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Brief Title: MEDI4736 (Durvalumab) and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

A Phase II/III Trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

INTRODUCTION

  • Org Study ID: NCI-2020-09850
  • Secondary ID: NCI-2020-09850, EA8192, EA8192, U10CA180820
  • NTC ID: NCT04628767
  • Sponsor: National Cancer Institute (NCI)

BRIEF SUMMARY

This phase 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.

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 MEDI4736 (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 separately. (All patients) V. To evaluate cancer-specific survival of patients in each arm separately. (All patients) VI. To evaluate renal function outcomes following systemic treatment and following surgery ([RNU) in each arm separately. (All patients) VII. To evaluate safety and tolerability of neoadjuvant aMVAC alone or in combination with MEDI4736 (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.

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.

  • Overall Status
    Recruiting
  • Start Date
    May 6, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)

Primary Outcome 1 - Timeframe: From randomization to the earliest of systemic recurrence, disease progression, or death from any cause, assessed up to 5 years

Primary Outcome 2 - Measure: Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C)

Primary Outcome 2 - Timeframe: At surgery

CONDITION

  • Renal Pelvis and Ureter Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
STEP 1 REGISTRATION AND RANDOMIZATION

- 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 60 days prior to registration 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) - Platelets >= 100,000/mcL (obtained =< 14 days prior to registration) - 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) - 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)
Hemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration)
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 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
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 a life expectancy of >= 12 weeks
Patient must have a creatinine clearance > 15 ml/min as by Crockroft-Gault or 24-hour creatinine clearance within 28 days prior to registration
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 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 the following criteria will be assigned to the cisplatin-ineligible Arm C:
Creatinine clearance of > 15 ml/min and =< 50 ml/min - 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 cisplatin-eligible Arm A or Arm B:
Patient must have an absolute neutrophil count (ANC) >= 1,500/mcL obtained =< 14 days prior to randomization - Patient must have ECOG performance status 0-1 - Patient must have left ventricular ejection fraction (LVEF) >= 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within 28 days prior to randomization

- Patient must not have peripheral neuropathy >= grade 2 or hearing loss >= grade 3
Exclusion Criteria:
Patients must not have any component of small cell 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 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
Patient must have no evidence of metastatic disease or clinically enlarged lymph nodes (>= 1.0 cm short axis) on imaging required within 28 days prior to registration (solitary slightly enlarged lymph node with negative biopsy is allowed)
NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness should also undergo baseline bone scans to evaluate for bone metastasis
Patient must not have another active (or within 2 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 surveillance 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 - 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 3 months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, 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 an active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration or a history of inflammatory bowel disease (inflammatory bowel disease [IBD], colitis, or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome or immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diverticulosis, 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 MEDI4736 (MEDI4736 (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 a concomitant primary urothelial carcinoma of the bladder and/or urethra
NOTE: 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
Patient must not have prior history of muscle-invasive urothelial carcinoma with or without systemic chemotherapy (T2-4a and/or N1) within 2 years prior to registration
NOTE: Patients who have no evidence of disease (NED) for more than 2 years from the latest therapy (surgery, radiation, chemotherapy, or clinical trial) are eligible

- Patient must not have received live attenuated vaccine within 30 days prior to the first dose of MEDI4736 (durvalumab), while on protocol treatment and within 30 days after the last dose of MEDI4736 (durvalumab)

- Patient must not have had a major surgical procedure (as defined by the Investigator) within 28 days prior to registration

- Patient must not have a history of allogenic organ transplantation

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jean H Hoffman-Censits

Role: Principal Investigator

Affiliation: ECOG-ACRIN Cancer Research Group

Overall Contact

Name: Jean H Hoffman-Censits

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United States
Status: Recruiting Contact: Principal Investigator
Ahmet Murat Aydin
415-209-2683
hempell@sutterhealth.org
Facility: Sutter Auburn Faith Hospital
Auburn, California 95602
United States
Status: Recruiting Contact: Contact
Site Public Contact
415-209-2683
hempell@sutterhealth.org
Facility: Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
United States
Status: Recruiting Contact: Principal Investigator
Ari D. Baron
415-209-2683
hempell@sutterhealth.org
Facility: Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
United States
Status: Recruiting Contact: Contact
Site Public Contact
415-209-2683
hempell@sutterhealth.org
Facility: Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
United States
Status: Recruiting Contact: Principal Investigator
Ari D. Baron
415-209-2683
hempell@sutterhealth.org
Facility: Sutter Roseville Medical Center
Roseville, California 95661
United States
Status: Recruiting Contact: Contact
Site Public Contact
415-209-2683
hempell@sutterhealth.org
Facility: Sutter Medical Center Sacramento
Sacramento, California 95816
United States
Status: Recruiting Contact: Principal Investigator
Ari D. Baron
415-209-2683
hempell@sutterhealth.org
Facility: California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
United States
Status: Recruiting Contact: Contact
Site Public Contact
415-209-2683
hempell@sutterhealth.org
Facility: Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
United States
Status: Recruiting Contact: Principal Investigator
Ari D. Baron
415-209-2683
ecog.rss@jimmy.harvard.edu
Facility: Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
United States
Status: Recruiting Contact: Contact
Site Public Contact
720-848-0650
ecog.rss@jimmy.harvard.edu
Facility: University of Colorado Hospital
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Principal Investigator
Ari D. Baron
970-297-6150
advocateresearch@advocate.com
Facility: Poudre Valley Hospital
Fort Collins, Colorado 80524
United States
Status: Recruiting Contact: Contact
Site Public Contact
720-848-0650
Research@carle.com
Facility: Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
United States
Status: Recruiting Contact: Principal Investigator
Ari D. Baron
970-203-7083
morganthaler.jodi@mhsil.com
Facility: UCHealth Greeley Hospital
Greeley, Colorado 80631
United States
Status: Recruiting Contact: Contact
Site Public Contact
202-877-8839
Barbara.barhamand@advocatehealth.com
Facility: UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
United States
Status: Recruiting Contact: Principal Investigator
Ari D. Baron
847-842-4847
Research@carle.com
Facility: Medical Center of the Rockies
Loveland, Colorado 80538
United States
Status: Recruiting Contact: Contact
Site Public Contact
773-296-5360
morganthaler.jodi@mhsil.com
Facility: MedStar Washington Hospital Center
Washington, District of Columbia 20010
United States
Status: Recruiting Contact: Principal Investigator
Ari D. Baron
630-929-6129
advocateresearch@advocatehealth.com
Facility: Advocate Good Shepherd Hospital
Barrington, Illinois 60010
United States
Status: Recruiting Contact: Contact
Site Public Contact
630-275-1270
Research@carle.com
Facility: Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-323-8622
ClinicalResearch@mmc.org
Facility: AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
United States
Status: Recruiting Contact: Principal Investigator
Elizabeth R. Kessler
847-384-3621
jhcccro@jhmi.edu
Facility: Carle on Vermilion
Danville, Illinois 61832
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-545-7929
cancer.research@umassmed.edu
Facility: Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Principal Investigator
Elizabeth R. Kessler
800-444-7541
MCRCwebsitecontactform@stjoeshealth.org
Facility: Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132
MCRCwebsitecontactform@stjoeshealth.org
Facility: Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar
515-239-4734
MCRCwebsitecontactform@stjoeshealth.org
Facility: Crossroads Cancer Center
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Contact
Site Public Contact
563-355-7733
MCRCwebsitecontactform@stjoeshealth.org
Facility: Advocate Sherman Hospital
Elgin, Illinois 60123
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar
515-956-4132
MCRCwebsitecontactform@stjoeshealth.org
Facility: Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
United States
Status: Recruiting Contact: Principal Investigator
Prem Sobti
515-956-4132
MCRCwebsitecontactform@stjoeshealth.org
Facility: AMG Libertyville - Oncology
Libertyville, Illinois 60048
United States
Status: Recruiting Contact: Contact
Site Public Contact
207-626-4855
mmcorc@healthpartners.com
Facility: Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Status: Recruiting Contact: Contact
Site Public Contact
410-955-8804
sfmc@sfmc.net
Facility: Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
jfields@cancersmoc.com
Facility: Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar
734-712-7251
clinical.trials@daytonncorp.org
Facility: Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar
734-712-7251
clinical.trials@daytonncorp.org
Facility: Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
ou-clinical-trials@ouhsc.edu
Facility: Springfield Clinic
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar
952-993-1517
ONCTrialNow@jefferson.edu
Facility: Carle Cancer Center
Urbana, Illinois 61801
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar
952-993-1517
canceranswerline@UTSouthwestern.edu
Facility: Reid Health
Richmond, Indiana 47374
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
314-251-7066
Suzanne.cole@utsouthwestern.edu
Facility: Mary Greeley Medical Center
Ames, Iowa 50010
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-767-9355
ResearchDept@thedacare.org
Facility: McFarland Clinic PC - Ames
Ames, Iowa 50010
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
919-587-9084
ncorp@aurora.org
Facility: University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa 52722
United States
Status: Recruiting Contact: Contact
Site Public Contact
919-587-9084
ncorp@aurora.org
Facility: McFarland Clinic PC-Boone
Boone, Iowa 50036
United States
Status: Recruiting Contact: Principal Investigator
Prem Sobti
910-587-9084
ncorp@aurora.org
Facility: McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa 50501
United States
Status: Recruiting Contact: Contact
Site Public Contact
336-713-6771
ncorp@aurora.org
Facility: University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross
937-528-2900
ncorp@aurora.org
Facility: McFarland Clinic PC-Jefferson
Jefferson, Iowa 50129
United States
Status: Recruiting Contact: Contact
Site Public Contact
937-528-2900
ncorp@aurora.org
Facility: McFarland Clinic PC-Marshalltown
Marshalltown, Iowa 50158
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
937-528-2900
oncology.clinical.trials@marshfieldresearch.org
Facility: East Jefferson General Hospital
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Contact
Site Public Contact
937-528-2900
ncorp@aurora.org
Facility: LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Principal Investigator
Yousef Zakharia
937-528-2900
oncology.clinical.trials@marshfieldresearch.org
Facility: Harold Alfond Center for Cancer Care
Augusta, Maine 04330
United States
Status: Recruiting Contact: Contact
Site Public Contact
937-528-2900
research.institute@phci.org
Facility: MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine 04005
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
937-528-2900
ncorp@aurora.org
Facility: MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine 04073
United States
Status: Recruiting Contact: Contact
Site Public Contact
877-231-4440
ncorp@aurora.org
Facility: Maine Medical Partners - South Portland
South Portland, Maine 04106
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
405-271-8777
oncology.clinical.trials@marshfieldresearch.org
Facility: Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: Contact
Site Public Contact
215-600-9151
ncorp@aurora.org
Facility: UMass Memorial Medical Center - University Campus
Worcester, Massachusetts 01655
United States
Status: Recruiting Contact: Principal Investigator
Yousef Zakharia
843-792-9321
oncology.clinical.trials@marshfieldresearch.org
Facility: Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Status: Recruiting Contact: Contact
Site Public Contact
214-648-7097
ncorp@aurora.org
Facility: Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
214-648-7097
ncorp@aurora.org
Facility: Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Contact
Site Public Contact
972-669-7044
Chanda.miller@phci.org
Facility: Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
800-804-8824
ncorp@aurora.org
Facility: Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-804-8824
ncorp@aurora.org
Facility: Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Principal Investigator
Scott E. Delacroix
800-804-8824
oncology.clinical.trials@marshfieldresearch.org
Facility: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Contact
Site Public Contact
920-364-3605
Facility: Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
414-302-2304
Facility: Genesee Hematology Oncology PC
Flint, Michigan 48503
United States
Status: Recruiting Contact: Principal Investigator
Rachit Kumar
414-302-2304
Facility: Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
414-302-2304
Facility: Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Contact
Site Public Contact
414-302-2304
Facility: Huron Gastroenterology PC
Ypsilanti, Michigan 48106
United States
Status: Recruiting Contact: Contact
Site Public Contact
414-302-2304
Facility: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Principal Investigator
Rachit Kumar
414-302-2304
Facility: Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
United States
Status: Recruiting Contact: Principal Investigator
Elie G. Dib
800-782-8581
Facility: Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Regions Hospital
Saint Paul, Minnesota 55101
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
United States
Status: Recruiting Contact: Principal Investigator
Michael McCormack

Facility: Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

Facility: Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
United States
Status: Recruiting Contact: Principal Investigator
Tarek M. Sabagh

Facility: Miami Valley Hospital South
Centerville, Ohio 45459
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Miami Valley Hospital
Dayton, Ohio 45409
United States
Status: Recruiting Contact: Principal Investigator
Tarek M. Sabagh

Facility: Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Miami Valley Hospital North
Dayton, Ohio 45415
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

Facility: Armes Family Cancer Center
Findlay, Ohio 45840
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
United States
Status: Recruiting Contact: Principal Investigator
Tarek M. Sabagh

Facility: Greater Dayton Cancer Center
Kettering, Ohio 45409
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Kettering Medical Center
Kettering, Ohio 45429
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

Facility: Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Medical University of South Carolina
Charleston, South Carolina 29425
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

Facility: UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
United States
Status: Recruiting Contact: Principal Investigator
Adanma Anji Ayanambakkam Attanathi

Facility: UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: FHCC South Lake Union
Seattle, Washington 98109
United States
Status: Recruiting Contact: Principal Investigator
Adanma Anji Ayanambakkam Attanathi

Facility: Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Status: Recruiting Contact: Principal Investigator
William J. Tester

Facility: ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
United States
Status: Recruiting Contact: Principal Investigator
Theodore S. Gourdin

Facility: Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
United States
Status: Recruiting Contact: Principal Investigator
Vitaly Margulis

Facility: Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
United States
Status: Recruiting Contact: Principal Investigator
Vitaly Margulis

Facility: Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Status: Recruiting Contact: Principal Investigator
Vitaly Margulis

Facility: Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
United States
Status: Recruiting Contact: Principal Investigator
Petros Grivas

Facility: Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
United States
Status: Recruiting Contact: Principal Investigator
Petros Grivas

Facility: ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
United States
Status: Recruiting Contact: Principal Investigator
Harsha V. Poola

Facility: Aurora Cancer Care-Racine
Racine, Wisconsin 53406
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar

Facility: Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar

Facility: Aurora Medical Center in Summit
Summit, Wisconsin 53066
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar

Facility: ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar

Facility: Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Aurora West Allis Medical Center
West Allis, Wisconsin 53227
United States
Status: Recruiting Contact: Principal Investigator
Rubina Qamar

Facility: Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States
Status: Recruiting Contact: Contact
Site Public Contact