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New treatment option for Renal Pelvis and Ureter Urothelial Carcinoma
Official title Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
ClinicalTrials.gov ID: NCT04628767
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal pelvis and ureter urothelial carcinoma.
Also referred to as Abiplatin, Blastolem.
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
- This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- Phase 3: a large, late-stage study
- Time commitment: about 5 years
- Which group you join is decided by chance.
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
- STEP 1 REGISTRATION AND RANDOMIZATION
- Patients must be \>= 18 years of age
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making...
- Patient must have a diagnosis of high grade upper tract urothelial carcinoma expected within 14 weeks (98 days) prior to registration/randomization...
- Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or tumor directly visualized during upper urinary...
See the full eligibility criteria
Who can join
- STEP 1 REGISTRATION AND RANDOMIZATION
- Patients must be \>= 18 years of age
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or...
- Patient must have a diagnosis of high grade upper tract urothelial carcinoma expected within 14 weeks (98 days) prior to registration/randomization with one of the following:
- Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or tumor directly visualized during upper urinary tract endoscopy
- High grade cytology and clinically estimated invasive upper urinary tract mass on cross-sectional imaging (e.g., including presence of tumor-related hydronephrosis) or tumor directly visualized during upper urinary...
- NOTE: Universal histologic testing of UTUC with additional studies, such as immunohistochemistry and/or microsatellite instability, is strongly recommended to identify patients with high probability of Lynch-related or...
- Due to the anatomy of upper urinary tract and lack of muscularis propria, pathologic evidence of cT2 on biopsy is usually not possible
- Patients must not have any component of small cell/neuroendocrine carcinoma. Other histologic subtypes (variants) are permitted provided the half or predominant (\>= 50%) subtype is conventional urothelial carcinoma
- Leukocytes \>= 3,000/mcL (obtained =\< 14 days prior to registration/randomization)
- Platelets \>= 100,000/mcL (obtained =\< 14 days prior to registration/randomization)
- Total bilirubin =\< 1.2 mg/dL (or ≤ 2 mg/dLfor patients with Gilbert's disease)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2 x institutional ULN (obtained =\< 14 days prior...
- Hemoglobin (Hgb) \>= 9 g/dL (obtained =\< 14 days prior to registration/randomization)
- NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator
- Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing...
- Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse...
- Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (\>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings \>=1.5 cm short...
- NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scan to evaluate for bone metastasis at the discretion of local provider.
- Patient must meet below criteria for prior/current malignancy history:
- Non-urothelial cancer malignancy history:
- Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically...
- NOTE: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Urothelial cancer malignancy history:
- Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:
- T0, Ta or Tis at any time
- T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy [e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with...
- Patient with history of \>= pT4b, N+, and/or M1 UC is not eligible.
- NOTE: Patients in whom concomitant or prior bladder/urethra predominant (\>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (\< cT1 N0) are eligible...
- Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic...
- Patient must not have received prior radiation therapy to \>= 25% of the bone marrow for other diseases
- Patient must not have received prior systemic anthracycline therapy
- NOTE: Patients who have received prior intravesical therapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible
- Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration/randomization or any history of inflammatory bowel disease (inflammatory...
- Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion and are allowed:
- Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment
- Steroids as pre-medications for hypersensitivity reactions (e.g. computed tomography [CT] pre-medication)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration/randomization are eligible for this trial
- NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be...
- NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count \ = 250 cells/mcL within 7 days of registration/randomization
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab
- Patient must not have had a major surgical procedure within 28 days prior to registration/randomization
- NOTE: Cystoscopy/ureteroscopy/TURBT, stent placement or nephrostomy tube is not considered major surgery
- Patient must not have history of allogenic organ transplantation
- Patient must have a body weight of \> 30 kg
- Patient must have life expectancy of \>= 12 weeks
- Patient must have creatinine clearance \> 15 ml/min as estimated by Cockcroft-Gault formula or glomerular filtration rate (GFR) \> 15 ml/min/1.73m\^2 within 28 days prior to registration/randomization
- NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral...
- Patients that meet any of the following four criteria will be registered to the cisplatin-ineligible Arm C if they meet other eligibility criteria:
- Creatinine clearance \> 15 ml/min and =\ 15ml/min/1.73m\^2 and ≤ 50 ml/min/1.73 m\^2
- Hearing loss \>= 3
- Neuropathy \>= 2
- ECOG performance status 2
- In addition, the patient must have an absolute neutrophil count (ANC) \>= 1,000/mcL obtained =\< 14 days prior to registration
- Patients that meet all of the following four criteria will be assigned by chance to the cisplatin-eligible Arm A or Arm B:
- Creatinine clearance \> 50ml/min (estimated by Cockcroft-Gault formula) or GFR \> 50ml/min/1.73m\^2
- ECOG performance status 0-1
- Hearing loss grade 0-2
- Neuropathy 0-1
- In addition, the patient must have an absolute neutrophil count (ANC) \>= 1,500/mcL obtained =\< 14 days prior to randomization
- Also, the patient must have left ventricular ejection fraction (LVEF) \>= 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Kingman, Arizona, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Auburn, California, United States
- Berkeley, California, United States
- Duarte, California, United States
- Fremont, California, United States
- La Jolla, California, United States
- Modesto, California, United States
- Mountain View, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Cruz, California, United States
- Santa Rosa, California, United States
- Sunnyvale, California, United States
- Vallejo, California, United States
- Aurora, Colorado, United States
+ 181 more site(s).
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Kingman, Arizona, United States; Fort Smith, Arkansas, United States; Little Rock, Arkansas, United States; Auburn, California, United States; Berkeley, California, United States; Duarte, California, United States and 195 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.