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New treatment option for Muscle-Invasive Bladder Carcinoma
Official title Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT05203913
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for muscle-invasive bladder carcinoma.
Also referred to as Opdivo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this phase II study, eligible patients will be treated with maximal tumor resection and then started treatment within 8 weeks. Chemotherapy, Nivolumab and radiotherapy (RT) will be started on day one.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years old or older
- Histologic diagnosis of predominantly urothelial carcinoma of the bladder. Focal differentiation allowed other than small cell histology.
- Stage T2-T3 N0M0 (AJCC-TNM version 6) based on trans-urethral resection of bladder tumor (TURBT), CT or MRI imaging, +/- bimanual examination under...
- FDG-PET within 6 weeks from the start of treatments, showing no evidence of lymph nodes or metastatic disease.
- Attempt of complete trans urethral resection of bladder tumour (TURBT) within 56 days (8 weeks) prior to the start of chemoradiotherapy. If TURBT was...
You likely can't join if
- Prior systemic therapy for other urothelial tumours.
- Prior RT to the pelvis
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives...
- Malignancies other than urothelial cancer within 3 years prior to Cycle 1, Day 1:
- Patients with localized lower risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤ 7, and PSA at prostate cancer diagnosis ≤ 20 ng/mL [if...
- Patients with lower risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤ 7 and PSA ≤ 10 ng/mL) who are treatment-naive and undergoing...
See the full eligibility criteria
Who can join
- 18 years old or older
- Histologic diagnosis of predominantly urothelial carcinoma of the bladder. Focal differentiation allowed other than small cell histology.
- Stage T2-T3 N0M0 (AJCC-TNM version 6) based on trans-urethral resection of bladder tumor (TURBT), CT or MRI imaging, +/- bimanual examination under anaesthesia.
- FDG-PET within 6 weeks from the start of treatments, showing no evidence of lymph nodes or metastatic disease.
- Attempt of complete trans urethral resection of bladder tumour (TURBT) within 56 days (8 weeks) prior to the start of chemoradiotherapy. If TURBT was performed \> 8 weeks prior but a recent cystoscopy shows no residual...
- Life expectancy greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better
- Another primary cancer is allowed only if treated with curative intent at least 3 years prior to enrolment without evidence of recurrence or if the untreated cancer is clinically indolent (e.g., lower risk prostate...
- Patients must be considered able to tolerate systemic chemotherapy combined with pelvic intensity-modulated radiation therapy (IMRT) by the joint agreement of the participating radiation oncologist and medical...
- Able and willing to give written informed consent.
- For women of childbearing potential (WOCBP), study participants must use a contraceptive method that is highly effective (with a failure rate of \< 1% per year) for at least 5 months after the last dose of study...
- Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:
- Total bilirubin ≤1∙5 × the upper limit of normal (ULN).
- Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of their cancer).
- International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1∙5 × ULN. people who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence...
- Platelet count ≥100 000/mm3, haemoglobin \>9 g/dl, absolute neutrophil count \>1,500/mm3.
- Alkaline phosphatase limit ≤2∙5 × ULN (≤5 × ULN for patients with liver involvement of their cancer).
- Creatinine clearance greater than 40 ml/min as evaluated by Cockcroft-Gault formula.
What rules you out
- Prior systemic therapy for other urothelial tumours.
- Prior RT to the pelvis
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to enrolment.
- Malignancies other than urothelial cancer within 3 years prior to Cycle 1, Day 1:
- Patients with localized lower risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤ 7, and PSA at prostate cancer diagnosis ≤ 20 ng/mL [if measured]) treated with radical prostatectomy and without...
- Patients with lower risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤ 7 and PSA ≤ 10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.
- Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death \<5% at 5 years) are eligible provided they meet all the following criteria:
- Malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with...
- Pre-existing medical conditions precluding treatment (e.g., previous history of immune-related adverse reactions, pneumonitis, colitis, etc.)
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- Active tuberculosis
- For women of childbearing potential (WOCBP), study participants must use a contraceptive method that is highly effective (with a failure rate of \< 1% per year) for at least 5 months after the last dose of study...
- Received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor...
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor...
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Received or will receive a live vaccine within 4 weeks prior to first dose of study drug except for vaccine against SARS-CoViD2. Influenza vaccination should be given during influenza season only (approximately October...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan History of...
- Active infection requiring IV systemic therapy.
- Receipt of therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive...
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina. Patients with...
- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the course of the study
- Prior allogeneic stem cell or solid organ transplant
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or...
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Patients with active Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
- Not willing or unable to sign a consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.