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Purpose

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. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 caregiver and/or family member available will also be considered eligible - Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 12 weeks (84 days) prior to registration/randomization with one of the following: - Upper urinary tract mass on cross-sectional imaging or - Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology - NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice - Leukocytes >= 3,000/mcL (obtained =< 14 days prior to registration/randomization) - Platelets >= 100,000/mcL (obtained =< 14 days prior to registration/randomization) - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN for patients with Gilbert's disease) (obtained =< 14 days prior to registration/randomization) - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 14 days prior to registration/randomization) - 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 - 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 within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months - NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and 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 undetectable HCV viral load - 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 Functional Classification. To be eligible for this trial, patients should be class 2B or better - 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 by Crockroft-Gault formula or 24-hour creatinine clearance 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 neuropathy and/or hearing loss in keeping with SOC cisplatin contraindications. Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B - Patients that meet any of the following criteria will be registered and assigned to the cisplatin-ineligible Arm C if they meet other eligibility criteria: - Creatinine clearance > 15 ml/min and =< 50 ml/min or hearing loss grade >= 3, or neuropathy >= 2, or ECOG PS 2 - Patient must have an absolute neutrophil count (ANC) >= 1,000/mcL obtained =< 14 days prior to registration - Patient must have ECOG performance status 0-2 - Patients that meet the following criteria will be randomized to the cisplatin-eligible Arm A or Arm B: - Patient must have creatinine clearance of > 50ml/min, PS ECOG 0-1, absence of hearing loss grade >= 3, and/or neuropathy >= 2 - Patient must have an absolute neutrophil count (ANC) >= 1,500/mcL obtained =< 14 days prior to randomization - 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

Exclusion Criteria

  • Patients must not have any component of small cell/neuroendocrine carcinoma. Other variant histologic types are permitted provided the predominant (>= 50%) subtype is urothelial carcinoma - 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 potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) - 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 from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment - 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 axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) or other imaging or other criteria can be eligible based on investigator discretion). - NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scans 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 insignificant per the investigator (e.g. =< Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat - NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed - 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 radiation)]. Prior immune checkpoint inhibitor is not allowed. - Patient with history of >= pT4b, N+, and/or M1 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 regardless of time elapsed - 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 findings, and tuberculosis [TB] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last three months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements - 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 chemotherapy 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 bowel disease [IBD], colitis, or Crohn's disease), neuromuscular autoimmune condition, immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible - 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: - 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 premedications for hypersensitivity reactions (e.g. computed tomography [CT] scan premedication) - 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, stent placement or nephrostomy tube is not considered major surgery - Patient must not have history of allogenic organ transplantation

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (durvalumab, chemotherapy) 		Patients receive durvalumab IV over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
  • Procedure: Biopsy
    Undergo tissue biopsy
    Other names:
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Drug: Cisplatin
    Given IV
    Other names:
    • Abiplatin
    • Blastolem
    • Briplatin
    • CDDP
    • Cis-diammine-dichloroplatinum
    • Cis-diamminedichloridoplatinum
    • Cis-diamminedichloro Platinum (II)
    • Cis-diamminedichloroplatinum
    • Cis-dichloroammine Platinum (II)
    • Cis-platinous Diamine Dichloride
    • Cis-platinum
    • Cis-platinum II
    • Cis-platinum II Diamine Dichloride
    • Cismaplat
    • Cisplatina
    • Cisplatinum
    • Cisplatyl
    • Citoplatino
    • Citosin
    • Cysplatyna
    • DDP
    • Lederplatin
    • Metaplatin
    • Neoplatin
    • Peyrone's Chloride
    • Peyrone's Salt
    • Placis
    • Plastistil
    • Platamine
    • Platiblastin
    • Platiblastin-S
    • Platinex
    • Platinol
    • Platinol- AQ
    • Platinol-AQ
    • Platinol-AQ VHA Plus
    • Platinoxan
    • Platinum
    • Platinum Diamminodichloride
    • Platiran
    • Platistin
    • Platosin
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Drug: Doxorubicin Hydrochloride
    Given Iv
    Other names:
    • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    • ADM
    • Adriacin
    • Adriamycin
    • Adriamycin Hydrochloride
    • Adriamycin PFS
    • Adriamycin RDF
    • ADRIAMYCIN, HYDROCHLORIDE
    • Adriamycine
    • Adriblastina
    • Adriblastine
    • Adrimedac
    • Chloridrato de Doxorrubicina
    • DOX
    • DOXO-CELL
    • Doxolem
    • Doxorubicin HCl
    • Doxorubicin.HCl
    • Doxorubin
    • Farmiblastina
    • FI 106
    • FI-106
    • hydroxydaunorubicin
    • Rubex
  • Biological: Durvalumab
    Given IV
    Other names:
    • Imfinzi
    • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
    • MEDI-4736
    • MEDI4736
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Methotrexate
    Given IV
    Other names:
    • Abitrexate
    • Alpha-Methopterin
    • Amethopterin
    • Brimexate
    • CL 14377
    • CL-14377
    • Emtexate
    • Emthexat
    • Emthexate
    • Farmitrexat
    • Fauldexato
    • Folex
    • Folex PFS
    • Lantarel
    • Ledertrexate
    • Lumexon
    • Maxtrex
    • Medsatrexate
    • Metex
    • Methoblastin
    • Methotrexate LPF
    • Methotrexate Methylaminopterin
    • Methotrexatum
    • Metotrexato
    • Metrotex
    • Mexate
    • Mexate-AQ
    • MTX
    • Novatrex
    • Rheumatrex
    • Texate
    • Tremetex
    • Trexeron
    • Trixilem
    • WR-19039
  • Biological: Pegfilgrastim
    Given via injection
    Other names:
    • Dulastin
    • Filgrastim SD-01
    • filgrastim-SD/01
    • Fulphila
    • HSP-130
    • Jinyouli
    • Neulasta
    • Neulastim
    • Neupopeg
    • Nyvepria
    • PEG-filgrastim
    • Pegcyte
    • Pegfilgrastim Biosimilar HSP-130
    • Pegfilgrastim Biosimilar Nyvepria
    • Pegfilgrastim Biosimilar Pegcyte
    • Pegfilgrastim Biosimilar PF-06881894
    • Pegfilgrastim Biosimilar Udenyca
    • Pegfilgrastim Biosimilar Ziextenzo
    • Pegfilgrastim-apgf
    • Pegfilgrastim-bmez
    • Pegfilgrastim-cbqv
    • Pegfilgrastim-jmdb
    • Pegylated G-CSF
    • Pegylated GCSF
    • Pegylated Granulocyte Colony Stimulating Factor
    • PF-06881894
    • SD-01
    • SD-01 sustained duration G-CSF
    • Tripegfilgrastim
    • Udenyca
    • Ziextenzo
  • Procedure: Therapeutic Conventional Surgery
    Undergo surgery
  • Drug: Vinblastine Sulfate
    Given Iv
    Other names:
    • 29060 LE
    • 29060-LE
    • Exal
    • Velban
    • Velbe
    • Velsar
    • VINCALEUKOBLASTINE
Active Comparator
Arm B (chemotherapy) 		Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
  • Procedure: Biopsy
    Undergo tissue biopsy
    Other names:
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Drug: Cisplatin
    Given IV
    Other names:
    • Abiplatin
    • Blastolem
    • Briplatin
    • CDDP
    • Cis-diammine-dichloroplatinum
    • Cis-diamminedichloridoplatinum
    • Cis-diamminedichloro Platinum (II)
    • Cis-diamminedichloroplatinum
    • Cis-dichloroammine Platinum (II)
    • Cis-platinous Diamine Dichloride
    • Cis-platinum
    • Cis-platinum II
    • Cis-platinum II Diamine Dichloride
    • Cismaplat
    • Cisplatina
    • Cisplatinum
    • Cisplatyl
    • Citoplatino
    • Citosin
    • Cysplatyna
    • DDP
    • Lederplatin
    • Metaplatin
    • Neoplatin
    • Peyrone's Chloride
    • Peyrone's Salt
    • Placis
    • Plastistil
    • Platamine
    • Platiblastin
    • Platiblastin-S
    • Platinex
    • Platinol
    • Platinol- AQ
    • Platinol-AQ
    • Platinol-AQ VHA Plus
    • Platinoxan
    • Platinum
    • Platinum Diamminodichloride
    • Platiran
    • Platistin
    • Platosin
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Drug: Doxorubicin Hydrochloride
    Given Iv
    Other names:
    • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    • ADM
    • Adriacin
    • Adriamycin
    • Adriamycin Hydrochloride
    • Adriamycin PFS
    • Adriamycin RDF
    • ADRIAMYCIN, HYDROCHLORIDE
    • Adriamycine
    • Adriblastina
    • Adriblastine
    • Adrimedac
    • Chloridrato de Doxorrubicina
    • DOX
    • DOXO-CELL
    • Doxolem
    • Doxorubicin HCl
    • Doxorubicin.HCl
    • Doxorubin
    • Farmiblastina
    • FI 106
    • FI-106
    • hydroxydaunorubicin
    • Rubex
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Methotrexate
    Given IV
    Other names:
    • Abitrexate
    • Alpha-Methopterin
    • Amethopterin
    • Brimexate
    • CL 14377
    • CL-14377
    • Emtexate
    • Emthexat
    • Emthexate
    • Farmitrexat
    • Fauldexato
    • Folex
    • Folex PFS
    • Lantarel
    • Ledertrexate
    • Lumexon
    • Maxtrex
    • Medsatrexate
    • Metex
    • Methoblastin
    • Methotrexate LPF
    • Methotrexate Methylaminopterin
    • Methotrexatum
    • Metotrexato
    • Metrotex
    • Mexate
    • Mexate-AQ
    • MTX
    • Novatrex
    • Rheumatrex
    • Texate
    • Tremetex
    • Trexeron
    • Trixilem
    • WR-19039
  • Biological: Pegfilgrastim
    Given via injection
    Other names:
    • Dulastin
    • Filgrastim SD-01
    • filgrastim-SD/01
    • Fulphila
    • HSP-130
    • Jinyouli
    • Neulasta
    • Neulastim
    • Neupopeg
    • Nyvepria
    • PEG-filgrastim
    • Pegcyte
    • Pegfilgrastim Biosimilar HSP-130
    • Pegfilgrastim Biosimilar Nyvepria
    • Pegfilgrastim Biosimilar Pegcyte
    • Pegfilgrastim Biosimilar PF-06881894
    • Pegfilgrastim Biosimilar Udenyca
    • Pegfilgrastim Biosimilar Ziextenzo
    • Pegfilgrastim-apgf
    • Pegfilgrastim-bmez
    • Pegfilgrastim-cbqv
    • Pegfilgrastim-jmdb
    • Pegylated G-CSF
    • Pegylated GCSF
    • Pegylated Granulocyte Colony Stimulating Factor
    • PF-06881894
    • SD-01
    • SD-01 sustained duration G-CSF
    • Tripegfilgrastim
    • Udenyca
    • Ziextenzo
  • Procedure: Therapeutic Conventional Surgery
    Undergo surgery
  • Drug: Vinblastine Sulfate
    Given Iv
    Other names:
    • 29060 LE
    • 29060-LE
    • Exal
    • Velban
    • Velbe
    • Velsar
    • VINCALEUKOBLASTINE
Experimental
Arm C (durvalumab, gemcitabine hydrochloride) 		Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
  • Procedure: Biopsy
    Undergo tissue biopsy
    Other names:
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Biological: Durvalumab
    Given IV
    Other names:
    • Imfinzi
    • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
    • MEDI-4736
    • MEDI4736
  • Drug: Gemcitabine Hydrochloride
    Given IV
    Other names:
    • dFdCyd
    • Difluorodeoxycytidine Hydrochloride
    • Gemcitabine HCI
    • Gemzar
    • LY-188011
    • LY188011
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Procedure: Therapeutic Conventional Surgery
    Undergo surgery

Recruiting Locations

Kingman Regional Medical Center
Kingman, Arizona 86401
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Sutter Auburn Faith Hospital
Auburn, California 95602
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

City of Hope Comprehensive Cancer Center
Duarte, California 91010
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

Palo Alto Medical Foundation-Fremont
Fremont, California 94538
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Memorial Medical Center
Modesto, California 95355
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California 95065
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

UCHealth Greeley Hospital
Greeley, Colorado 80631
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
Contact:
Site Public Contact
720-848-0650

Medical Center of the Rockies
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Site Public Contact
202-877-8839

Sibley Memorial Hospital
Washington, District of Columbia 20016
Contact:
Site Public Contact
202-243-2373
jquiver1@jhmi.edu

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015

Emory University Hospital Midtown
Atlanta, Georgia 30308
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888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
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404-778-1868

Advocate Good Shepherd Hospital
Barrington, Illinois 60010
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847-842-4847

Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
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773-296-5360

AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
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630-929-6129
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Carle at The Riverfront
Danville, Illinois 61832
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
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217-876-4762
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Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
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630-275-1270
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Carle Physician Group-Effingham
Effingham, Illinois 62401
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Crossroads Cancer Center
Effingham, Illinois 62401
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217-876-4762
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Advocate Sherman Hospital
Elgin, Illinois 60123
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847-429-2907

Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
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708-799-9995

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
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800-446-5532
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Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
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217-876-4762
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Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
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800-323-8622

Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
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Southern Illinois University School of Medicine
Springfield, Illinois 62702
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217-545-7929

Springfield Clinic
Springfield, Illinois 62702
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800-444-7541

Carle Cancer Center
Urbana, Illinois 61801
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800-446-5532
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Reid Health
Richmond, Indiana 47374
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937-528-2900
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University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa 52722
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563-355-7733
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University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
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800-237-1225

University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
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859-257-3379

East Jefferson General Hospital
Metairie, Louisiana 70006
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504-210-3539
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LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
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Harold Alfond Center for Cancer Care
Augusta, Maine 04330
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207-626-4855

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine 04005
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MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine 04073
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Maine Medical Partners - South Portland
South Portland, Maine 04106
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207-396-8670
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Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
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410-955-8804
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UMass Memorial Medical Center - University Campus
Worcester, Massachusetts 01655
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508-856-3216
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Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
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734-712-7251
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Saint Joseph Mercy Brighton
Brighton, Michigan 48114
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
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Saint Joseph Mercy Canton
Canton, Michigan 48188
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
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Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
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Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
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Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
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Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
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810-762-8038
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Genesee Hematology Oncology PC
Flint, Michigan 48503
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810-762-8038
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Genesys Hurley Cancer Institute
Flint, Michigan 48503
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810-762-8038
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
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734-712-7251
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Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
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313-343-3166
karen.forman@ascension.org

21st Century Oncology-Pontiac
Pontiac, Michigan 48341
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248-858-6215
Emily.Crofts@trinity-health.org

Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
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734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
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734-712-7251
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Huron Gastroenterology PC
Ypsilanti, Michigan 48106
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734-712-7251
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
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734-712-7251
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Mercy Hospital
Coon Rapids, Minnesota 55433
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952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
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952-993-1517
mmcorc@healthpartners.com

Mayo Clinic in Rochester
Rochester, Minnesota 55905
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855-776-0015

Regions Hospital
Saint Paul, Minnesota 55101
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952-993-1517
mmcorc@healthpartners.com

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
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573-334-2230
sfmc@sfmc.net

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
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314-251-7066

OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
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702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
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702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
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702-384-0013
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Hackensack University Medical Center
Hackensack, New Jersey 07601
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201-996-2879

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
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732-235-7356

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
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505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
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919-587-9084
jfields@cancersmoc.com

Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
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919-587-9084
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Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
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910-587-9084
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Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
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336-713-6771

Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Contact:
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937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital South
Centerville, Ohio 45459
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937-528-2900
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Dayton Blood and Cancer Center
Dayton, Ohio 45409
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937-276-8320

Miami Valley Hospital
Dayton, Ohio 45409
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937-528-2900
clinical.trials@daytonncorp.org

Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
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937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
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937-528-2900
clinical.trials@daytonncorp.org

Armes Family Cancer Center
Findlay, Ohio 45840
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937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
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937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
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937-528-2900
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Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
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937-569-7515

Greater Dayton Cancer Center
Kettering, Ohio 45409
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937-528-2900
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Kettering Medical Center
Kettering, Ohio 45429
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937-528-2900
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Upper Valley Medical Center
Troy, Ohio 45373
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937-528-2900
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Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
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877-231-4440

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
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405-271-8777
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UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
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412-389-5208
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UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
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724-838-1900

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
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717-531-3779
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UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
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412-389-5208
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University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
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800-474-9892

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
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215-600-9151
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University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
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412-647-8073

UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
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412-367-6454

UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
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412-502-3920

UPMC Cancer Center-Washington
Washington, Pennsylvania 15301
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ecog.rss@jimmy.harvard.edu

Parkland Memorial Hospital
Dallas, Texas 75235
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214-590-5582
canceranswerline@UTSouthwestern.edu

UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas 75237
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214-648-7097
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UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
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214-648-7097
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UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
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214-648-7097
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UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
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972-669-7044
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FHCC South Lake Union
Seattle, Washington 98109
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800-804-8824

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
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800-804-8824

University of Washington Medical Center - Montlake
Seattle, Washington 98195
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800-804-8824

ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
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920-364-3604
ResearchDept@thedacare.org

Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
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414-302-2304
ncorp@aurora.org

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
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800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
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414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
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414-302-2304
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Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
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414-302-2304
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Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
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414-302-2304
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Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
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414-302-2304
ncorp@aurora.org

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
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800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
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414-302-2304
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Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
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414-302-2304
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Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
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414-302-2304
ncorp@aurora.org

Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
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800-782-8581
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ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
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research.institute@phci.org

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
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262-928-7878

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
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414-302-2304
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Aurora Cancer Care-Racine
Racine, Wisconsin 53406
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414-302-2304
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
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800-782-8581
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Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
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414-302-2304
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Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
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800-782-8581
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Aurora Medical Center in Summit
Summit, Wisconsin 53066
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414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
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414-302-2304
ncorp@aurora.org

ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
Contact:
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262-928-7632

UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Contact:
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262-928-5539
Chanda.miller@phci.org

ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin 54981
Contact:
Site Public Contact
920-364-3605
ResearchDept@thedacare.org

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

More Details

NCT ID
NCT04628767
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVES: I. To compare event-free survival (EFS) between patients with upper tract urothelial cancer (UTUC) randomized to neoadjuvant accelerated methotrexate, vinblastine, adriamycin, cisplatin (aMVAC) alone or in combination with durvalumab. (Cisplatin eligible patients [Arms A and B]) II. Evaluation of pathologic complete response at radical nephroureterectomy (RNU) (pathologic complete response [pCR], pT0N0/ Nx). (Cisplatin ineligible patients [Arm C]). SECONDARY OBJECTIVES: I. To assess pathologic complete response (pCR) at surgery. (Cisplatin eligible cohort) II. Event-free survival (EFS) will be evaluated for the cisplatin ineligible cohort as a secondary endpoint. (Cisplatin ineligible cohort) III. Overall survival in all, and by post chemotherapy response (ypCR, yp =< T1N0, yp >= T2Nany). (All patients) IV. To evaluate disease-free survival (DFS) in each arm of the trial separately. (All patients) V. To evaluate cancer-specific survival of patients in each arm of the trial separately. (All patients) VI. To evaluate renal function outcomes following systemic treatment and following surgery ([RNU) in each arm of the trial separately. (All patients) VII. To evaluate safety and tolerability of neoadjuvant aMVAC alone or in combination with durvalumab prior to RNU. (All patients) OUTLINE: Patients eligible for cisplatin are randomized to Arms A or B. Patients ineligible for cisplatin are assigned to Arm C. ARM A: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. ARM B: Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. ARM C: Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed up within 30 days and then every 3-6 months for up to 5 years from study entry.

Notice

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