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Virus Therapy
CG0070 + Nivolumab for Bladder Cancer
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.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months after start of treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My bladder cancer is confirmed and falls within specific stages without distant spread.
Select...
My bladder cancer surgery was within the last 3 months, and there's enough tissue for testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months after start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months after start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Change in PD-L1 expression on tumor and immune cells
Other outcome measures
Changes in intraepithelial CD8+ T cell density
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
CG0070
2015
Completed Phase 2
~70
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,471 Total Patients Enrolled
CG Oncology, Inc.Industry Sponsor
6 Previous Clinical Trials
659 Total Patients Enrolled
Richard M. Shulze Family FoundationUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bladder cancer symptoms that may prevent me from completing the treatment.I have been diagnosed with HIV.I have not had any autoimmune diseases except for well-controlled conditions like type 1 diabetes or eczema in the last 2 years.My bladder cancer is confirmed and falls within specific stages without distant spread.Criterion: You are unable to receive cisplatin-based chemotherapy due to reasons such as kidney function, hearing or nerve problems, heart failure, or other medical conditions. You must also be eligible for certain surgical procedures, be at least 18 years old, able to understand and sign consent, willing to provide tissue and blood samples, and have certain levels of organ function.I have a history of chronic liver disease or hepatitis B or C.I am on long-term immune-suppressing drugs that I can't stop for a study.I am not pregnant or breastfeeding and have had a recent pregnancy test if applicable.I have serious heart issues that make surgery too risky for me.I have not received a live vaccine in the last 4 weeks.I am not taking any antiviral medication that can't be stopped for the trial period.I have or had upper urinary tract cancer but show no signs of it after treatment.My bladder cancer surgery was within the last 3 months, and there's enough tissue for testing.I have a history of cancer but it's either not active, was treated over 3 years ago, was non-invasive, or was early stage and treated with the intent to cure without chemotherapy.I have previously received immunotherapy treatments.I haven't had major surgery, significant injury, or specific cancer treatment in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Participants Receiving CG0070 & Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the known risks associated with CG0070?
"Due to the limited data supporting CG0070's safety and efficacy, its risk profile is assessed as a 1 on our team's 3-point scale."
Answered by AI
What is the enrollment quota for this research study?
"Affirmative. Per the data hosted on clinicaltrials.gov, this research project is recruiting patients at present. It was first advertised on October 26th 2020 and most recently updated November 11th 2022 with a goal of enrolling 30 individuals from one medical site."
Answered by AI
Is enlistment still open for this trial?
"Data from clinicaltrials.gov reveals that recruitment for this trial is ongoing, commencing on October 26th 2020 and last updated November 11th 2022."
Answered by AI
Has CG0070 been used in prior research studies?
"Presently, there are 719 active clinical trials examining CG0070; 83 of which are in the latter stage. The majority of studies for this treatment occur in Zürich, BE but it is also being studied at 40374 various sites globally."
Answered by AI
What conditions or ailments is CG0070 typically prescribed to treat?
"CG0070 is a reliable treatment for malignant neoplasms, and can also be prescribed to fight unresectable melanoma, squamous cell carcinoma, metastatic esophageal adenocarcinoma."
Answered by AI
Is this experiment a pioneering endeavor?
"Since 2012, CG0070 has been the subject of numerous clinical studies. The first study, sponsored by Ono Pharmaceutical Co. Ltd., was conducted in 2012 and involved 659 patients. After obtaining Phase 1 & 2 drug approval, there are now 719 active trials encompassing 2361 cities across 49 nations."
Answered by AI
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