Bladder CancerPhase 2NCT03520491
A Study to Test the Safety of Immunotherapy With Nivolumab Alone or With Ipilimumab Before Surgery for Bladder Cancer Patients Who Are Not Suitable for Chemotherapy
A Phase 2 study testing Nivolumab, Ipilimumab and Radical cystectomy in people with Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to test if immunotherapy with nivolumab alone or in combination with ipilimumab is safe and does not delay the planned bladder cancer surgery. The investigators want to see if treatment with these drugs prior to surgery may decrease the size of the bladder cancer and thus could help make… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Nivolumab, Ipilimumab and Radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Apr 2018to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed diagnosis of urothelial carcinoma of the bladder. Variant histology is acceptable if there is a predominant urothelial component.
- For MUSCLE-INVASIVE UROTHELIAL CANCER OF THE BLADDER (Cohorts 1 - 3):
- ° Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease. Patients with cT4a disease invading into the prostatic stroma with no cystoscopic confirmation of muscle invasion are eligible.
- For UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT (URETER OR RENAL PELVIS) (Cohort U):
- °Histologically confirmed high grade urothelial carcinoma of the upper tract and/or radiographically visible tumor stage T2-T4a N0/x M0 disease with positive selective urinary cytology. Hydronephrosis associated with tumor on imaging or biopsy will be considered invasive by definition. (Variant histology is acceptable if there is a predominant urothelial component)
- Patients ineligible for cisplatin based on any of the following criteria:
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- Estimated or calculated creatinine clearance ≥ 30ml/min but < 60 ml/min
- Grade 2 or above audiometric hearing loss (per CTCAE v4.0)
- Grade 2 or above peripheral neuropathy (per CTCAE v4.0)
- Availability of tumor specimen block or 30 unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than 30 slides available may be enrolled after discussion with the Principal Investigator.
- Karnofsky performance status ≥ 70%.
- Medically appropriate candidate for radical cystectomy, as per MSK Attending Urologic Oncologist
- Age ≥ 18 years.
- Required initial laboratory values:
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Bilirubin ≤1.5 times the upper limit of normal (x ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
- PTT/PT ≤1.5 x ULN or INR < 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.
Who cannot join
- Prior treatment with systemic chemotherapy for urothelial cancer, including immune checkpoint inhibitors for non-muscle invasive bladder cancer. (Prior intravesical treatment such as BCG is allowed.)
- Prior bladder-directed radiotherapy (exclusion applies only to MIBC Cohorts 1 - 3).
- Presence of active autoimmune disease, symptoms, or conditions, with the following exceptions:
- °Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, asymptomatic laboratory evidence of autoimmune disease (e.g.: +ANA, +RF, anti-thyroglobulin antibodies), or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug. Inhaled or topical steroids, and adrenal replacement steroid doses are permitted in the absence of active autoimmune disease.
- Unstable angina.
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- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction within 6 months.
- History of stroke within 6 months.
- Evidence of bleeding diathesis or coagulopathy. Therapeutic anticoagulation is permitted, but patients must be on a stable dose.
- Major surgical procedure within 28 days prior to the study. (Transurethral resection of bladder tumor is permitted
- Serious, non-healing wound, ulcer, or bone fracture.
- Other prior malignancy active within the previous 2 years except for local or organ-confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.
- Subjects who have received prior therapy with any T cell co-stimulation or checkpoint pathways such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137; or other medicines specifically targeting T cells are prohibited. Prior IL-2 is permitted.
- Prior therapy with intravesical BCG within 6 weeks of treatment.
- Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- History of allergy to study drug component or history of severe hypersensitivity reaction to any monoclonal antibody.
- Women who are breastfeeding or pregnant as evidenced by a positive pregnancy test within 14 days of first dose.
- Male subjects who are unwilling to use contraception during the treatment and for at least 31 weeks after the last dose of study treatment (5 half-lives of study drug plus 90 days duration of sperm turnover).
- Women of childbearing potential (WOCBP) not using a medically acceptable means of contraception throughout the study treatment and for at least 23 weeks following the last dose of study treatment (5 half-lives of study drug plus 30 days duration of ovulatory cycle).
- WOCBP are defined as those who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post-menopausal is defined as:
- Amenorrhea ≥ 12 consecutive months without another cause, or
- For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
- Inability to comply with study and/or follow-up procedures.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553
About this study
Official title: A Pilot Study to Evaluate the Safety of Neoadjuvant Nivolumab Alone or in Combination With Ipilimumab for Cisplatin-Ineligible Patients With Muscle Invasive Bladder Cancer (CA209-9DJ)
The purpose of this study is to test if immunotherapy with nivolumab alone or in combination with ipilimumab is safe and does not delay the planned bladder cancer surgery. The investigators want to see if treatment with these drugs prior to surgery may decrease the size of the bladder cancer and thus could help make the surgery more successful.
- Conditions
- Bladder Cancer
- Being tested
- Nivolumab, Ipilimumab, Radical cystectomy
- Keywords
- Immunotherapy, Nivolumab, Ipilimumab, 18-042
- 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.
NivolumabDrug
Nivolumab 3 mg/kg or Nivolumab 1 mg/kg
IpilimumabDrug
Ipilimumab 3 mg/kg
Radical cystectomyProcedure or surgery
RC-PLND is to take place within 60 days from the last dose of treatment.(After week 10 for cohort 1, after week 11 for cohort 2, and after week 9 for cohort 3.)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Nivolumab 3 mg/kg on day 1 of each cycle for a total of 5 cycles. Each cycle will be two weeks long and treatment will occur during weeks 0, 2, 4, 6, and 8. Receives: Drug: Nivolumab; Procedure: Radical cystectomy |
| Cohort 2 | Experimental | Ipilimumab 3 mg/kg and Nivolumab 1 mg/kg on day 1 of each cycle, followed by Nivolumab 3 mg/kg on day 22 of each cycle for a total of 2 cycles. Each cycle will be six weeks long. Ipilimumab and Nivolumab will occur on weeks 0 and 6 while Nivolumab alone will occur on weeks 3 and 9. Receives: Drug: Nivolumab; Drug: Ipilimumab; Procedure: Radical cystectomy |
| Cohort 3 | Experimental | Ipilimumab 3 mg/kg on day 1 each cycle and Nivolumab 1 mg/kg on day 1 of each cycle for a total of 3 cycles. Each cycle will be three weeks long and treatment will occur during weeks 0, 3, and 6. Receives: Drug: Nivolumab; Drug: Ipilimumab; Procedure: Radical cystectomy |
| Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible) | Experimental | Ipilimumab 3 mg/kg and Nivolumab 1 mg/kg on day 1, of each cycle, followed by Nivolumab 3 mg/kg on day 22 and Ipilimumab 3mg/kg and Nivolumab 1mg/kg on day 45. Receives: Drug: Nivolumab; Drug: Ipilimumab; Procedure: Radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who proceed to radical cystectomy and pelvic lymph node dissection (RC-PLND)
Measured: within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible MIBC, without delays due to treatment-related toxicities or progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start25 Apr 2018
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
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 Bladder CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a pilot study designed to evaluate neoadjuvant nivolumab and nivolumab in combination with ipilimumab in patients with muscle-invasive bladder cancer (MIBC) or urothelial cancers of the upper urinary tract (ureter or renal pelvis) \[UTUC\], who are ineligible for treatment with cisplatin-based chemotherapy. The study is designed with three sequential 15-patient cohorts.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Niglio, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520491
- Sponsor's protocol ID
- 18-042
- Status last verified
- Feb 2026
- First submitted
- 26 Apr 2018
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Giannakodimos I, Ziogou A, Giannakodimos A, Tzelepis K, Kratiras Z, Fragkiadis E, Zachos I, Tzortzis V, Chrisofos M, Charalampakis N. Neoadjuvant immunotherapy for muscle-invasive bladder cancer: a 2025 update. Immunotherapy. 2025 Apr;17(6):447-455. doi: 10.1080/1750743X.2025.2501929. Epub 2025 May 6.
PubMed 40329651
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety of Neoadjuvant Nivolumab Alone or in Combination With Ipilimumab for Cisplatin-Ineligible Patients With Muscle Invasive Bladder Cancer (CA209-9DJ)
- ClinicalTrials.gov ID
- NCT03520491
- Acronym / sponsor ID
- 18-042
- Conditions
- Bladder Cancer
- Keywords
- Immunotherapy, Nivolumab, Ipilimumab, 18-042
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 May 2018 (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.
The purpose of this study is to test if immunotherapy with nivolumab alone or in combination with ipilimumab is safe and does not delay the planned bladder cancer surgery. The investigators want to see if treatment with these drugs prior to surgery may decrease the size of the bladder cancer and thus could help make the surgery more successful.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a pilot study designed to evaluate neoadjuvant nivolumab and nivolumab in combination with ipilimumab in patients with muscle-invasive bladder cancer (MIBC) or urothelial cancers of the upper urinary tract (ureter or renal pelvis) [UTUC], who are ineligible for treatment with cisplatin-based chemotherapy. The study is designed with three sequential 15-patient cohorts.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Nivolumab, Procedure: Radical cystectomyNivolumab 3 mg/kg on day 1 of each cycle for a total of 5 cycles. Each cycle will be two weeks long and treatment will occur during weeks 0, 2, 4, 6, and 8. |
| Cohort 2 | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Procedure: Radical cystectomyIpilimumab 3 mg/kg and Nivolumab 1 mg/kg on day 1 of each cycle, followed by Nivolumab 3 mg/kg on day 22 of each cycle for a total of 2 cycles. Each cycle will be six weeks long. Ipilimumab and Nivolumab will occur on weeks 0 and 6 while Nivolumab alone will occur on weeks 3 and 9. |
| Cohort 3 | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Procedure: Radical cystectomyIpilimumab 3 mg/kg on day 1 each cycle and Nivolumab 1 mg/kg on day 1 of each cycle for a total of 3 cycles. Each cycle will be three weeks long and treatment will occur during weeks 0, 3, and 6. |
| Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible) | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Procedure: Radical cystectomyIpilimumab 3 mg/kg and Nivolumab 1 mg/kg on day 1, of each cycle, followed by Nivolumab 3 mg/kg on day 22 and Ipilimumab 3mg/kg and Nivolumab 1mg/kg on day 45. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed diagnosis of urothelial carcinoma of the bladder. Variant histology is acceptable if there is a predominant urothelial component.
- For MUSCLE-INVASIVE UROTHELIAL CANCER OF THE BLADDER (Cohorts 1 - 3):
- ° Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease. Patients with cT4a disease invading into the prostatic stroma with no cystoscopic confirmation of muscle invasion are eligible.
- For UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT (URETER OR RENAL PELVIS) (Cohort U):
- °Histologically confirmed high grade urothelial carcinoma of the upper tract and/or radiographically visible tumor stage T2-T4a N0/x M0 disease with positive selective urinary cytology. Hydronephrosis associated with tumor on imaging or biopsy will be considered invasive by definition. (Variant histology is acceptable if there is a predominant urothelial component)
Key exclusion criteria (26 listed)
- Prior treatment with systemic chemotherapy for urothelial cancer, including immune checkpoint inhibitors for non-muscle invasive bladder cancer. (Prior intravesical treatment such as BCG is allowed.)
- Prior bladder-directed radiotherapy (exclusion applies only to MIBC Cohorts 1 - 3).
- Presence of active autoimmune disease, symptoms, or conditions, with the following exceptions:
- °Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, asymptomatic laboratory evidence of autoimmune disease (e.g.: +ANA, +RF, anti-thyroglobulin antibodies), or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug. Inhaled or topical steroids, and adrenal replacement steroid doses are permitted in the absence of active autoimmune disease.
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 |
|---|---|---|
| NivolumabNivolumab 3 mg/kg or Nivolumab 1 mg/kg | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible) |
| IpilimumabIpilimumab 3 mg/kg | Drug | Cohort 2, Cohort 3, Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible) |
| Radical cystectomyRC-PLND is to take place within 60 days from the last dose of treatment.(After week 10 for cohort 1, after week 11 for cohort 2, and after week 9 for cohort 3.) | Procedure or surgery | Cohort 1, Cohort 2, Cohort 3, Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible) |
Primary outcome
number of patients who proceed to radical cystectomy and pelvic lymph node dissection (RC-PLND)
Time frame: within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible MIBC, without delays due to treatment-related toxicities or progressive disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 40329651Giannakodimos I, Ziogou A, Giannakodimos A, Tzelepis K, Kratiras Z, Fragkiadis E, Zachos I, Tzortzis V, Chrisofos M, Charalampakis N. Neoadjuvant immunotherapy for muscle-invasive bladder cancer: a 2025 update. Immunotherapy. 2025 Apr;17(6):447-455. doi: 10.1080/1750743X.2025.2501929. Epub 2025 May 6.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Scott Niglio, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ipilimumab and Radical cystectomy in people with Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 19 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 17 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 7 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
number of patients who proceed to radical cystectomy and pelvic lymph node dissection (RC-PLND) (time frame: within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible MIBC, without delays due to treatment-related toxicities or progressive disease). 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 NCT03520491, 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 17 Feb 2026.