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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 Sex
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 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 tract endoscopy - NOTE: Universal histologic testing of UTUC with additional studies, such as immunohistochemistry or microsatellite instability, is strongly recommended to identify patients with high probability of Lynch-related or other germline mutation related cancers whom clinicians should refer for genetic counseling and germline testing (this is not required for eligibility) - Due to the anatomy of upper urinary tract and lack of muscularis propria, pathologic evidence of cT2 on biopsy is usually not possible - 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 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 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 neuropathy and/or hearing loss in keeping with recommended cisplatin contraindications. Patients who are cisplatin-eligible will be randomized to either Arm A or Arm B and patients who are cisplatin-ineligible will be registered to Arm C - 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 =< 50 ml/min (estimated by Cockcroft-Gault formula) or GFR > 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 randomized to the cisplatin-eligible Arm A or Arm B: - Creatinine clearance of > 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 0-2 - 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

Exclusion Criteria

  • 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 - 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 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 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. - 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 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 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) or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations in the three months prior to registration 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], e.g. ulcerative 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 pre-medications for hypersensitivity reactions (e.g. computed tomography [CT] pre-medication) - 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 Procedure
    Undergo tissue biopsy
    Other names:
    • Biopsy
    • 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
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • 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
    • FI106
    • 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
    • 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
    • Jylamvo
    • 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
    • Fylnetra
    • G-Lasta
    • 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-fpgk
    • Pegfilgrastim-jmdb
    • Pegfilgrastim-pbbk
    • Pegylated G-CSF
    • Pegylated GCSF
    • Pegylated Granulocyte Colony Stimulating Factor
    • PF-06881894
    • SD-01
    • SD-01 sustained duration G-CSF
    • Stimufend
    • 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 Procedure
    Undergo tissue biopsy
    Other names:
    • Biopsy
    • 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
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • 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
    • FI106
    • 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
    • Jylamvo
    • 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
    • Fylnetra
    • G-Lasta
    • 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-fpgk
    • Pegfilgrastim-jmdb
    • Pegfilgrastim-pbbk
    • Pegylated G-CSF
    • Pegylated GCSF
    • Pegylated Granulocyte Colony Stimulating Factor
    • PF-06881894
    • SD-01
    • SD-01 sustained duration G-CSF
    • Stimufend
    • 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 Procedure
    Undergo tissue biopsy
    Other names:
    • Biopsy
    • 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
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • 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
    • MEDI-4736
    • MEDI4736
  • Drug: Gemcitabine Hydrochloride
    Given IV
    Other names:
    • dFdCyd
    • Difluorodeoxycytidine Hydrochloride
    • Gemcitabine HCI
    • Gemzar
    • LY 188011
    • 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 5301067, Arizona 5551752 86401
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

City of Hope Comprehensive Cancer Center
Duarte 5344147, California 5332921 91010
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

Stanford Cancer Institute Palo Alto
Palo Alto 5380748, California 5332921 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

UC San Diego Medical Center - Hillcrest
San Diego 5391811, California 5332921 92103
Contact:
Site Public Contact
rhabbaba@health.ucsd.edu

UCHealth University of Colorado Hospital
Aurora 5412347, Colorado 5417618 80045
Contact:
Site Public Contact
720-848-0650

UCHealth - Cherry Creek
Denver 5419384, Colorado 5417618 80206
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Poudre Valley Hospital
Fort Collins 5577147, Colorado 5417618 80524
Contact:
Site Public Contact
970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins 5577147, Colorado 5417618 80528
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

UCHealth Greeley Hospital
Greeley 5577592, Colorado 5417618 80631
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

UCHealth Highlands Ranch Hospital
Highlands Ranch 5425043, Colorado 5417618 80129
Contact:
Site Public Contact
720-848-0650

UCHealth Lone Tree Health Center
Lone Tree 5429208, Colorado 5417618 80124
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Medical Center of the Rockies
Loveland 5579368, Colorado 5417618 80538
Contact:
Site Public Contact
970-203-7083

MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
Site Public Contact
202-877-8839

Sibley Memorial Hospital
Washington D.C. 4140963, District of Columbia 4138106 20016
Contact:
Site Public Contact
202-243-2373
jquiver1@jhmi.edu

Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224-9980
Contact:
Site Public Contact
855-776-0015

Emory University Hospital Midtown
Atlanta 4180439, Georgia 4197000 30308
Contact:
Site Public Contact
888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
Contact:
Site Public Contact
404-778-1868

Emory Decatur Hospital
Decatur 4191124, Georgia 4197000 30033
Contact:
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440-778-1868
clinicaltrialsoncology@dekalbmedical.org

Saint Alphonsus Cancer Care Center-Nampa
Nampa 5601933, Idaho 5596512 83687
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Advocate Good Shepherd Hospital
Barrington 4884116, Illinois 4896861 60010
Contact:
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847-842-4847

SIH Cancer Institute
Carterville 4235311, Illinois 4896861 62918
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618-985-3333
clinical.research@sih.net

Advocate Illinois Masonic Medical Center
Chicago 4887398, Illinois 4896861 60657
Contact:
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773-296-5360

AMG Crystal Lake - Oncology
Crystal Lake 4889229, Illinois 4896861 60014
Contact:
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630-929-6129
advocateresearch@advocate.com

Cancer Care Specialists of Illinois - Decatur
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Advocate Good Samaritan Hospital
Downers Grove 4890119, Illinois 4896861 60515
Contact:
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630-275-1270
Barbara.barhamand@advocatehealth.com

Crossroads Cancer Center
Effingham 4237727, Illinois 4896861 62401
Contact:
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217-876-4762
morganthaler.jodi@mhsil.com

Advocate Sherman Hospital
Elgin 4890864, Illinois 4896861 60123
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847-429-2907

Advocate South Suburban Hospital
Hazel Crest 4895416, Illinois 4896861 60429
Contact:
Site Public Contact
708-799-9995

AMG Libertyville - Oncology
Libertyville 4899739, Illinois 4896861 60048
Contact:
Site Public Contact
630-929-6129
advocateresearch@advocatehealth.com

Cancer Care Center of O'Fallon
O'Fallon 4245926, Illinois 4896861 62269
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217-876-4762
morganthaler.jodi@mhsil.com

Advocate Christ Medical Center
Oak Lawn 4904365, Illinois 4896861 60453-2699
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800-323-8622

Advocate Lutheran General Hospital
Park Ridge 4905367, Illinois 4896861 60068
Contact:
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847-384-3621

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield 4250542, Illinois 4896861 62702
Contact:
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800-444-7541

University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf 4848489, Iowa 4862182 52722
Contact:
Site Public Contact
563-355-7733
katherine-daprile@uiowa.edu

University of Iowa/Holden Comprehensive Cancer Center
Iowa City 4862034, Iowa 4862182 52242
Contact:
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800-237-1225

University of Kentucky/Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
Contact:
Site Public Contact
859-257-3379

Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987 70809
Contact:
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225-215-1353
clinicalresearch@marybird.com

Mary Bird Perkins Cancer Center - Metairie
Metairie 4333177, Louisiana 4331987 70002
Contact:
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504-584-6990

East Jefferson General Hospital
Metairie 4333177, Louisiana 4331987 70006
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie 4333177, Louisiana 4331987 70006
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504-210-3539
emede1@lsuhsc.edu

University Medical Center New Orleans
New Orleans 4335045, Louisiana 4331987 70112
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504-210-3539
emede1@lsuhsc.edu

Harold Alfond Center for Cancer Care
Augusta 4957003, Maine 4971068 04330
Contact:
Site Public Contact
207-626-4855

MaineHealth Cancer Care and IV Therapy - Sanford
Sanford 4977762, Maine 4971068 04073
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

MaineHealth Cancer Care Center of York County
Sanford 4977762, Maine 4971068 04073
Contact:
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207-459-1600

MaineHealth Cancer Care and IV Therapy - South Portland
South Portland 4979244, Maine 4971068 04106
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore 4347778, Maryland 4361885 21287
Contact:
Site Public Contact
410-955-8804
jhcccro@jhmi.edu

UMass Memorial Medical Center - University Campus
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Site Public Contact
508-856-3216
cancer.research@umassmed.edu

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor 4984247, Michigan 5001836 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton 4986994, Michigan 5001836 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
Brighton 4986994, Michigan 5001836 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton 4987990, Michigan 5001836 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
Canton 4987990, Michigan 5001836 48188
Contact:
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734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Hematology Oncology Consultants-Clarkston
Clarkston 4988997, Michigan 5001836 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Clarkston 4988997, Michigan 5001836 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Cancer Hematology Centers - Flint
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesys Hurley Cancer Institute
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia 4999837, Michigan 5001836 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Henry Ford Saint John Hospital - Macomb Medical
Macomb 5000473, Michigan 5001836 48044
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

Michigan Healthcare Professionals Pontiac
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Newland Medical Associates-Pontiac
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

MyMichigan Medical Center Saginaw
Saginaw 5007989, Michigan 5001836 48601
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

MyMichigan Medical Center Tawas
Tawas City 5011900, Michigan 5001836 48764
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Huron Gastroenterology PC
Ypsilanti 5015688, Michigan 5001836 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti 5015688, Michigan 5001836 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Mercy Hospital
Coon Rapids 5022025, Minnesota 5037779 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood 5036588, Minnesota 5037779 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Site Public Contact
855-776-0015

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park 5045021, Minnesota 5037779 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul 5045360, Minnesota 5037779 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Lakeview Hospital
Stillwater 5048814, Minnesota 5037779 55082
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Francis Medical Center
Cape Girardeau 4379966, Missouri 4398678 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Parkland Health Center - Farmington
Farmington 4386289, Missouri 4398678 63640
Contact:
Site Public Contact
314-996-5569

Sainte Genevieve County Memorial Hospital
Sainte Genevieve 4407294, Missouri 4398678 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Missouri Baptist Medical Center
St Louis 4407066, Missouri 4398678 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066

Missouri Baptist Sullivan Hospital
Sullivan 4410669, Missouri 4398678 63080
Contact:
Site Public Contact
314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills 4410836, Missouri 4398678 63127
Contact:
Site Public Contact
314-996-5569

OptumCare Cancer Care at Seven Hills
Henderson 5505411, Nevada 5509151 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas 5506956, Nevada 5509151 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas 5506956, Nevada 5509151 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Saint Barnabas Medical Center
Livingston 5100572, New Jersey 5101760 07039
Contact:
Site Public Contact
973-322-2934
joanne.loeb@rwjbh.org

Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08903
Contact:
Site Public Contact
732-235-7356

Community Medical Center
Toms River 4504476, New Jersey 5101760 08755
Contact:
Site Public Contact
732-557-8294
Lennette.Gonzales@rwjbh.org

Southeastern Medical Oncology Center-Clinton
Clinton 4461101, North Carolina 4482348 28328
Contact:
Site Public Contact
919-587-9084
jfields@cancersmoc.com

Southeastern Medical Oncology Center-Goldsboro
Goldsboro 4468261, North Carolina 4482348 27534
Contact:
Site Public Contact
919-587-9084
jfields@cancersmoc.com

Southeastern Medical Oncology Center-Jacksonville
Jacksonville 4473083, North Carolina 4482348 28546
Contact:
Site Public Contact
910-587-9084
jfields@cancersmoc.com

Miami Valley Hospital South
Centerville 4508204, Ohio 5165418 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital
Dayton 4509884, Ohio 5165418 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Dayton 4509884, Ohio 5165418 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital North
Dayton 4509884, Ohio 5165418 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin 4512203, Ohio 5165418 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville 5156493, Ohio 5165418 45331
Contact:
Site Public Contact
937-569-7515

ProMedica Flower Hospital
Sylvania 5173572, Ohio 5165418 43560
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

Upper Valley Medical Center
Troy 5174358, Ohio 5165418 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Cancer Centers of Southwest Oklahoma Research
Lawton 4540737, Oklahoma 4544379 73505
Contact:
Site Public Contact
877-231-4440

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

UPMC Hillman Cancer Center Erie
Erie 5188843, Pennsylvania 6254927 16505
Contact:
Site Public Contact
412-864-7716
ClinicalResearchServices@upmc.edu

UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg 5192029, Pennsylvania 6254927 15601
Contact:
Site Public Contact
724-838-1900

Penn State Milton S Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

UPMC Hillman Cancer Center - Monroeville
Monroeville 5201734, Pennsylvania 6254927 15146
Contact:
Site Public Contact
412-864-7716
ClinicalResearchServices@upmc.edu

University of Pennsylvania/Abramson Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Site Public Contact
215-349-8245
PMCancerResearch@pennmedicine.upenn.edu

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Site Public Contact
412-647-8073

UPMC-Passavant Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15237
Contact:
Site Public Contact
412-367-6454

UPMC-Saint Clair Hospital Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15243
Contact:
Site Public Contact
412-502-3920

UPMC Cancer Center-Washington
Washington 5218069, Pennsylvania 6254927 15301
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Reading Hospital
West Reading 5218867, Pennsylvania 6254927 19611
Contact:
Site Public Contact
610-988-9323

Parkland Memorial Hospital
Dallas 4684888, Texas 4736286 75235
Contact:
Site Public Contact
214-590-5582
canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Dallas 4684888, Texas 4736286 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth 4691930, Texas 4736286 76104
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

UT Southwestern Clinical Center at Richardson/Plano
Richardson 4722625, Texas 4736286 75080
Contact:
Site Public Contact
972-669-7044
Suzanne.cole@utsouthwestern.edu

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109
Contact:
Site Public Contact
800-804-8824

University of Washington Medical Center - Montlake
Seattle 5809844, Washington 5815135 98195
Contact:
Site Public Contact
800-804-8824

West Virginia University Charleston Division
Charleston 4801859, West Virginia 4826850 25304
Contact:
Site Public Contact
304-388-9944

ThedaCare Regional Cancer Center
Appleton 5244080, Wisconsin 5279468 54911
Contact:
Site Public Contact
920-364-3604
ResearchDept@thedacare.org

Aurora Cancer Care-Southern Lakes VLCC
Burlington 5247214, Wisconsin 5279468 53105
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-EC Cancer Center
Eau Claire 5251436, Wisconsin 5279468 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Health Care Germantown Health Center
Germantown 5254218, Wisconsin 5279468 53022
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Grafton
Grafton 5254739, Wisconsin 5279468 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora BayCare Medical Center
Green Bay 5254962, Wisconsin 5279468 54311
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Kenosha South
Kenosha 5258393, Wisconsin 5279468 53142
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Bay Area Medical Group-Marinette
Marinette 5261852, Wisconsin 5279468 54143
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-Marshfield
Marshfield 5261969, Wisconsin 5279468 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Cancer Care-Milwaukee
Milwaukee 5263045, Wisconsin 5279468 53209
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's Medical Center
Milwaukee 5263045, Wisconsin 5279468 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Sinai Medical Center
Milwaukee 5263045, Wisconsin 5279468 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center - Minocqua
Minocqua 5263156, Wisconsin 5279468 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

ProHealth D N Greenwald Center
Mukwonago 5263965, Wisconsin 5279468 53149
Contact:
Site Public Contact
research.institute@phci.org

ProHealth Oconomowoc Memorial Hospital
Oconomowoc 5265499, Wisconsin 5279468 53066
Contact:
Site Public Contact
262-928-7878

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh 5265838, Wisconsin 5279468 54904
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Racine
Racine 5268249, Wisconsin 5279468 53406
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-Rice Lake
Rice Lake 5268798, Wisconsin 5279468 54868
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan 5272893, Wisconsin 5279468 53081
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point 5274644, Wisconsin 5279468 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Medical Center in Summit
Summit, Wisconsin 5279468 53066
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers 5276609, Wisconsin 5279468 54241
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

ProHealth Waukesha Memorial Hospital
Waukesha 5278052, Wisconsin 5279468 53188
Contact:
Site Public Contact
262-928-7632

UW Cancer Center at ProHealth Care
Waukesha 5278052, Wisconsin 5279468 53188
Contact:
Site Public Contact
262-928-5539
Chanda.miller@phci.org

ThedaCare Cancer Care - Waupaca
Waupaca 5278083, Wisconsin 5279468 54981
Contact:
Site Public Contact
920-364-3605
ResearchDept@thedacare.org

Aurora Cancer Care-Milwaukee West
Wauwatosa 5278159, Wisconsin 5279468 53226
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis 5278420, Wisconsin 5279468 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center - Weston
Weston 5278693, Wisconsin 5279468 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], ypT0N0/ 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 (ypt0N0, 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

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.