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Tests treatment safety and results for Urothelial Carcinoma
Official title Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
ClinicalTrials.gov ID: NCT04617756
What this study is testing
What is Patients receiving neoadjuvant therapy before radical nephrectomy?
Patients receiving neoadjuvant therapy before radical nephrectomy is an investigational medicine, being studied as a potential treatment for urothelial carcinoma.
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
- Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively.
- 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
- Patient has been correctly informed and has given signed consent.
- Patient is covered by a health insurance scheme.
- Patients aged over 70 must have a G8 score (Soubeyran et al. 2014) of at least 14.
- Patient's body weight must be over 30kg
- Patient has high-grade urothelial carcinoma of the renal pelvis or ureter confirmed histologically (uteroscopic biopsy) or cytologically (urine...
You likely can't join if
- The patient is participating in another treatment trial;
- or is in an exclusion period determined by a previous study;
- or is under judicial protection, or is an adult under guardianship
- or refuses to sign the consent;
- or it is impossible to correctly inform the patient.
- The patient is pregnant or breastfeeding.
See the full eligibility criteria
- Patient has been correctly informed and has given signed consent.
- Patient is covered by a health insurance scheme.
- Patients aged over 70 must have a G8 score (Soubeyran et al. 2014) of at least 14.
- Patient's body weight must be over 30kg
- Patient has high-grade urothelial carcinoma of the renal pelvis or ureter confirmed histologically (uteroscopic biopsy) or cytologically (urine cytology).
- Presence of divergent histologies (i.e. squamous cell tumour, adenocarcinoma, small cell carcinoma, micropapillary variant) may also give rise to inclusion if there is a high prevalence (over 90%) of a urothelial...
- Presence of EITHER high-grade disease on the uteroscopic tumor biopsy
- OR Presence of high-grade disease on urine cytology AND infiltrative aspect of renal pelvis/ ureteral wall on the CT scan (presence of hydronephrosis will be considered invasive by definition) with negative cystoscopy.
- Or in the absence of histological evidence, the opinion of the multidisciplinary consultation meeting (RCP) will prevail for the analysis of the imaging and the potential inclusion of the patient in the study
- No prior systemic therapies.
- ECOG performance status 0 to 1.
- M0 No or N1 disease on CT scan.
- Required initial laboratory values :
- Absolute neutrophil count of over 1500 cells/mm²
- Platelet count of over 100,000 cells/mm3
- Hemoglobin over 9.0 g/dL
- Bilirubin below 1.5 times the Upper Limit of Normal for the institution
- Aspartase transaminase (ASAT) and Alanine transaminase (ALAT) below 2.5 x the Upper Limit of Normal for the institution.
- Alkaline phosphatase below 2.5 times the Upper Limit of Normal for the institution
- INR and aPTT below 1.5 times the Upper Limit of Normal for the institution.
- For Cohort 1 : An estimated glomerular filtration rate of over 60ml/min/1.73m² using the CKD-EPI and/or MDRD equation.
- For Cohort 2 : An estimated glomerular filtration rate of 40ml to 60ml/min/1.73m² using the CKD-EPI and/or MDRD equation.
- Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.
- Patients must have a life expectancy of at least 12 weeks.
- The patient is participating in another treatment trial;
- or is in an exclusion period determined by a previous study;
- or is under judicial protection, or is an adult under guardianship
- or refuses to sign the consent;
- or it is impossible to correctly inform the patient.
- The patient is pregnant or breastfeeding.
- Concomitant diagnosis of muscle invasive or in situ or high grade non muscle invasive urothelial carcinoma of the bladder.
- Evidence of NYHA functional class III or IV heart disease.
- Serious intercurrent medical or psychiatric illness, including serious active infection.
- Concomitant use of any other investigational drugs.
- Diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration.
- Additional malignancy within last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer that has undergone potentially curative therapy, stable (as...
- Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents...
- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV...
- Live vaccine received within 30 days prior to the first dose of trial treatment.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- History of allogenic organ transplantation.
- Uncontrolled intercurrent illness, including but not limited to, on-going or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab...
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Paris Cx 20, France
- Marseille, France
- Paris, France
- Pierre-Bénite, France
- Rennes, France
- Suresnes, France
- Toulouse, France
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 Paris, Paris Cx 20, France; Marseille, France; Paris, France; Pierre-Bénite, France; Rennes, France; Suresnes, France and 1 more location(s). 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.