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CORE-008: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos

A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

  • Condition: High-Risk Non-Muscle-Invasive Bladder Cancer
  • Study ID: NCT06567743
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Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Trinity Bivalacqua, MD, PhD
The American Urological Association's 2026 Annual Meeting, between May 15 – May 18, 2026 in Washington D.C., was host to the Society of Urologic Oncology (SUO) Session. Dr. Trinity Bivalacqua presented The First Results from CORE-008 Cohort CX- Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec with Gemcitabine in Patients with High-Risk BCG-Exposed or BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.
Presented by Shreyas Joshi, MD, MPH
The 2026 SESAUA annual meeting featured a bladder cancer session and presentation by Dr. Shreyas Joshi discussing the first results from CORE-008 cohort A assessing intravesical cretostimogene grenadenorepvec in patients with high risk BCG-naïve non muscle invasive bladder cancer.
Presented by Trinity Bivalacqua, MD, PhD
The European Association of Urology (EAU) 2026 Annual Congress was host to a session on risk stratification for non-muscle invasive bladder cancer (NMIBC). Dr. Trinity Bivalacqua presented translational and early clinical findings from Cohort A of the CORE-008 study evaluating intravesical cretostimogene grenadenorepvec in patients with high-risk, BCG-naïve NMIBC.
Presented by Press Release
  • Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 Disease in BOND-003 Cohort P
  • CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety with optimized administration
  • Robust clinical pipeline that spans multiple late-stage studies across intermediate- and high-risk NMIBC
Presented by Trinity Bivalacqua, MD, PhD
The 2025 Society of Urologic Oncology (SUO) Annual Meeting was host to a bladder cancer late-breaking abstract (LBA) session. Dr. Trinity Bivalacqua presented the first results from CORE-008 Cohort A, a phase II trial of intravesical Cretostimogene Grenadenorepvec in patients with high-risk (HR), BCG-naïve, non-muscle invasive bladder cancer (NMIBC).
Presented by Trinity J. Bivalacqua, MD, PhD
 The 2025 SUO annual meeting featured a urothelial carcinoma trials in progress session and a presentation by Dr. Trinity Bivalacqua discussing CORE-008 Cohort B evaluating intravesical cretostimogene grenadenorepvec in patients with high risk, BCG exposed non muscle invasive bladder cancer.
Presented by Siamak Daneshmand, MD
Siamak Daneshmand, MD, discussed updates to the CORE-008 trial protocol, a phase 2 multi-arm, multi-cohort study to evaluate intravesical cretostimogene grenadenorepvec in patients with high-risk non-muscle invasive bladder cancer. Treatment for high-risk non-muscle invasive bladder cancer includes TURBT followed by intravesical BCG, yet high recurrence rates and the ongoing BCG shortage highlight the need for effective, well-tolerated, and readily available treatment options.
Presented by Colin Dinney, MD
Colin Dinney, MD, discussed updates to the CORE-008 trial. Treatment for patients with high-risk non-muscle invasive bladder cancer consists of TURBT followed by intravesical BCG, yet high recurrence rates and the ongoing BCG shortage highlight the need for effective, well-tolerated, and readily available treatment options.
Presented by Gary D. Steinberg, MD
Gary D. Steinberg, MD, discussed updates to CORE-008, a phase 2 multi-arm, multi-cohort study to evaluate intravesical cretostimogene grenadenorepvec in patients with high-risk non-muscle invasive bladder cancer.
Presented by Trinity Bivalacqua, MD, PhD
The AUA 2025 Annual Meeting was host to a bladder cancer clinical trials in progress session. Dr. Trinity Bivalacqua presented updates to the trial protocol of CORE-008, a phase II multi-arm, multi-cohort trial evaluating intravesical cretostimogene grenadenorepvec in high-risk NMIBC patients.
Presented by Sharada Mokkapati
 The 2025 EAU annual meeting featured a non muscle invasive bladder cancer session and a presentation by Dr. Sharada Mokkapati discussing translational correlates using urinary genomic disease burden to assess cretostimogene grenadenorepvec in the BOND-003 and CORE-001 trials. Urinary genomic disease burden profiling uses next-generation sequencing to identify mutations and DNA alterations associated with bladder cancer. It has shown in prior series to be associated with bladder cancer recurrences and responses to therapy. Cretostimogene grenadenorepvec is an oncolytic immunotherapy with a dual mechanism of action.
Presented by Trinity Bivalacqua, MD
The 2025 GU ASCO annual meeting featured a urothelial carcinoma trials in progress session and a presentation by Dr. Trinity Bivalacqua discussing CORE-008, a phase 2, multi-arm, multi-cohort, open-label study to evaluate intravesical cretostimogene grenadenorepvec in participants with high-risk non-muscle invasive bladder cancer.
Presented by Trinity J. Bivalacqua, MD, PhD
 The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Trinity Bivalacqua discussing CORE-008, a phase 2, multi-arm, multi-cohort, open-label study to evaluate the safety and efficacy of cretostimogene grenadenorepvec in participants with high-risk non-muscle invasive bladder cancer (NMIBC).
Press Releases
Official Announcements on Clinical Developments
Cretostimogene grenadenorepvec is a serotype-5 oncolytic adenovirus designed to selectively replicate in cancer cells with retinoblastoma pathway alterations, previously tested as monotherapy in bacillus Calmette–Guérin (BCG)-experienced non-muscle-invasive bladder cancer.