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Recruiting NCT07283835

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

Phase II Interventional Non Muscle Invasive Bladder Cancer High-grade Ta/ T1 Papillary Disease Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside.
Who it may be relevant to
Registry conditions: Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer

Overview

This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.

Detailed description

An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.

Interventions

  • Biological Cretostimogene Grenadenorepvec
    Engineered Oncolytic Adenovirus
  • Other n-dodecyl-B-D-maltoside
    Transduction-enhancing agent

Primary outcome measures

  • Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS [Time frame: 36 months]
Secondary outcome measures (6)
  • Duration of response (DOR) [Time frame: 36 months]
  • Assess high-grade reoccurrence free survival (RFS) [Time frame: 36 months]
  • Assess progression free survival (PFS) [Time frame: 36 months]
  • Complete response rate at 12, 24, and 36 months [Time frame: Assessed at 12, 24, and 36 months]
  • Overall survival rate at 36 months [Time frame: 36 months]
  • Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE) [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

In order to be eligible for participation in this trial, the patient must:

  • Be ≥18 years of age on day of signing informed consent.

\- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease.

  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
  • Demonstrate adequate organ function.
  • Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.
  • Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.

Exclusion criteria

  • Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
  • History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.
  • Has received systemic anti-cancer therapy, including investigational agents.
  • Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
  • Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.
  • Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 14 centers
  • Peking University First Hospital (First Clinical Medical School of Peking University) — Beijing
  • Chongqing University Cancer Hospital — Chongqing
  • Fujian Cancer Hospital — Fuzhou
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • Hunan Cancer Hospital — Changsha
  • The Affiliated Drum Tower Hospital of Nanjing University Medical School — Nanjing
  • The First Hospital of China Medical University — Shenyang
  • Qilu Hospital of Shandong University — Jinan
  • … and 6 more centers

Identifiers

NCT: NCT07283835 · CG0070-II-CIS-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗