followed by intravesical instillation of 2000mg Gemcitabine twice weekly (weeks 1, 4, 7, 10) and once weekly 50mg TICE BCG (weeks 2, 3, 5, 6, 8, 9) followed by 1-year of maintenance BCG in responders. Patient-reported outcomes from our phase II trial of GemBCG in BCG-exposed high-grade NMIBC support the safety of combination chemoimmunotherapy. The increase in urinary toxicity during induction parallels our prior work evaluating PRO-CTCAE toxicity for BCG monotherapy. After 12-months of treatment, there was a decrease in Global QOL, although this was not driven by increased urinary symptoms."

Clinical • P2 data • Patient reported outcomes • Bladder Cancer • Genito-urinary Cancer • Mood Disorders • Oncology • Psychiatry • Solid Tumor

FDA Approval Summary: Nogapendekin Alfa Inbakicept-pmln with BCG for BCG-unresponsive carcinoma in situ. (PubMed, Clin Cancer Res) - "Patients received N-803 400 μg administered intravesically with TICE BCG once a week for 6 weeks as induction therapy, a second induction course if complete response (CR) was not achieved at month 3, and maintenance N-803 with BCG weekly for 3 weeks at months 4, 7, 10, 13, and 19 (for a total of 15 maintenance doses). The most common adverse reactions were increased creatinine, dysuria, hematuria, urinary frequency, urinary urgency, and urinary tract infection. This article summarizes the data and FDA thought process supporting the approval of N-803 with BCG."

FDA event • Journal • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Solid Tumor

Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST) (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: University of Virginia

New P2 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=1000 | Active, not recruiting | Sponsor: SWOG Cancer Research Network | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Expanded Access Program for recombinant BCG launches at first US site (Urology Times) - "U.S. Urology Partners has become the first site to offer recombinant BCG (rBCG) through an Expanded Access Program...for patients with non–muscle invasive bladder cancer (NMIBC) who are eligible to receive intravesical TICE BCG, ImmunityBio announced in a news release....The FDA authorized the EAP last month to provide an alternative source of BCG to patients across the US in an effort to address the ongoing BCG shortage."

Trial status • Bladder Cancer • Urothelial Cancer

EVER: Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients with Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Verity Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2026 ➔ Feb 2029 | Trial primary completion date: Dec 2025 ➔ Feb 2029

Enrollment open • Head-to-Head • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer