Recruiting
Phase 2
Phase 3

MEDI4736 with Chemotherapy

Sponsor:

National Cancer Institute (NCI)

Code:

NCT04628767

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Cisplatin

Computed Tomography

Doxorubicin Hydrochloride

Study Details

Brief summary:

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.

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

Study ID

NCT04628767

Start date

Nov 12, 2021

Status verified date

Jul, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 and/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
  • Patients must not have any component of small cell/neuroendocrine carcinoma. Other histologic subtypes (variants) are permitted provided the half or predominant (>= 50%) subtype is conventional urothelial carcinoma
  • Leukocytes >= 3,000/mcL (obtained =< 14 days prior to registration/randomization)
  • Platelets >= 100,000/mcL (obtained =< 14 days prior to registration/randomization)
  • Total bilirubin =< 1.2 mg/dL (or ≤ 2 mg/dL for 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
  • 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 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) scan 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 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 systemic 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 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 therapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible
  • Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration/randomization or any history of inflammatory bowel disease (inflammatory 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 and are allowed:

  • Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment
  • Steroids as pre-medications for hypersensitivity reactions (e.g. computed tomography \[CT\] pre-medication)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration/randomization are eligible for this trial

  • NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be 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 not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab
  • Patient must not have had a major surgical procedure within 28 days prior to registration/randomization

  • NOTE: Cystoscopy/ureteroscopy/TURBT, stent placement or nephrostomy tube is not considered major surgery
  • Patient must not have history of allogenic organ transplantation
  • Patient must have a body weight of > 30 kg
  • Patient must have life expectancy of >= 12 weeks
  • Patient must have creatinine clearance > 15 ml/min as estimated by Cockcroft-Gault formula or glomerular filtration rate (GFR) > 15 ml/min/1.73m\^2 within 28 days prior to registration/randomization

  • NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral 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 > 50ml/min (estimated by Cockcroft-Gault formula) or GFR > 50ml/min/1.73m\^2
  • ECOG performance status 0-1
  • Hearing loss grade 0-2
  • Neuropathy 0-1
  • In addition, the patient must have an absolute neutrophil count (ANC) >= 1,500/mcL obtained =< 14 days prior to randomization
  • Also, the patient must have left ventricular ejection fraction (LVEF) >= 50% by (either multigated acquisition scan \[MUGA\] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization

Study Design

Enrollment

131 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Biopsy Procedure

Undergo tissue biopsy

Biospecimen Collection

Undergo blood sample collection

Cisplatin

Given IV

Computed Tomography

Undergo CT

Doxorubicin Hydrochloride

Given Iv

Durvalumab

Given IV

Gemcitabine Hydrochloride

Given IV

Magnetic Resonance Imaging

Undergo MRI

Methotrexate

Given IV

Pegfilgrastim

Given via injection

Therapeutic Conventional Surgery

Undergo surgery

Vinblastine Sulfate

Given Iv

Primary outcome measure

  • Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B) [ Time Frame: From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years ]
  • Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C) [ Time Frame: At surgery ]

Central Contacts and Locations

Locations

Kingman Regional Medical Center

Recruiting

Kingman, Arizona, United States, 86401

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

John A. Ellerton

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Site Public Contact

800-826-4673becomingapatient@coh.org

Principal Investigator:

Abhishek Tripathi

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Site Public Contact

858-822-5354cancercto@ucsd.edu

Principal Investigator:

Aditya Bagrodia

Stanford Cancer Institute Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Site Public Contact

650-498-7061cancertrialsinfo@stanford.edu

Principal Investigator:

Ali R. Khaki

UC San Diego Medical Center - Hillcrest

Recruiting

San Diego, California, United States, 92103

Contacts

Site Public Contact

rhabbaba@health.ucsd.edu

Principal Investigator:

Aditya Bagrodia

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Elizabeth R. Kessler

Poudre Valley Hospital

Recruiting

Fort Collins, Colorado, United States, 80524

Contacts

Site Public Contact

970-297-6150

Principal Investigator:

Elizabeth R. Kessler

Cancer Care and Hematology-Fort Collins

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

Site Public Contact

ecog.rss@jimmy.harvard.edu

Principal Investigator:

Elizabeth R. Kessler

UCHealth Greeley Hospital

Recruiting

Greeley, Colorado, United States, 80631

Contacts

Site Public Contact

ecog.rss@jimmy.harvard.edu

Principal Investigator:

Elizabeth R. Kessler

UCHealth Highlands Ranch Hospital

Recruiting

Highlands Ranch, Colorado, United States, 80129

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Elizabeth R. Kessler

UCHealth Lone Tree Health Center

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Site Public Contact

ecog.rss@jimmy.harvard.edu

Principal Investigator:

Elizabeth R. Kessler

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Site Public Contact

970-203-7083

Principal Investigator:

Elizabeth R. Kessler

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Site Public Contact

202-877-8839

Principal Investigator:

Suthee Rapisuwon

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Site Public Contact

202-243-2373jquiver1@jhmi.edu

Principal Investigator:

Jean H. Hoffman-Censits

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Jacqueline T. Brown

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Jacqueline T. Brown

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Jacqueline T. Brown

Emory Decatur Hospital

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Site Public Contact

440-778-1868clinicaltrialsoncology@dekalbmedical.org

Principal Investigator:

Jacqueline T. Brown

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

Elie G. Dib

Advocate Good Shepherd Hospital

Recruiting

Barrington, Illinois, United States, 60010

Contacts

Site Public Contact

847-842-4847

Principal Investigator:

Thomas J. Saphner

SIH Cancer Institute

Recruiting

Carterville, Illinois, United States, 62918

Contacts

Site Public Contact

618-985-3333clinical.research@sih.net

Principal Investigator:

Bryan A. Faller

Advocate Illinois Masonic Medical Center

Recruiting

Chicago, Illinois, United States, 60657

Contacts

Site Public Contact

773-296-5360

Principal Investigator:

Thomas J. Saphner

AMG Crystal Lake - Oncology

Recruiting

Crystal Lake, Illinois, United States, 60014

Contacts

Site Public Contact

630-929-6129advocateresearch@advocate.com

Principal Investigator:

Thomas J. Saphner

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Prem Sobti

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Advocate Good Samaritan Hospital

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Site Public Contact

630-275-1270Barbara.barhamand@advocatehealth.com

Principal Investigator:

Thomas J. Saphner

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Prem Sobti

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Advocate Sherman Hospital

Recruiting

Elgin, Illinois, United States, 60123

Contacts

Site Public Contact

847-429-2907

Principal Investigator:

Thomas J. Saphner

Advocate South Suburban Hospital

Recruiting

Hazel Crest, Illinois, United States, 60429

Contacts

Site Public Contact

708-799-9995

Principal Investigator:

Thomas J. Saphner

AMG Libertyville - Oncology

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

Site Public Contact

630-929-6129advocateresearch@advocatehealth.com

Principal Investigator:

Thomas J. Saphner

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Prem Sobti

SSM Health Good Samaritan

Recruiting

Mount Vernon, Illinois, United States, 62864

Contacts

Site Public Contact

618-899-1894gayla.hall@ssmhealth.com

Principal Investigator:

Jay W. Carlson

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Advocate Christ Medical Center

Recruiting

Oak Lawn, Illinois, United States, 60453-2699

Contacts

Site Public Contact

800-323-8622

Principal Investigator:

Thomas J. Saphner

Advocate Lutheran General Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Site Public Contact

847-384-3621

Principal Investigator:

Thomas J. Saphner

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Prem Sobti

University of Iowa Healthcare Cancer Services Quad Cities

Recruiting

Bettendorf, Iowa, United States, 52722

Contacts

Site Public Contact

563-355-7733katherine-daprile@uiowa.edu

Principal Investigator:

Fernando Maciel Barbosa

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Fernando Maciel Barbosa

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Patrick J. Hensley

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Site Public Contact

225-215-1353clinicalresearch@marybird.com

Principal Investigator:

Victor T. Lin

Mary Bird Perkins Cancer Center - Metairie

Recruiting

Metairie, Louisiana, United States, 70002

Contacts

Site Public Contact

504-584-6990

Principal Investigator:

Victor T. Lin

East Jefferson General Hospital

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Rajasree P. Chowdry

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Rajasree P. Chowdry

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Rajasree P. Chowdry

Harold Alfond Center for Cancer Care

Recruiting

Augusta, Maine, United States, 04330

Contacts

Site Public Contact

207-626-4855

Principal Investigator:

Erin Adler

MaineHealth Cancer Care and IV Therapy - Sanford

Recruiting

Sanford, Maine, United States, 04073

Contacts

Site Public Contact

207-396-8670clinicalresearch@mainehealth.org

Principal Investigator:

Erin Adler

MaineHealth Cancer Care Center of York County

Recruiting

Sanford, Maine, United States, 04073

Contacts

Site Public Contact

207-459-1600

Principal Investigator:

Erin Adler

MaineHealth Maine Medical Center- Scarborough

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Site Public Contact

207-396-8670clinicalresearch@mainehealth.org

Principal Investigator:

Erin Adler

MaineHealth Cancer Care and IV Therapy - South Portland

Recruiting

South Portland, Maine, United States, 04106

Contacts

Site Public Contact

207-396-8670clinicalresearch@mainehealth.org

Principal Investigator:

Erin Adler

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Site Public Contact

410-955-8804jhcccro@jhmi.edu

Principal Investigator:

Jean H. Hoffman-Censits

UMass Memorial Medical Center - University Campus

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Site Public Contact

508-856-3216cancer.research@umassmed.edu

Principal Investigator:

Kriti Mittal

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Hematology Oncology Consultants-Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Elie G. Dib

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Elie G. Dib

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Elie G. Dib

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Henry Ford Saint John Hospital - Macomb Medical

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Elie G. Dib

Michigan Healthcare Professionals Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

248-858-6215Emily.Crofts@trinity-health.org

Principal Investigator:

Elie G. Dib

Newland Medical Associates-Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

MyMichigan Medical Center Saginaw

Recruiting

Saginaw, Michigan, United States, 48601

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

MyMichigan Medical Center Tawas

Recruiting

Tawas City, Michigan, United States, 48764

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Huron Gastroenterology PC

Recruiting

Ypsilanti, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Maplewood

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Lance C. Pagliaro

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Lakeview Hospital

Recruiting

Stillwater, Minnesota, United States, 55082

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Parkland Health Center - Farmington

Recruiting

Farmington, Missouri, United States, 63640

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Sainte Genevieve County Memorial Hospital

Recruiting

Sainte Genevieve, Missouri, United States, 63670

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Site Public Contact

314-525-6042Danielle.Werle@mercy.net

Principal Investigator:

Jay W. Carlson

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Missouri Baptist Sullivan Hospital

Recruiting

Sullivan, Missouri, United States, 63080

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

OptumCare Cancer Care at Charleston

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

John A. Ellerton

OptumCare Cancer Care at Fort Apache

Recruiting

Las Vegas, Nevada, United States, 89183

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

John A. Ellerton

Cooperman Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Site Public Contact

973-322-5200

Principal Investigator:

Saum B. Ghodoussipour

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-7356

Principal Investigator:

Saum B. Ghodoussipour

Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Site Public Contact

732-557-8294Lennette.Gonzales@rwjbh.org

Principal Investigator:

Saum B. Ghodoussipour

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-925-0348HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Amy C. Tarnower

Southeastern Medical Oncology Center-Clinton

Recruiting

Clinton, North Carolina, United States, 28328

Contacts

Site Public Contact

919-587-9084jfields@cancersmoc.com

Principal Investigator:

Samer S. Kasbari

Southeastern Medical Oncology Center-Goldsboro

Recruiting

Goldsboro, North Carolina, United States, 27534

Contacts

Site Public Contact

919-587-9084jfields@cancersmoc.com

Principal Investigator:

Samer S. Kasbari

Southeastern Medical Oncology Center-Jacksonville

Recruiting

Jacksonville, North Carolina, United States, 28546

Contacts

Site Public Contact

910-587-9084jfields@cancersmoc.com

Principal Investigator:

Samer S. Kasbari

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Premier Blood and Cancer Center

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Site Public Contact

937-276-8320

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital North

Recruiting

Dayton, Ohio, United States, 45415

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Atrium Medical Center-Middletown Regional Hospital

Recruiting

Franklin, Ohio, United States, 45005-1066

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Miami Valley Cancer Care and Infusion

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Site Public Contact

937-569-7515

Principal Investigator:

Tarek M. Sabagh

ProMedica Flower Hospital

Recruiting

Sylvania, Ohio, United States, 43560

Contacts

Site Public Contact

419-824-1842PCIOncResearch@promedica.org

Principal Investigator:

Jeffrey H. Muler

Upper Valley Medical Center

Recruiting

Troy, Ohio, United States, 45373

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Cancer Centers of Southwest Oklahoma Research

Recruiting

Lawton, Oklahoma, United States, 73505

Contacts

Site Public Contact

877-231-4440

Principal Investigator:

Adanma Anji Ayanambakkam Attanathi

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Adanma Anji Ayanambakkam Attanathi

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Leonard J. Appleman

UPMC Cancer Centers - Arnold Palmer Pavilion

Recruiting

Greensburg, Pennsylvania, United States, 15601

Contacts

Site Public Contact

724-838-1900

Principal Investigator:

Leonard J. Appleman

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Site Public Contact

717-531-3779CTO@hmc.psu.edu

Principal Investigator:

Monika Joshi

UPMC Hillman Cancer Center - Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Leonard J. Appleman

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

215-349-8245PMCancerResearch@pennmedicine.upenn.edu

Principal Investigator:

Ronac Mamtani

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

William J. Tester

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Leonard J. Appleman

UPMC-Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Site Public Contact

412-367-6454

Principal Investigator:

Leonard J. Appleman

UPMC-Saint Clair Hospital Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Contacts

Site Public Contact

412-502-3920

Principal Investigator:

Leonard J. Appleman

UPMC Cancer Center-Washington

Recruiting

Washington, Pennsylvania, United States, 15301

Contacts

Site Public Contact

ecog.rss@jimmy.harvard.edu

Principal Investigator:

Leonard J. Appleman

Reading Hospital

Recruiting

West Reading, Pennsylvania, United States, 19611

Contacts

Site Public Contact

610-988-9323

Principal Investigator:

Terrence P. Cescon

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Site Public Contact

214-590-5582canceranswerline@UTSouthwestern.edu

Principal Investigator:

Vitaly Margulis

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Vitaly Margulis

UT Southwestern/Simmons Cancer Center-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Vitaly Margulis

UT Southwestern Clinical Center at Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Contacts

Site Public Contact

972-669-7044Suzanne.cole@utsouthwestern.edu

Principal Investigator:

Vitaly Margulis

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Petros Grivas

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Petros Grivas

West Virginia University Charleston Division

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Site Public Contact

304-388-9944

Principal Investigator:

Kok Hoe Chan

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Site Public Contact

920-364-3604ResearchDept@thedacare.org

Principal Investigator:

Matthias Weiss

Aurora Cancer Care-Southern Lakes VLCC

Recruiting

Burlington, Wisconsin, United States, 53105

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

Aurora Health Care Germantown Health Center

Recruiting

Germantown, Wisconsin, United States, 53022

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Aurora Cancer Care-Grafton

Recruiting

Grafton, Wisconsin, United States, 53024

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Aurora BayCare Medical Center

Recruiting

Green Bay, Wisconsin, United States, 54311

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Aurora Cancer Care-Kenosha South

Recruiting

Kenosha, Wisconsin, United States, 53142

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Aurora Bay Area Medical Group-Marinette

Recruiting

Marinette, Wisconsin, United States, 54143

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

Aurora Cancer Care-Milwaukee

Recruiting

Milwaukee, Wisconsin, United States, 53209

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Aurora Saint Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Aurora Sinai Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

ProHealth D N Greenwald Center

Recruiting

Mukwonago, Wisconsin, United States, 53149

Contacts

Site Public Contact

research.institute@phci.org

Principal Investigator:

Timothy R. Wassenaar

ProHealth Oconomowoc Memorial Hospital

Recruiting

Oconomowoc, Wisconsin, United States, 53066

Contacts

Site Public Contact

262-928-7878

Principal Investigator:

Timothy R. Wassenaar

Vince Lombardi Cancer Clinic - Oshkosh

Recruiting

Oshkosh, Wisconsin, United States, 54904

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Aurora Cancer Care-Racine

Recruiting

Racine, Wisconsin, United States, 53406

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

Vince Lombardi Cancer Clinic-Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

Aurora Medical Center in Summit

Recruiting

Summit, Wisconsin, United States, 53066

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Vince Lombardi Cancer Clinic-Two Rivers

Recruiting

Two Rivers, Wisconsin, United States, 54241

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

ProHealth Waukesha Memorial Hospital

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Site Public Contact

262-928-7632

Principal Investigator:

Timothy R. Wassenaar

UW Cancer Center at ProHealth Care

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Site Public Contact

262-928-5539Chanda.miller@phci.org

Principal Investigator:

Timothy R. Wassenaar

ThedaCare Cancer Care - Waupaca

Recruiting

Waupaca, Wisconsin, United States, 54981

Contacts

Site Public Contact

920-364-3605ResearchDept@thedacare.org

Principal Investigator:

Matthias Weiss

Aurora Cancer Care-Milwaukee West

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Aurora West Allis Medical Center

Recruiting

West Allis, Wisconsin, United States, 53227

Contacts

Site Public Contact

414-302-2304ncorp@aurora.org

Principal Investigator:

Thomas J. Saphner

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-03.