Bladder Cancer Clinical Trial

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

Summary

To evaluate the activity of intravesical (IVE) administration of CG0070 in patients with tissue pathology confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease

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Full Description

Cohort C(All Countries) :

An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease

BCG failure is defined as a persistent or recurrent disease within 12 months of completion of adequate BCG therapy.

Cohort P(Japan and the United States Only):

To determine the all-cause High Grade Event Free Survival (HG-EFS) of cretostimogene in up to 75 patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS.

BCG failure is defined as a persistent or recurrent disease within 6 months of completion of adequate BCG therapy.

View Eligibility Criteria

Eligibility Criteria

Cohort C Inclusion Criteria

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

Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent.
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) BCG unresponsive CIS. Patients with BCG unresponsive CIS are those unlikely to benefit from, and who will not be receiving, further intravesical BCG. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols (e.g., BCG weekly × 6 then weekly × 3 weeks administered at Months 3, 6, 12, 18, 24, and 36). Specifically, the definition of BCG unresponsive CIS will also require the following:

Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) within 12 months of completion (last dose) of adequate BCG treatment for HGUC (e.g., CIS, HG Ta, HG T1, or a combination of these HGUC pathologies).
Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG (e.g., induction and initial maintenance or re-induction cycle must be completed over no more than a 12-month period of time).
Pathological confirmation of BCG unresponsive CIS within 8 weeks of study enrollment.
CIS specimen must be predominantly urothelial (transitional cell) and have less than 50% variant (e.g., sarcomatoid, squamous etc. component) histology.
No maximum limit to the amount of BCG administered but maintenance BCG should be administered on a schedule consistent with the SWOG 8507 regimen (Lamm 2000).
Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment (e.g., prior to Day 1 treatment).
Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
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

Cohort P Inclusion Criteria

Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent
Have ECOG performance status of 0 to 2.

Have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) BCG-unresponsive HG Ta/T1 papillary disease without CIS. Patients with BCG-unresponsive HG Ta/T1 papillary disease are those unlikely to benefit from and who will not be receiving further IVE BCG. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive HG Ta/T1 papillary disease without CIS will also require the following:

Pathologically confirmed recurrent HG Ta/T1 papillary disease without CIS within 6 months of completion (last dose) of adequate BCG treatment for HGUC (e.g., CIS, HG Ta, HG T1, or a combination of these HGUC pathologies).
Patients with HG Ta: Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG (e.g., induction and initial maintenance or re-induction cycle must be completed over no more than a 12-month period of time).
Patients with HG T1: Patients may be eligible after the initial induction alone (5 of 6 doses of an induction course) as the qualifying BCG treatment.
Completion (last dose) of qualifying BCG treatment within 12 months of study enrollment.
Pathological confirmation of BCG-unresponsive HG Ta/T1 papillary disease without CIS within 8 weeks of study enrollment.
All pathology specimens must be predominantly urothelial (transitional cell) and have less than 50% variant (e.g., sarcomatoid, squamous etc. component) histology.
No maximum limit to the amount of BCG administered; however, there should be no more than 12 months between cycles of BCG
Have all Ta and/or T1 disease resected, prior to study treatment (e.g., prior to Day 1 treatment).
Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy based on Investigator assessment.
Demonstrate adequate organ function,
Patients must be willing to comply with study-mandated cystoscopies, urine cytology, imaging, biopsies, and other procedures for the duration of the trial

Cohort C and Cohort P Key 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.
Any HGUC as T1, HG Ta, or CIS in the upper genitourinary tract or prostatic urethra (including CIS of the urethra) within 24 months prior to enrollment OR any history of T2 or higher stage urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems, ureters).
Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1.
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.
IVE therapy within 8 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g., Mitomycin C, gemcitabine, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted 14 or more days prior to beginning study treatment

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

190

Study ID:

NCT04452591

Recruitment Status:

Recruiting

Sponsor:

CG Oncology, Inc.

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There are 26 Locations for this study

See Locations Near You

Mayo Clinic Cancer Center
Phoenix Arizona, 85054, United States More Info
Clinical Trials Office All Mayo Clinic Locations
Contact
855-776-0015
Mark Tyson, MD
Principal Investigator
Arizona Institute of Urology
Tucson Arizona, 85704, United States More Info
Crystal Palencia
Contact
Jay Page, MD
Principal Investigator
University of California - Irvine
Irvine California, 92868, United States More Info
Steven Bereta
Contact
Edward Uchio, MD
Principal Investigator
University of Colorado
Aurora Colorado, 80045, United States More Info
Janet Kukreja
Contact
MedStar Hospital
Washington District of Columbia, 20010, United States More Info
Lambros Stamatakis
Contact
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States More Info
Andrew Hendrix
Contact
Timothy Lyon, MD
Principal Investigator
Moffit Cancer Center
Tampa Florida, 33612, United States More Info
Rodger Li
Contact
Emory University
Atlanta Georgia, 30322, United States More Info
Misaki Mason
Contact
Shreyas Joshi, MD
Principal Investigator
University of Kansas
Kansas City Kansas, 66160, United States More Info
Eugene Lee, MD
Principal Investigator
Chesapeake Urology
Severna Park Maryland, 21076, United States More Info
Rian Dickstein
Contact
Mayo Clinic
Rochester Minnesota, 55905, United States
Mayo Rochester
Rochester Minnesota, 55905, United States More Info
Paras Shah
Contact
Mercy Medical Center
Saint Louis Missouri, 63109, United States More Info
Gautam Agarwal
Contact
Duke University
Durham North Carolina, 27710, United States More Info
Whitney Franz
Contact
Brant Inman, MD
Principal Investigator
Carolina Urologic
Myrtle Sound North Carolina, 29572, United States More Info
Neal Shore
Contact
University of Toledo
Toledo Ohio, 43614, United States More Info
Stephanie Smiddy
Contact
Firas G Petros, MD
Principal Investigator
University of Pennsylvania, Perelman School of Medicine
Philadelphia Pennsylvania, 19104, United States More Info
Hanna Stambakio
Contact
Thomas Guzzo, MD
Principal Investigator
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Ryan Sutton
Contact
Neal Shore, MD
Principal Investigator
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Pamela Steele
Contact
Sam Chang, MD
Principal Investigator
Urology San Antonio, PA
San Antonio Texas, 78229, United States More Info
Kehkashan Arshad
Contact
Daniel Saltzstein, MD
Principal Investigator
Spokane Urology
Spokane Washington, 99202, United States More Info
Shane Pearce
Contact
Barwon Health, University Hospital Geelong
Geelong , , Australia
Royal Melbourne Hospital
Melbourne , , Australia
Wollongong Private Hospital
Wollongong , , Australia
National Cancer Center Hospital East
Chiba , , Japan
Nagoya University Hospital
Fujita , , Japan
Hirosaki University Hospital
Hashimoto , , Japan
Chugoku Rosai Hospital
Hiroshima , , Japan
Shinshu University Hospital
Ishizuka , , Japan
University of Tsukuba Hospital
Kandori , , Japan
Nara Medical University Hospital
Kashihara , , Japan
The Jikei University Kashiwa Hospital
Kashiwa , , Japan
St. Marianna University Hospital
Kikuchi , , Japan
National Hospital Organization Kyoto Medical Center
Kyoto , , Japan
Kagawa Rosai Hospital
Marugame , , Japan
Keio University Hospital
Matsumoto , , Japan
Okayama University Hospital
Okayama , , Japan
Osaka City University Hospital
Osaka , , Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka , , Japan
Kitsato University Hospital
Sagamihara , , Japan
Saitama City Hospital
Saitama , , Japan
Sapporo Medical University Hospital
Sapporo , , Japan
Shizuoka General Hospital
Shizuoka , , Japan
Keio University Hospital
Tokyo , , Japan
Ehime University Hospital
Toon , , Japan
Toyoma University Hospital
Toyoma , , Japan
Wakayama Medical University Hospital
Wakayama , , Japan
National Hospital Organization Yokohama Medical Center
Yokohama , , Japan
Pusan National University Hospital
Busan , 49241, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Pusan National University Yangsan Hospital
Gyeongsang , 50612, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeongnam , 58128, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
Severance Hospital
Seoul , , Korea, Republic of
The Catholic University of Korea
Seoul , , Korea, Republic of
Keelung Chang Gung Memorial Hospital
Keelung City , , Taiwan
Keelung Chang Gung Memorial Hospital
Keelung , 204, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
National Taiwan University Hospital
Taipei , , Taiwan
Taipei Veterans General Hospital
Taipei , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

190

Study ID:

NCT04452591

Recruitment Status:

Recruiting

Sponsor:


CG Oncology, Inc.

How clear is this clinincal trial information?

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