Muscle-Invasive Bladder CarcinomaPhase 1NCT04610671
Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC
A Phase 1 study testing CG0070 and Nivolumab in people with Muscle-Invasive Bladder Carcinoma and Bladder Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer
- What is being tested?
- CG0070 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 25 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
- Participants must be ineligible for cisplatin-based chemotherapy due to any of the following:
- Creatinine clearance (CrCl) < 60 mL/min (with ECOG Performance Status (PS) 0-1)
- Hearing impaired ≥ Grade 2 by CTCAE criteria
- Neuropathy ≥ Grade 2 by CTCAE criteria
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- Heart failure NYHA ≥ III
- ECOG ≥ 2
- Refusing to undergo cisplatin chemotherapy
- Participants must be medically fit for TURBT and radical cystectomy (RC)
- Age ≥ 18 years
- Ability to understand and willingness to sign IRB-approved informed consent
- Willing to provide tumor tissue, blood, and urine samples for research
- Adequate organ function as measured by the following criteria, obtained ≤ 4 weeks prior to registration:
- Absolute Neutrophil Count (ANC) ≥ 1000/mm3 (stable off growth factor within 4 weeks of first study drug administration)
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 8 g/dL
- Serum Creatinine Clearance ≥ 20 mL/min using the Cockcroft-Gault formula
- ALT and AST ≤ 2.5x ULN
- Total Bilirubin ≤ 1.5x ULN (in the absence of previously diagnosed Gilbert's disease)
Who cannot join
- Women who are pregnant or breastfeeding, since the effects of nivolumab and CG0070 on the fetus or breastfeeding child are unknown. All sexually active females of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood test to rule out pregnancy within 4 weeks prior to registration.
- Participant with local symptoms from bladder cancer, (e.g. gross hematuria, dysuria, etc.) who are deemed to be unable to complete the treatment protocol.
- Participant with active or prior documented autoimmune disease within the past 2 years prior to Screening or other immunosuppressive agent within 14 days of study treatment. NOTE: Participant with well controlled type 1 diabetes mellitus, vitiligo, Graves disease, Hashimoto's disease, eczema, lichen simplex chronicus, or psoriasis not requiring systemic treatment (within the past 2 years prior to Screening) are not excluded
- Participants who have concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma. Participants with history of non-invasive (Ta, T1, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible.
- Participants who have another malignancy that could interfere with the evaluation of safety or efficacy of the study drugs. Participants with a prior malignancy will be allowed without Principle Investigator approval in the following circumstances:
- Not currently active and diagnosed at least 3 years prior to the date of registration.
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- Non-invasive diseases such as low risk cervical cancer or any cancer in situ.
- Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy), and in which no chemotherapy was indicated (e.g. low/intermediate risk prostate cancer, etc.). Participants with other malignancies not meeting these criteria must be discussed prior to registration.
- Participants who have received any prior immune checkpoint inhibitor (i.e. anti-KIR, anti-PD-1, anti- PD-L1, anti-CTLA4 or other).
- Participants who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury or specific anti-cancer treatment ≤ 4 weeks prior to starting study drug, or patients who have had placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury.
- 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).
- Participants who have history of chronic active liver disease or evidence of acute or chronic Hepatitis B Virus (HBV) or Hepatitis C (HCV).
- Participants who have known diagnosis of human immunodeficiency virus (HIV) infection. Testing is not required in absence of clinical suspicion.
- Participants who have known diagnosis of any condition (e.g. post-hematopoietic or solid organ transplant, pneumonitis, inflammatory bowel disease, etc.) that requires chronic immunosuppressive therapy which cannot be stopped for the duration of the clinical trial. Usage of non-steroidal anti-inflammatory medications (NSAIDS) for the treatment of osteoarthritis and uric acid synthesis inhibitors for the treatment of gout are permitted.
- Participants with any serious and/or uncontrolled concurrent medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) or psychiatric illness that could, in the investigator's opinion, cause unacceptable safety risks or potentially interfere with the completion of the treatment according to the protocol.
- Participants who have used any live viral vaccine for prevention of infectious diseases within 4 weeks prior to study drug(s). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- Participants unwilling or unable to comply with the protocol.
- Participants with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Participants who participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial throughout the duration of this study.
- Use of excluded antiviral medication that cannot be suspended at least 14 days prior and for 14 days after the administration of any CG0070 treatment throughout the duration of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With Muscle Invasive Bladder Cancer (MIBC)
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).
- Conditions
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer
- Being tested
- CG0070, Nivolumab
- Keywords
- Bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG0070Drug
CG0070 will be administered at a dose of 1x10^12 vp intravesically following a sequence of bladder washes with 5% DDM and normal saline.
NivolumabDrug
Two neoadjuvant doses of nivolumab 480 mg Q4W (every 4 weeks) for 2 doses (week 2 and 6)
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving CG0070 & Nivolumab | Experimental | Both CG0070 (x 6 instillations) and nivolumab (x 2 doses) will be administered at their single-agent dose and schedule. Receives: Drug: CG0070; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Adverse events Grade 3 or higher will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: Up to 24 months after start of treatment
Secondary outcomes (1)
Change in PD-L1 expression on tumor and immune cells
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.
Measured: Up to 24 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start26 Oct 2020
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CG Oncology, Inc., Richard M. Shulze Family Foundation
- Responsible party
- Sponsor
- Investigators
- Roger Li, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610671
- Sponsor's protocol ID
- MCC-20575
- Status last verified
- Feb 2026
- First submitted
- 26 Oct 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Li R, Villa NY, Yu X, Johnson JO, Borjas G, Dhillon J, Moran-Segura CM, Kim Y, Francis N, Dorman D, Powers JJ, Sexton WJ, Spiess PE, Poch MA, Zemp L, Gilbert SM, Zhang J, Pow-Sang JM, Anderson ARA, Li T, Wang X, Grass GD, Burke JM, Dinney CPN, Rodriguez PC, Jain RK, Mule JJ, Conejo-Garcia JR. Oncolytic immunotherapy with nivolumab in muscle-invasive bladder cancer: a phase 1b trial. Nat Med. 2025 Jan;31(1):176-188. doi: 10.1038/s41591-024-03324-9. Epub 2024 Nov 9.
PubMed 39521884
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With Muscle Invasive Bladder Cancer (MIBC)
- ClinicalTrials.gov ID
- NCT04610671
- Acronym / sponsor ID
- MCC-20575
- Conditions
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer
- Keywords
- Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- CG Oncology, Inc., Richard M. Shulze Family Foundation
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving CG0070 & Nivolumab | Experimental | Drug: CG0070, Drug: NivolumabBoth CG0070 (x 6 instillations) and nivolumab (x 2 doses) will be administered at their single-agent dose and schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.)
- Participants must be ineligible for cisplatin-based chemotherapy due to any of the following:
- Participants must be medically fit for TURBT and radical cystectomy (RC)
- Age ≥ 18 years
Key exclusion criteria (24 listed)
- Women who are pregnant or breastfeeding, since the effects of nivolumab and CG0070 on the fetus or breastfeeding child are unknown. All sexually active females of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood test to rule out pregnancy within 4 weeks prior to registration.
- Participant with local symptoms from bladder cancer, (e.g. gross hematuria, dysuria, etc.) who are deemed to be unable to complete the treatment protocol.
- Participant with active or prior documented autoimmune disease within the past 2 years prior to Screening or other immunosuppressive agent within 14 days of study treatment. NOTE: Participant with well controlled type 1 diabetes mellitus, vitiligo, Graves disease, Hashimoto's disease, eczema, lichen simplex chronicus, or psoriasis not requiring systemic treatment (within the past 2 years prior to Screening) are not excluded
- Participants who have concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma. Participants with history of non-invasive (Ta, T1, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible.
- Participants who have another malignancy that could interfere with the evaluation of safety or efficacy of the study drugs. Participants with a prior malignancy will be allowed without Principle Investigator approval in the following circumstances:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG0070CG0070 will be administered at a dose of 1x10^12 vp intravesically following a sequence of bladder washes with 5% DDM and normal saline. | Drug | Participants Receiving CG0070 & Nivolumab |
| NivolumabTwo neoadjuvant doses of nivolumab 480 mg Q4W (every 4 weeks) for 2 doses (week 2 and 6) | Drug | Participants Receiving CG0070 & Nivolumab |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 24 months after start of treatment
Adverse events Grade 3 or higher will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
1 secondary outcome
Change in PD-L1 expression on tumor and immune cells
Time frame: Up to 24 months after start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: PubMed 39521884Li R, Villa NY, Yu X, Johnson JO, Borjas G, Dhillon J, Moran-Segura CM, Kim Y, Francis N, Dorman D, Powers JJ, Sexton WJ, Spiess PE, Poch MA, Zemp L, Gilbert SM, Zhang J, Pow-Sang JM, Anderson ARA, Li T, Wang X, Grass GD, Burke JM, Dinney CPN, Rodriguez PC, Jain RK, Mule JJ, Conejo-Garcia JR. Oncolytic immunotherapy with nivolumab in muscle-invasive bladder cancer: a phase 1b trial. Nat Med. 2025 Jan;31(1):176-188. doi: 10.1038/s41591-024-03324-9. Epub 2024 Nov 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Li, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG0070 and Nivolumab in people with Muscle-Invasive Bladder Carcinoma and Bladder Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Up to 24 months after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.