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NCT06567743ClinicalTrials.gov

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

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)

RecruitingTaking participants now, according to the registry record.
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In brief

This is 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.

Phase 2325 participants sought80 sites2 countries

Categories

Oncology52%Nephrology & urology39%Obstetrics & gynaecology9%

Registered in 1 registry

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2024-08-23; recorded start 2024-09-16
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (CG Oncology, Inc.)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 65 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 325 participants (target), run at 80 sites, across 2 countries.

How this score is built
  • Enrolment24/40

    325 participants (target)

  • Site count21/25

    65 sites

  • Country count0/15

    Single country

  • Planned duration8/10

    Planned over about 40 months

  • Sponsor scale2/10

    CG Oncology, Inc. has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

This is 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.

In Cohort A, up to 125 participants will be enrolled with pathologically confirmed, high-risk high-grade non-muscle invasive bladder cancer (NMIBC) NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which is naïve to Bacillus Calmette-Guerin (BCG) treatment. Participants with CIS with or without concomitant Ta/T1 NMIBC at baseline will be randomized 1:1 to receive cretostimogene via the current (Arm 1) or an alternative instillation procedure (Arm 2). Participants with papillary-only high-risk NMIBC (i.e., HG Ta/T1 without CIS) at baseline (Arm 3) will receive cretostimogene via the alternative instillation procedure. In Cohort B, up to 150 participants will be enrolled with pathologically confirmed, high-risk high-grade NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to BCG treatment. Participants with CIS-containing pathology at baseline will be recruited into Arm 1 and participants with papillary-only pathology at baseline will be recruited into Arm 2. Both Cohort B Arms 1 and 2 will receive cretostimogene via the alternative instillation procedure. In Cohort CX, up to 50 participants will be enrolled with pathologically confirmed, high-risk high-grade NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to or is unresponsive to BCG treatment. Participants will be randomized 1:1 to receive cretostimogene and gemcitabine either concurrently or sequentially. In all cohorts, study treatment will be administered as a weekly induction course for the first 6 weeks with a reinduction course administered to patients who have CIS and/or high-grade Ta disease at the 3-month evaluation. Following induction, if no high-grade disease is detected, maintenance treatment will begin. This consists of a cycle of three weekly treatments every three months during the first year, and every six months during the second year, with an optional extension to the third year following the same six-month schedule. Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), upper tract assessment and directed resection/biopsy (if indicated) every 3 months for the first 2 years and then every 6 months for a further 2 years or until disease recurrence.

Conditions

  • High-Risk Non-Muscle-Invasive Bladder Cancer

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

Cohort A Key Inclusion Criteria: * Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. * Acceptable baseline organ function. Cohort B Key Inclusion Criteria: * Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. * Acceptable baseline organ function. Cohort CX Inclusion Criteria * Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. * Acceptable baseline organ function. Key Exclusion Criteria (Both Cohorts): * Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer. * High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract. * Significant immunodeficiency. * Pregnant or breastfeeding. * Cohort CX Only: serial intravesical gemcitabine within 24 months

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 2
AllocationRandomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingNONE (0)
Enrolment325 participants sought

Sponsor and collaborators

  • CG Oncology, Inc. Sponsor

Arms and interventions

  • Experimental: Cohort A, Arm 1EXPERIMENTAL

    Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method

  • Experimental: Cohort A, Arm 2EXPERIMENTAL

    Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.

  • Experimental: Cohort A, Arm 3EXPERIMENTAL

    Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.

  • Experimental: Cohort B, Arm 1EXPERIMENTAL

    Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.

  • Experimental: Cohort B, Arm 2EXPERIMENTAL

    Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.

  • Experimental: Cohort CX, Arm 1EXPERIMENTAL

    At all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically

  • Experimental: Cohort CX, Arm 2EXPERIMENTAL

    Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method for two consecutive weeks, followed by gemcitabine administered intravesically in the third week on a cyclic 2:1 visit schedule basis

Interventions

  • Drug Cretostimogene Grenadenorepvec

    Respective Cohort

Outcome measures

  1. Primary outcome

    Cohort A (Arm 1 and 2): Complete response rate

    Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-naïve CIS with or without concomitant high-grade Ta or T1 disease at baseline

    Time frame At 11 and 24 weeks

  2. Primary outcome

    Cohort A (Arm 3): High- Grade Event-Free Survival

    Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-naïve HG Ta/T1 disease without concomitant CIS at baseline.

    Time frame 48 months

  3. Primary outcome

    Cohort B (Arm 1): Complete response rate

    Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-exposed CIS with or without concomitant high-grade Ta or T1 disease at baseline.

    Time frame At 11 and 24 weeks

  4. Primary outcome

    Cohort B (Arm 2): High-Grade Event-Free Survival

    Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed high-grade Ta/T1 papillary disease without CIS at baseline.

    Time frame 48 months

  5. Primary outcome

    Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival

    Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.

    Time frame 48 months

  6. Primary outcome

    Cohort CX (Arms 1 and 2): Safety

    Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.

    Time frame 48 months

  7. Secondary outcome

    Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods

    Evaluate cretostimogene genome and GM-CSF levels, treatment efficacy, and safety by 2 different methods of cretostimogene instillation in participants with pathologically confirmed CIS-containing high-risk NMIBC who are naïve to BCG treatment.

    Time frame At 11 and 24 weeks

  8. Secondary outcome

    Cohort A (Arm 3): High-Grade Event-Free Survival at 12 months

    Determine the proportion of participants with BCG-naive papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months

    Time frame At 12 months

  9. Secondary outcome

    Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response

    Assess duration of response in participants with CIS with or without concomitant HG Ta/T1 disease at baseline

    Time frame 48 months

  10. Secondary outcome

    Cohort B (Arm 2) High-Grade Event-Free Survival at 12 months

    Determine the proportion of participants with BCG-exposed papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months

    Time frame At 12 months

  11. Secondary outcome

    Cohort CX (Arm 1 and 2) Complete response rate

    Determine the complete response rate at any time following treatment with cretostimogene and gemcitabine in participants with BCG-exposed or BCG-unresponsive CIS with or without concomitant high-grade Ta or T1 disease at baseline.

    Time frame At 11 and 24 weeks

Dates

Start dateSeptember 16, 2024 (actual)
Primary completionMarch 31, 2027 (estimated)
CompletionDecember 30, 2027 (estimated)
First postedAugust 23, 2024 (actual)
Last updatedSeptember 3, 2026
Results postedNot stated in the registry record
Status last verifiedSeptember 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

76 sites are recruiting

Canada

FacilityCityState or regionStatus
Centre of Applied Urology Research Nova Scotia Health AuthorityHalifaxNova ScotiaRecruiting

United States

FacilityCityState or regionStatus
Potomac UrologyAlexandriaVirginiaRecruiting
Amarillo Urology ResearchAmarilloTexasCompleted
Anne Arundel UrologyAnnapolisMarylandRecruiting
UPNT Research Institute, LLCArlingtonTexasRecruiting
Emory UniversityAtlantaGeorgiaRecruiting
Urology Austin, PLLC (Urology America)AustinTexasRecruiting
Michael G Oefelein, MD Clinical TrialsBakersfieldCaliforniaRecruiting
Midlantic Urology (Solaris)Bala-CynwydPennsylvaniaRecruiting
Brigham and Women's HospitalBostonMassachusettsRecruiting
Urology of Indiana - CarmelCarmelIndianaRecruiting
University of North CarolinaChapel HillNorth CarolinaRecruiting
Charleston Area Medical CenterCharlestonSouth CarolinaRecruiting
Atrium Health/Levine CenterCharlotteNorth CarolinaRecruiting
Associated Urological SpecialistsChicago RidgeIllinoisRecruiting
The Urology Group (Solaris)CincinnatiOhioRecruiting
University of Cincinnati Cancer CenterCincinnatiOhioRecruiting
Cleveland ClinicClevelandOhioRecruiting
Urology Center of Iowa ResearchCliveIowaRecruiting
Ohio State UniversityColumbusOhioRecruiting
UT Southwestern Medical CenterDallasTexasRecruiting
Urology Clinics of North Texas, PLLCDallasTexasRecruiting
Central Ohio Urology Group (US Urology Partners)GahannaOhioRecruiting
University of FloridaGainesvilleFloridaRecruiting
The Conrad Pearson Clinic (Urology America)GermantownTennesseeRecruiting
Banner MD Anderson Cancer CenterGilbertArizonaRecruiting
UropartnersGlenviewIllinoisRecruiting
Urology of Indiana, LLC (US Urology Partners)GreenwoodIndianaRecruiting
Hackensack University Medical CenterHackensackNew JerseyRecruiting
Chesapeake Urology Research AssociatesHanoverMarylandRecruiting
Penn State University Milton S. Hershey Medical CenterHersheyPennsylvaniaRecruiting
Houston MethodistHoustonTexasRecruiting
City of HopeIrvineCaliforniaRecruiting
Mayo Clinic FloridaJacksonvilleFloridaRecruiting
First Urology, PSCJeffersonvilleIndianaRecruiting
Southern Urology (Urology America)LafayetteLouisianaRecruiting
Colorado UrologyLakewoodColoradoRecruiting
Keystone Urology SpecialistsLancasterPennsylvaniaRecruiting
Advanced Urology Institute (Solaris)LargoFloridaRecruiting
AccellacareLisleIllinoisRecruiting
University of Arkansas for Medical SciencesLittle RockArkansasRecruiting
Arkansas UrologyLittle RockArkansasRecruiting
Urology Associates, Lone TreeLone TreeColoradoRecruiting
Genesis Research (Greater Los Angeles)Los AlamitosCaliforniaRecruiting
Advanced UrologyLos AngelesCaliforniaWithdrawn
Urologic Specialists of Northwest Indiana (Solaris)MerrillvilleIndianaRecruiting
Urology Center of Southern CaliforniaMurrietaCaliforniaRecruiting
Carolina Urologic Research Center, LLCMyrtle BeachSouth CarolinaRecruiting
Urology Associates, PCNashvilleTennesseeRecruiting
Ochsner Medical CenterNew OrleansLouisianaRecruiting

30 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. September 3, 2026

    Site added

    15 sites added (80 total)

    6580

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06567743