Muscle-Invasive Bladder CarcinomaPhase 2NURE-ComboNCT04876313
An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo)
A Phase 2 study testing Nivolumab + Nab-paclitaxel and Nivolumab in people with Muscle-Invasive Bladder Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
To assess whether nivolumab+nab-paclitaxel combination results in patients with muscle-invasive bladder cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- What is being tested?
- Nivolumab + Nab-paclitaxel and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2022to Jun 2025
- Phase
- Phase 2
- 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
- Female or male subjects, >18 years of age, able to understand and give written informed consent.
- Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
- Fit and planned for RC (according to local guidelines).
- ECOG performance status score of 0 or 1.
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin ≥ 9 g/dL, ANC ≥ 1,500/ mm3, and Platelets ≥ 100,000/ μL).
- Adequate hepatic function (Bilirubin ≤ 1.5 IULN, AST and ALT ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin >3 g/dl).
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- Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication, and must not be lactating. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 4 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >2 years.
- Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.
- Clinical stage T2-T4aN0M0 MIBC, assessed by CT + PET/CT + mpMRI.
- The patient accepts to undergo RC.
- Ineligibility to receive cisplatin-based neoadjuvant chemotherapy based on Galsky's criteria (Galsky MD, et al. J Clin Oncol. 2011 Jun 10;29(17):2432-8) OR refusal to receive neoadjuvant cisplatin-based chemotherapy.
Who cannot join
- Has received prior systemic anti-cancer therapy including investigational agents and immunotherapy.
- Prior immunotherapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137.
- Has received prior radiotherapy on the bladder tumor.
- Have received a partial cystectomy.
- Refusal to undergo RC.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
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- Has received any antibiotics within 30 days prior to the first dose of study drug.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Participants with low-risk early stage prostate cancer defined as follows are not excluded; Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific antigen (PSA) < 10 ng/mL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation.
- Has severe hypersensitivity (≥Grade 3) to nivolumab or nab-paclitaxel and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Have active cardiac disease, defined as:
- Myocardial infarction or unstable angina pectoris within 6 months of C1D1
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation
- NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%
- Have known history of HIV-1/2 infection.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- High dose systemic corticosteroids (≥20 mg of prednisolone or its equivalent) are not allowed within 2 weeks of C1D1.
- Have received or are currently receiving (within the previous 2 weeks) antibiotics.
- Have a pre-existing motor or sensory neuropathy of a severity >= grade 2 by NCI-CTC criteria due to the potential for neuropathy of nab-paclitaxel.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Genitourinary Medical Oncology - IRCCS San Raffaele Hospital and Scientific Institute
Milan, MI, 20132
Andrea Necchi, +39 0226435789, necchi.andrea@hsr.it
Rossella Miotti, +39 0226435789, Miotti.rossella@unisr.it
About this study
Official title: An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer
To assess whether nivolumab+nab-paclitaxel combination results in patients with muscle-invasive bladder cancer
Read the detailed description
This is a Phase 2, single-center, open-label, non-randomized study in patients with muscle-invasive urothelial carcinoma of the bladder.
The general framework of the study will be as follows:
A transurethral resection of the bladder for biopsy, histological characterization, and local staging will be executed first. With the aim to improve the sensitivity of CT scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor, computed tomography (CT) scan, 18FDG-PET/CT scan, and multiparametric bladder MRI (mpMRI) will be done during screening and before cystectomy to stage and evaluate response.
Eligible patients will receive neoadjuvant treatment: 360 mg nivolumab IV on Day 1 plus 125 mg/m2 nab-paclitaxel on Day 1 and 8, in a 21-day cycle.
A total of 4 cycles are planned before surgery. Surgery will be planned at the time of study inclusion to be done within 3 weeks of the last dose of study drug.
Dose reductions will be applied depending on the severity of AEs, and treatment interruption or discontinuation criteria will be fully described in the protocol.
After surgery, patients will receive 12-month adjuvant therapy with nivolumab 360 mg IV, every 3 weeks.
RECIST v1.1 criteria will be used to assess patient response to treatment by determining tumor size and PFS. Screening assessments should be performed no more than 21 days prior to the start of study treatment. Following the screening assessment, subsequent assessments will be carried out after the administration of the study drugs prior to cystectomy. If an unscheduled assessment is performed and the patient has not progressed, the results should be reported at the next scheduled visit. The method of tumor assessment used at baseline e.g. CT or MRI scans chest, abdomen, pelvis, must be used at each sub-sequent follow-up assessment.
Patients will be monitored carefully for the development of adverse events and will be monitored for clinical and/or radiographic evidence of disease progression according to usual standards of clinical practice. Adverse experiences will be evaluated according to criteria outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Being tested
- Nivolumab + Nab-paclitaxel, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab + Nab-paclitaxelDrug
Also called Nivolumab + Abraxane
4x3 weekly cycles of 360 mg nivolumab + 125 mg/m^2 nab-paclitaxel IV on days 1 and 8
NivolumabDrug
Also called Adjuvant Nivolumab
360 mg IV Q3W x 13 cycles
| Study group | Role | What they receive |
|---|---|---|
| Combined Drugs | Experimental | Participants received 4x3 weekly cycles of 360 mg Nivolumab + 125 mg/m^2 Nab-paclitaxel IV on days 1 and 8, then they had cystectomy after that partecipants received adjuvant nivolumab 360 mg IV Q3W X13 cycles Receives: Drug: Nivolumab + Nab-paclitaxel; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
To assess whether nab-paclitaxel plus nivolumab results in pathological complete response (herein referred to as either "ypT0N0M0" or "pCR") in patients with clinical T2-4aN0M0 MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy. Absence of any residual viable tumor in the radical cystectomy specimen. Two independent pathologists, blinded to the study findings, with >10 years of experience in genitourinary tumors will independently evaluate the response.
Measured: Change from Screening after radical cystectomy
Secondary outcomes (5)
pathological downstaging
To evaluate the proportion of patients who will be pathological downstaged to ypT<=1N0M0.
Measured: screening, 14 days after final combined treatment, 3 weeks until 12 months post-radical cystectomy, 3 months until 12 months post-adjuvant nivolumab
radiological response
To evaluate radiological response on those patients with measurable disease. Response (CR and PR) will be assessed after the full neoadjuvant course of 4 cycles.
Measured: screening, 14 days after final combined treatment, 3 weeks until 12 months post-radical cystectomy, 3 months until 12 months post-adjuvant nivolumab
Number of participants with treatment related adverse events as assessed by CTCAE v5.0 and EAU recommendations
To evaluate the surgical and medical safety of neoadjuvant combination therapy, as well as of the adjuvant nivolumab therapy.
Measured: From date of Screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
event-free survival
To assess event-free survival in the total population and in the subgroups according to the pathological response.
Measured: From date of Screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
overall survival
To assess overall survival in the total population and in the subgroups according to the pathological response.
Measured: From date of Screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start27 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (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 Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with muscle-invasive urothelial bladder carcinoma, not eligible or denying standard neoadjuvant therapy
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Prof. Andrea Necchi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876313
- Sponsor's protocol ID
- NURE-Combo
- Other IDs
- 2020-005050-20
- Acronym
- NURE-Combo
- Status last verified
- Mar 2022
- First submitted
- 28 Apr 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mercinelli C, Moschini M, Cigliola A, Mattorre B, Tateo V, Basile G, Cogrossi LL, Maiorano BA, Patane DA, Raggi D, Pastorino GL, Re C, Colecchia M, Luciano R, Colombo R, Brembilla G, De Cobelli F, Briganti A, Pavlick DC, Ross JS, Montorsi F, Bellone M, Necchi A. First Results of NURE-Combo: A Phase II Study of Neoadjuvant Nivolumab and Nab-Paclitaxel, Followed by Postsurgical Adjuvant Nivolumab, for Muscle-Invasive Bladder Cancer. J Clin Oncol. 2024 Dec 10;42(35):4196-4205. doi: 10.1200/JCO.24.00576. Epub 2024 Sep 6.
PubMed 39241203
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04876313
- Acronym / sponsor ID
- NURE-Combo / NURE-Combo
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 May 2021 (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.
To assess whether nivolumab+nab-paclitaxel combination results in patients with muscle-invasive bladder cancer
Detailed description
This is a Phase 2, single-center, open-label, non-randomized study in patients with muscle-invasive urothelial carcinoma of the bladder.
The general framework of the study will be as follows:
A transurethral resection of the bladder for biopsy, histological characterization, and local staging will be executed first. With the aim to improve the sensitivity of CT scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor, computed tomography (CT) scan, 18FDG-PET/CT scan, and multiparametric bladder MRI (mpMRI) will be done during screening and before cystectomy to stage and evaluate response.
Eligible patients will receive neoadjuvant treatment: 360 mg nivolumab IV on Day 1 plus 125 mg/m2 nab-paclitaxel on Day 1 and 8, in a 21-day cycle.
A total of 4 cycles are planned before surgery. Surgery will be planned at the time of study inclusion to be done within 3 weeks of the last dose of study drug.
Dose reductions will be applied depending on the severity of AEs, and treatment interruption or discontinuation criteria will be fully described in the protocol.
After surgery, patients will receive 12-month adjuvant therapy with nivolumab 360 mg IV, every 3 weeks.
RECIST v1.1 criteria will be used to assess patient response to treatment by determining tumor size and PFS. Screening assessments should be performed no more than 21 days prior to the start of study treatment. Following the screening assessment, subsequent assessments will be carried out after the administration of the study drugs prior to cystectomy. If an unscheduled assessment is performed and the patient has not progressed, the results should be reported at the next scheduled visit. The method of tumor assessment used at baseline e.g. CT or MRI scans chest, abdomen, pelvis, must be used at each sub-sequent follow-up assessment.
Patients will be monitored carefully for the development of adverse events and will be monitored for clinical and/or radiographic evidence of disease progression according to usual standards of clinical practice. Adverse experiences will be evaluated according to criteria outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with muscle-invasive urothelial bladder carcinoma, not eligible or denying standard neoadjuvant therapy
| Arm | Type | Receives |
|---|---|---|
| Combined Drugs | Experimental | Drug: Nivolumab + Nab-paclitaxel, Drug: NivolumabParticipants received 4x3 weekly cycles of 360 mg Nivolumab + 125 mg/m^2 Nab-paclitaxel IV on days 1 and 8, then they had cystectomy after that partecipants received adjuvant nivolumab 360 mg IV Q3W X13 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female or male subjects, >18 years of age, able to understand and give written informed consent.
- Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
- Fit and planned for RC (according to local guidelines).
- ECOG performance status score of 0 or 1.
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin ≥ 9 g/dL, ANC ≥ 1,500/ mm3, and Platelets ≥ 100,000/ μL).
Key exclusion criteria (26 listed)
- Has received prior systemic anti-cancer therapy including investigational agents and immunotherapy.
- Prior immunotherapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137.
- Has received prior radiotherapy on the bladder tumor.
- Have received a partial cystectomy.
- Refusal to undergo RC.
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 |
|---|---|---|
| Nivolumab + Nab-paclitaxelAlso: Nivolumab + Abraxane4x3 weekly cycles of 360 mg nivolumab + 125 mg/m^2 nab-paclitaxel IV on days 1 and 8 | Drug | Combined Drugs |
| NivolumabAlso: Adjuvant Nivolumab360 mg IV Q3W x 13 cycles | Drug | Combined Drugs |
Primary outcome
Pathological complete response
Time frame: Change from Screening after radical cystectomy
To assess whether nab-paclitaxel plus nivolumab results in pathological complete response (herein referred to as either "ypT0N0M0" or "pCR") in patients with clinical T2-4aN0M0 MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy. Absence of any residual viable tumor in the radical cystectomy specimen. Two independent pathologists, blinded to the study findings, with >10 years of experience in genitourinary tumors will independently evaluate the response.
5 secondary outcomes
pathological downstaging
Time frame: screening, 14 days after final combined treatment, 3 weeks until 12 months post-radical cystectomy, 3 months until 12 months post-adjuvant nivolumab
radiological response
Time frame: screening, 14 days after final combined treatment, 3 weeks until 12 months post-radical cystectomy, 3 months until 12 months post-adjuvant nivolumab
Number of participants with treatment related adverse events as assessed by CTCAE v5.0 and EAU recommendations
Time frame: From date of Screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
event-free survival
Time frame: From date of Screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
overall survival
Time frame: From date of Screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 39241203Mercinelli C, Moschini M, Cigliola A, Mattorre B, Tateo V, Basile G, Cogrossi LL, Maiorano BA, Patane DA, Raggi D, Pastorino GL, Re C, Colecchia M, Luciano R, Colombo R, Brembilla G, De Cobelli F, Briganti A, Pavlick DC, Ross JS, Montorsi F, Bellone M, Necchi A. First Results of NURE-Combo: A Phase II Study of Neoadjuvant Nivolumab and Nab-Paclitaxel, Followed by Postsurgical Adjuvant Nivolumab, for Muscle-Invasive Bladder Cancer. J Clin Oncol. 2024 Dec 10;42(35):4196-4205. doi: 10.1200/JCO.24.00576. Epub 2024 Sep 6.
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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.
1 site 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 + Nab-paclitaxel and Nivolumab in people with Muscle-Invasive Bladder Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
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 13 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Necchi (+39 0226435789, necchi.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: Change from Screening after radical cystectomy). 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 NCT04876313, 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 6 Apr 2022.