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Virus Therapy

CG0070 + Nivolumab for Bladder Cancer

Tampa, FL
Phase 1
Waitlist Available
Led By Roger Li, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologically confirmed MIBC (T2-T4a, N0-N1, M0 per American Joint Commission on Cancer [AJCC]) pure or mixed histology urothelial carcinoma. Clinical node- positive (N1) patients are eligible provided the lymph nodes (LNs) are within the planned surgical LN dissection template.
The initial TURBT that showed muscularis propria invasion should be within 90 days prior to beginning study therapy. Participants must have sufficient baseline tumor tissue from either initial or repeat TURBTs. The local site pathologist will be asked to estimate and record the rough approximate percentage of viable tumor in the TURBT sample (initial or repeat TURBT with highest tumor content) to document at least 20% viable tumor content prior to registration. This is to ensure adequate tissue is available to perform tumor infiltrating CD8+ T-cell assessment. (The actual CD8+ T cell analysis will be done by a Central Laboratory and will not be done prior to registration.)
Must not have
Participants who have known diagnosis of human immunodeficiency virus (HIV) infection. Testing is not required in absence of clinical suspicion.
Participants who have clinically significant cardiac diseases deemed not fit for radical cystectomy, including any of the following: History or presence of serious uncontrolled ventricular arrhythmias, Clinically significant resting bradycardia, Any of the following within 3 months prior to starting study drug: severe/unstable angina, Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Uncontrolled hypertension defined by a SBP ≥ 180 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti-hypertensive medication(s).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months after start of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new combination therapy for patients with bladder cancer who are not eligible for cisplatin treatment.

Who is the study for?
This trial is for adults with Muscle Invasive Bladder Cancer (MIBC) who can't have cisplatin chemotherapy due to poor kidney function, hearing loss, neuropathy, heart failure or personal choice. They must be fit for certain bladder surgeries and willing to provide tissue samples. Pregnant women, those with serious medical conditions or allergies to the drugs, prior immune therapy use or other active cancers are excluded.
What is being tested?
The study tests a combination of CG0070 (a drug put directly into the bladder) and Nivolumab (an IV drug), in patients not eligible for standard chemotherapy. It aims to assess how safe this combo is and how well it works before removing the bladder.
What are the potential side effects?
Possible side effects include typical reactions related to immune therapies such as fatigue, skin issues, inflammation of organs like lungs or intestines; also potential local effects from CG0070 in the bladder like discomfort or urinary symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bladder cancer is confirmed and falls within specific stages without distant spread.
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My bladder cancer surgery was within the last 3 months, and there's enough tissue for testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with HIV.
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I have serious heart issues that make surgery too risky for me.
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I have a history of chronic liver disease or hepatitis B or C.
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I have not received a live vaccine in the last 4 weeks.
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I am not taking any antiviral medication that can't be stopped for the trial period.
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I have previously received immunotherapy treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months after start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months after start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Change in PD-L1 expression on tumor and immune cells
Other study objectives
Changes in intraepithelial CD8+ T cell density

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
70%
Fatigue
50%
Headache
45%
Confusional state
45%
Cough
40%
Malignant neoplasm progression
35%
Hemiparesis
35%
Diarrhoea
30%
Gait disturbance
30%
Nausea
30%
Pruritus
25%
Urinary tract infection
25%
Fall
25%
Hyperglycaemia
25%
Muscular weakness
25%
Rash
20%
Constipation
20%
Vomiting
20%
Lethargy
20%
Memory impairment
20%
Urinary incontinence
20%
Dizziness
20%
Nasal congestion
15%
Abdominal pain
15%
Alanine aminotransferase increased
15%
Lymphocyte count decreased
15%
Platelet count decreased
15%
Decreased appetite
15%
Arthralgia
15%
Cognitive disorder
10%
Oedema peripheral
10%
Facial paresis
10%
Pyrexia
10%
Candida infection
10%
Depressed level of consciousness
10%
Syncope
10%
Pulmonary embolism
10%
Anaemia
10%
Sinus tachycardia
10%
Anal incontinence
10%
Asthenia
10%
Tooth infection
10%
Upper respiratory tract infection
10%
Aspartate aminotransferase increased
10%
Lipase increased
10%
Paraesthesia
10%
Psychomotor skills impaired
10%
Seizure
10%
Agitation
10%
Anxiety
10%
Disorientation
10%
Dehydration
10%
Hypoalbuminaemia
10%
Hypokalaemia
10%
Hyponatraemia
10%
Aphasia
10%
Dysarthria
10%
Dyspnoea
10%
Rash maculo-papular
5%
Oedema
5%
Pain
5%
Cardio-respiratory arrest
5%
Autoimmune thyroiditis
5%
Dysphagia
5%
Pneumonia
5%
Hip fracture
5%
White blood cell count decreased
5%
Enterocolitis infectious
5%
Tumour flare
5%
Brain oedema
5%
Cerebrovascular accident
5%
Ischaemic stroke
5%
Mental status changes
5%
Aspiration
5%
Herpes zoster
5%
Haemorrhage intracranial
5%
Hypoxia
5%
Pneumonitis
5%
Respiratory distress
5%
Atrial fibrillation
5%
Cushingoid
5%
Hyperthyroidism
5%
Hypothyroidism
5%
Dry eye
5%
Eyelid ptosis
5%
Visual field defect
5%
Visual impairment
5%
Dyspepsia
5%
Oral candidiasis
5%
Stomatitis
5%
Chills
5%
Amylase increased
5%
Blood alkaline phosphatase increased
5%
Blood bilirubin increased
5%
Weight decreased
5%
Weight increased
5%
Tremor
5%
Vasogenic cerebral oedema
5%
Depression
5%
Insomnia
5%
Pollakiuria
5%
Hypocalcaemia
5%
Proteinuria
5%
Back pain
5%
Myalgia
5%
Amnesia
5%
Ataxia
5%
Balance disorder
5%
Dysphonia
5%
Dermatitis acneiform
5%
Dry skin
5%
Deep vein thrombosis
5%
Hypertension
5%
Hypotension
5%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1b: Arm N3+I1
Cohort 1: Arm N3
Cohort 1: Arm N1+I3
Cohort 2: Arm N3
Part A Cohort 1c: Arm N3+RT+TMZ
Cohort 2: Arm B
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Part A Cohort 1d: Arm N3+RT

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants Receiving CG0070 & NivolumabExperimental Treatment2 Interventions
Both CG0070 (x 6 instillations) and nivolumab (x 2 doses) will be administered at their single-agent dose and schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~3880
CG0070
2020
Completed Phase 2
~110

Find a Location

Closest Location:Moffitt Cancer Center· Tampa, FL· 825 miles

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
575 Previous Clinical Trials
145,004 Total Patients Enrolled
CG Oncology, Inc.Industry Sponsor
8 Previous Clinical Trials
727 Total Patients Enrolled
Richard M. Shulze Family FoundationUNKNOWN
Roger Li, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

CG0070 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04610671 — Phase 1
Bladder Cancer Research Study Groups: Participants Receiving CG0070 & Nivolumab
Bladder Cancer Clinical Trial 2023: CG0070 Highlights & Side Effects. Trial Name: NCT04610671 — Phase 1
CG0070 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04610671 — Phase 1
~4 spots leftby Mar 2026
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