Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma in Situ

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antibodies

Antibodies, Monoclonal

Immune Checkpoint Inhibitors

Immunoglobulins

BCG Vaccine

Antineoplastic Agents, Immunological

CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 12, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 12 (e.g., complete response) then the patient will receive 3 weekly treatments.

Beginning at Week 24, patients will receive weekly x 3 treatments every 3 months through Week 48 then every 24 weeks thereafter.

Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 3 weeks for up to 2 years.

CG0070

Immune checkpoint inhibitor, Monoclonal antibody

Pembrolizumab Injection

n-dodecyl-B-D-maltoside

James Burke

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

An opened label trial designed to evaluate CG0070 and DDM in combination with Pembrolizumab in patients with NMIBC who have failed prior BCG therapy.

The target population of 37 subjects with CIS with or without concomitant high-grade Ta or T1 papillary disease will be enrolled.

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

Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.

Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0

Median duration of response in patients with a CR or PR

Median overall survival in months in patients

Median duration of progression free survival of patients

Merck Sharp & Dohme LLC

CG Oncology, Inc.

CG0070 is a conditionally replicating oncolytic adenovirus (serotype 5) designed to preferentially replicate in and kill cancer cells.

CG0070 will be administered at a dose of 1x10\^12 vp intravesically following a sequence of bladder washes with DDM and normal saline.

Jake Silverman

Roger Li, MD

Scott Gilbert, MD

Michael Poch, MD

Wade Sexton, MD

Philippe Spiess, MD

Alice Yu, MD

Logan Zemp, MD

Investigators will evaluate the safety of CG0070 for the treatment of patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).

Study of CG0070 After Transurethral Resection in Patients With IR NMIBC

A Phase 1b, Single Arm Study of CG0070 After Transurethral Resection in Patients With Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Adverse events Grade 3 or higher will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

CR as defined by the response assessment.

RFS is defined as the time from surgical removal of residual lesions after CG0070 treatment to recurrence of low- or high-grade urothelial carcinoma within the bladder.

PFS is defined as the time from documentation of Complete Response (CR) following CG0070 treatment to recurrence of low- or high-grade urothelial carcinoma within the bladder.

CFS is defined as the time from study registration to cystectomy performed for any cause. Reason for cystectomy will be collected and analyzed in conjunction with this endpoint.

H. Lee Moffitt Cancer Center and Research Institute

Infections

Virus Diseases

Single arm intervention with CG0070 to be given at a dose of 1e12 vp weekly for six weeks. Patients who achieve a partial response or a complete response at 6 months post first intravesical intervention will be maintained with the same induction cycle of weekly times six. Patients will be followed every 3 months through Month 24.

Gary Steinberg, MD

To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.

The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC (Non-muscle Invasive Bladder Cancer) patients who failed BCG therapy. Most patients with NMIBCis (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG (Bacillus Calmette-Guerin) intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070, if successful in this trial, will serve to provide a therapeutic alternative for this patient population in need.

Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure

An Open Label, Single Arm, Phase II, Multicenter Study of the Safety and Efficacy of CG0070 Oncolytic Vector Regimen in Patients With Non-Muscle Invasive Bladder Carcinoma Who Have Failed BCG (Bacillus Calmette-Guerin) Therapy and Refused Cystectomy

Defined as the proportion of patients who experience a durable complete response lasting 12 months or longer from the initial confirmed complete response date (first CR assessment to be at least 6 months after the first intravesical intervention) and at least 18 months from the date of the first intravesical intervention

Not available, not collected on study or not currently available

PD-L1 status of cancer cells and immune cells at tumor site by IHC

Patient proportions with no cancer cells in regional lymph nodes at cystectomy

Proportions of patients with a complete response of at least 12 months' duration

PD-1 status of immune cells at tumor site by IHC

Proportions of patients with a partial response and/or a complete response of less than 12 months' duration

Nivolumab

Cisplatin

Both CG0070 (x 6 instillations) and nivolumab (x 2 doses) will be administered at their single-agent dose and schedule.

CG0070 will be administered at a dose of 1x10\^12 vp intravesically following a sequence of bladder washes with 5% DDM and normal saline.

Two neoadjuvant doses of nivolumab 480 mg Q4W (every 4 weeks) for 2 doses (week 2 and 6)

Investigators will evaluate the safety and efficacy of combination neoadjuvant therapy using intravesical CG0070 and IV Nivolumab in cisplatin ineligible patients with Muscle Invasive Bladder Cancer (MIBC).

Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC

A Phase 1 Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With Muscle Invasive Bladder Cancer (MIBC)

The changes in intraepithelial CD8+ T cell density from pre-treatment TURBT to post-treatment cystectomy samples will be assessed using a paired t-test or Wilcoxon signed rank test according to the distribution of changes in the CD8+T cell density. The distribution of changes will be investigated using the Anderson-Darling test.

Adverse events Grade 3 or higher will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

The change in PD-L1 expression on tumor and immune cells from pre-treatment TURBT to post- treatment cystectomy samples will be assessed and analyzed using McNemar test for the change in the percentage of PD-L1 positivity before and after the study treatment, using the Stuart-Maxwell test with 4 ordered categories.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin	NCT04387461	Non Muscle Inva...	CG0070 Pembrolizumab I... n-dodecyl-B-D-m...	18 Years -	CG Oncology, Inc.
Study of CG0070 After Transurethral Resection in Patients With IR NMIBC	NCT06253845	Non-muscle Inva...	CG0070	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure	NCT02365818	Bladder Cancer	CG0070	18 Years -	CG Oncology, Inc.
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin	NCT04387461	Non Muscle Inva...	CG0070 Pembrolizumab I... n-dodecyl-B-D-m...	18 Years -	CG Oncology, Inc.
Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC	NCT04610671	Muscle-Invasive... Bladder Cancer	CG0070 Nivolumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for cg0070

Every month we try and update this database with for cg0070 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cg0070

Every month we try and update this database with for cg0070 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cg0070 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.