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

PHASE3RECRUITING

This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment.

Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately.

Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-10-27

Primary completion: 2027-12-24

Study completion finish: 2029-12-24

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04452591

Intervention or treatment

BIOLOGICAL: Cretostimogene Grenadenorepvec

OTHER: n-dodecyl-B-D-maltoside

Conditions

• Non Muscle Invasive Bladder Cancer
• High-grade Ta/ T1 Papillary Disease Bladder Cancer

Image related to Non Muscle Invasive Bladder Cancer

Condition: Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
BIOLOGICAL: Cretostimogene Grenadenorepvec and other drugs
Geelong, Not Specified, Australia and more
Sponsor: CG Oncology, Inc.

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Find a site

Closest Location:

Barwon Health, University Hospital Geelong

Research sites nearby

Select from list below to view details:

Barwon Health, University Hospital Geelong
Geelong, Not Specified, Australia
Royal Melbourne Hospital
Melbourne, Not Specified, Australia
Wollongong Private Hospital
Wollongong, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort C(All Countries):Enrollment Closed Patients with CIS with or without HG Ta/T1 papillary disease. Cretostimogene will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. Cretostimogene will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has disease recurrence at Week 13, they will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 then the patient will receive 3 weekly treatments. Cohort C(All Countries):Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months and then a last treatment at Weeks 73, 74, and 75 until the tumor returns or study treatment is completed at Week 97. Cohort C Extension( Japan and the US) At Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months starting at Weeks 73, 74, and 75 through Weeks 157, 158, and 159 until the tumor returns or study treatment is completed at Week 159.	BIOLOGICAL: Cretostimogene Grenadenorepvec Engineered Oncolytic Adenovirus
EXPERIMENTAL: Cohort P(Japan and United States Only) :Open to Enrollment HG Ta/T1 papillary disease bladder cancer patients. In Cohort P, cretostimogene will be administered at a dose of 1 × 1012vp IVE following instillation of 5% DDM. Cretostimogene will be administered every week for 6 treatments on Weeks 1, 2, 3, 4, 5, and 6. If the patient has recurrence at Week 13 or any timepoint, the patient will receive a second induction of 6 weekly treatments (Weeks 13, 14, 15, 16, 17, and 18.). If the tumor has not returned they will receive 3 weekly treatments every 12 weeks (approximately 3 months) starting Weeks 13, 14, and 15 through Week 51 (approximately 12 months), and then every 6 months starting at Weeks 73, 74, and 75 (approximately 18 months) through Month 36.	BIOLOGICAL: Cretostimogene Grenadenorepvec Engineered Oncolytic Adenovirus

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Cohort C(All Countries):Enrollment Closed

Patients with CIS with or without HG Ta/T1 papillary disease. Cretostimogene will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. Cretostimogene will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has disease recurrence at Week 13, they will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 then the patient will receive 3 weekly treatments. Cohort C(All Countries):Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months and then a last treatment at Weeks 73, 74, and 75 until the tumor returns or study treatment is completed at Week 97. Cohort C Extension( Japan and the US) At Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months starting at Weeks 73, 74, and 75 through Weeks 157, 158, and 159 until the tumor returns or study treatment is completed at Week 159.

BIOLOGICAL: Cretostimogene Grenadenorepvec

Engineered Oncolytic Adenovirus

EXPERIMENTAL: Cohort P(Japan and United States Only) :Open to Enrollment

HG Ta/T1 papillary disease bladder cancer patients.
In Cohort P, cretostimogene will be administered at a dose of 1 × 1012vp IVE following instillation of 5% DDM. Cretostimogene will be administered every week for 6 treatments on Weeks 1, 2, 3, 4, 5, and 6. If the patient has recurrence at Week 13 or any timepoint, the patient will receive a second induction of 6 weekly treatments (Weeks 13, 14, 15, 16, 17, and 18.). If the tumor has not returned they will receive 3 weekly treatments every 12 weeks (approximately 3 months) starting Weeks 13, 14, and 15 through Week 51 (approximately 12 months), and then every 6 months starting at Weeks 73, 74, and 75 (approximately 18 months) through Month 36.

BIOLOGICAL: Cretostimogene Grenadenorepvec

Engineered Oncolytic Adenovirus

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Cohort C:	To determine the Complete Response rate at any time in patients with BCG-unresponsive CIS with or without concomitant HG Ta/T1 papillary disease.	36 months
Cohort P:	To determine the high-grade EFS of cretostimogene in patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS.Ta/T1 papillary disease without CIS.	36 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Cohort C: Duration of response (DOR)	Median duration of response in patients with a CR or PR in subjects	36 months
Cohort C and Cohort P: Assess high-grade reoccurrence free survival (RFS)	Not Specified	up to 60 months
Cohort C and Cohort P: Assess progression free survival (PFS )	Not Specified	up to 60 months
Cohort C:Complete Response rate at 12 months	Not Specified	12 months
Cohort C and Cohort P : Cystectomy free survival	Not Specified	up to 60 months
Cohort C and Cohort P: Evaluate the safety of Cretostimogene	Not Specified	36 months
Cohort C: Assess overall survival	Not Specified	up to 60 months
Cohort C: Reoccurrence free survival	Not Specified	up to 60 months

Frequently Asked Questions

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References

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

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

Study details:

Eligibility criteria

Inclusion criteria

Eligibility

Things to know

Study dates

Study type

Phase

Trial ID

Intervention or treatment

Conditions

Find a site

Research sites nearby

Study Plan

How is the study designed?

What is the study measuring?

Primary outcome

Secondary outcome

Frequently Asked Questions

References

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