AzTrials
AzTrials

Bladder AdenocarcinomaPhase 2NCT03866382

Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

A Phase 2 study testing Biospecimen Collection, Bone Scan and Cabozantinib S-malate in people with Bladder Adenocarcinoma and Bladder Clear Cell Adenocarcinoma, run by National Cancer Institute (NCI) at 581 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Bone Scan and Cabozantinib S-malate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
581 sitesin 2 countries
Study dates
13 May 2019to 28 Feb 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:
  • One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
  • One bone lesion on bone scan (tec99 or sodium fluoride [NaF] PET/CT, CT or MRI) for the bone-only cohort.
  • Histologically confirmed diagnosis of one of the following metastatic cohorts:
  • Small cell/ neuroendocrine carcinoma of the bladder (Cohort A)- All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded
  • Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization [WHO] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma
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  • Squamous cell carcinoma of the bladder (Cohort C) - must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma)
  • Plasmacytoid urothelial carcinoma (Cohort D) - Tumor should show predominantly > or equal ~ 50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and/or rhabdoid features as well)
  • Any penile cancer (Cohort E)
  • Sarcomatoid renal cell carcinoma (Cohort F) - Tumor should be predominantly sarcomatoid ~ 50% (including rhabdoid differentiation) is also unclassified renal cell carcinomas (RCCs): all (assuming they are high grade with metastasis) malignant angiomyolipomas are allowed
  • Other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to (Cohort G) : Micropapillary (Tumor should show predominantly > or equal 50% micropapillary architecture), giant cell, lipid-rich, clear cell and nested variants (Tumor should predominantly > or equal 50% show these features), large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer (Only treatment-naïve primary small cell of prostate with any amount of small cell component allowed. Post-treatment small cell prostatic carcinomas are not allowed), Malignant testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC
  • Note: Translocation positive renal cell carcinoma patients are eligible. However, AREN1721 should be considered before this trial
  • Sarcomatoid urothelial carcinoma (Cohort H) - Tumor should show predominantly ~ 50% sarcomatoid differentiation
  • Renal medullary carcinoma (Cohort I) - Per World Health Organization (WHO) definition, ideally confirmed with immunostains
  • Bone-only metastatic GU tumors (non-prostate) (Cohort J) - All genitourinary histologies, except prostate are eligible
  • Renal Collecting Duct Carcinoma (Cohort K) - Per WHO definition (medullary involvement, predominant tubular morphology, desmoplastic stromal reaction, high grade cytology, infiltrative growth pattern, and absence of other renal cell carcinoma subtype or urothelial carcinoma)
  • Urethra carcinoma (Cohort L) - May be of any histology but if urothelial carcinoma then must be isolated to the urethra and not have metachronous or synchronous urothelial carcinoma of the bladder
  • H\&E slides from diagnostic tumor tissue for retrospective central pathology review
  • Patients may have received up to 2 systemic anti-cancer treatments or be treatment naive. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment). Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin-eligible)
  • Age >= 18 years
  • Patients must be able to swallow oral formulation of the tablets
  • Karnofsky performance status >= 80%
  • Absolute neutrophil count (ANC) >= 1,000/mcL
  • Platelet count >= 75,000/mcL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN). For subjects with known Gilbert's disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dL
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal (ULN) (or =< 5 x ULN for patients with liver metastases or Gilbert's disease)
  • Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 40 mL/min/1.73 m^2 (calculated using the Chronic Kidney Disease Epidemiology [CKD-EPI] equation or Cockcroft-Gault formula) for patients with creatinine levels above institutional normal
  • Hemoglobin >= 9 g/dL (transfusion of packed red blood cells [PRBCs] allowed)
  • Serum albumin >= 3.2 g/dL
  • Lipase and amylase =< 2.0 x ULN and no radiologic (on baseline anatomical imaging) or clinical evidence of pancreatitis
  • Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1/PD-L1/CTLA-4 (sequentially or in combination) are also not allowed
  • No prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA-4/CTLA-4 inhibitors with the exception of patients with "urothelial carcinoma" histology (cohorts D, H, J, L)
  • Human immunodeficiency virus (HIV)-positive patients are eligible if on stable dose of highly active antiretroviral therapy (HAART), no clinically significant drug-drug interactions are anticipated with the current HAART regimen, CD4 counts are greater than 350 and viral load is undetectable
  • Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication only and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies etc. are eligible but should be considered for rheumatologic evaluation for the presence of target organ involvement and potential need for systemic treatment
  • Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones or medications (e.g. thyroiditis managed with propylthiouracil [PTU] or methimazole) including physiologic oral corticosteroids are eligible
  • Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, and gastrointestinal (GI) obstruction, within 12 months are not eligible
  • Women of childbearing potential must have a negative pregnancy test =< 7 days prior to registration
  • Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea >= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason
  • Pregnant women may not participate in this study because with cabozantinib, nivolumab, and ipilimumab have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cabozantinib, nivolumab, and ipilimumab, breastfeeding should be discontinued if the mother is treated with these agents
  • The patient has received no cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks before the first dose of study treatment
  • The patient has received no radiation therapy:
  • To the lungs and mediastinum or abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy
  • To brain metastasis within 3 weeks for whole-brain radiotherapy (WBXRT), and 2 weeks for stereotactic body radiation therapy (SBRT) before the first dose of study treatment
  • To the abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy
  • To any other site(s) within 2 weeks before the first dose of study treatment
  • The patient has received no radionuclide treatment within 6 weeks of the first dose of study treatment
  • The patient has received no prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment
  • The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate
  • The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment
  • The patient must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia, neuropathy and other non-clinically significant adverse events (AEs) defined as lab elevation with no associated symptoms or sequelae
  • The patient may not have active brain metastases or epidural disease. Patients with brain metastases previously treated with whole brain radiation or radiosurgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility
  • No concomitant treatment with warfarin. Aspirin (up to 325 mg/day), thrombin or factor Xa inhibitors, low-dose warfarin (=< 1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted
  • No chronic concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort) or strong CYP3A4 inhibitors
  • Because the lists of these agents are constantly changing, it is important to regularly consult medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
  • The patient has not experienced any of the following:
  • Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
  • Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood per day within 1 months before the first dose of study treatment
  • Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
  • The patient has no tumor invading any major blood vessels
  • The patient has no evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib. Patients with rectal tumor masses are not eligible
  • The patient has no uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders including:
  • Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening.
  • Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
  • The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization. Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
  • Any history of congenital long QT syndrome
  • Any of the following within 6 months before registration of study treatment:
  • Unstable angina pectoris
  • Clinically-significant cardiac arrhythmias (patients with atrial fibrillation are eligible)
  • Stroke (including transient ischemic attack [TIA], or other ischemic event)
  • Myocardial infarction
  • Cardiomyopathy
  • No significant gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
  • Any of the following that have not resolved within 28 days before the first dose of study treatment:
  • Active peptic ulcer disease
  • Acute diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or malabsorption syndrome
  • None of the following within 2 years before the first dose of study treatment:
  • Abdominal fistula or genitourinary fistula
  • Gastrointestinal perforation
  • Bowel obstruction or gastric outlet obstruction
  • Intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 2 years before the first dose of study treatment
  • Disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement are not eligible
  • No other clinically significant disorders such as:
  • Severe active infection requiring IV systemic treatment within 14 days before the first dose of study treatment
  • Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
  • History of organ or allogeneic stem cell transplant
  • Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated thyroid-stimulating hormone [TSH], thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment)
  • No history of major surgery as follows:
  • Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post-surgery
  • Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and mediport placement
  • Complete wound healing from prior surgery must be confirmed before the first dose of cabozantinib irrespective of the time from surgery
  • No history of severe hypersensitivity reaction to any monoclonal antibody
  • No evidence of active malignancy, requiring systemic treatment within 2 years of registration
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, nivolumab, ipilimumab or other agents used in study
  • No positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. If HBV sAG is positive, subsequent ribonucleic acid (RNA) polymerase chain reaction (PCR) must be negative
  • No patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include, but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease

Who cannot join

None listed.

Trial locations and contacts

581 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

301 sites in 2 countries

United States300 sites, 104 recruiting

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Suspended

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

    Suspended

  • University Cancer Specialists - Alcoa

    Alcoa, Tennessee, 37701

    Active, not recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Suspended

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com

    Joseph J. Merchant

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Suspended

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

    Suspended

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Suspended

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Suspended

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Suspended

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Suspended

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Suspended

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Suspended

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

    Active, not recruiting

  • PCR Oncology

    Arroyo Grande, California, 93420

    Suspended

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Suspended

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Mehmet A. Bilen

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Mehmet A. Bilen

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Suspended

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Suspended

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Active, not recruiting

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

    Suspended

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Suspended

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Suspended

  • CommonSpirit Saint Joseph Hospital - Bardstown

    Bardstown, Kentucky, 40004

    Active, not recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Samuel A. Funt

    Recruiting

  • Hematology/Oncology Clinic PLLC

    Baton Rouge, Louisiana, 70809

    Suspended

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Victor T. Lin

    Recruiting

  • Ochsner High Grove

    Baton Rouge, Louisiana, 70836

    Active, not recruiting

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

    Suspended

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Benjamin A. Teply

    Recruiting

  • Overlake Medical Center

    Bellevue, Washington, 98004

    Suspended

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Suspended

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Saint Charles Health System

    Bend, Oregon, 97701

    Suspended

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

    Site Public Contact, 800-411-1222

    Andrea B. Apolo

    Recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

    Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu

    Fernando Maciel Barbosa

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Suspended

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Suspended

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

    Suspended

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Suspended

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Suspended

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

    Suspended

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

    Suspended

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Suspended

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

    Suspended

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Active, not recruiting

  • Maimonides Medical Center

    Brooklyn, New York, 11219

    Active, not recruiting

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

    Active, not recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Active, not recruiting

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Suspended

  • Saint Anne Hospital

    Burien, Washington, 98166

    Active, not recruiting

  • Lahey Clinic

    Burlington, Massachusetts, 01805

    Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org

    Julio Hajdenberg

    Recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

    Suspended

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Suspended

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527

    Suspended

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Suspended

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Suspended

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Suspended

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Suspended

  • Caro Cancer Center

    Caro, Michigan, 48723

    Suspended

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

    Suspended

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Suspended

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Suspended

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Suspended

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Active, not recruiting

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Suspended

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

    Active, not recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Tracy L. Rose

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Theodore S. Gourdin

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Active, not recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Manan Shah

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Active, not recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Randy F. Sweis

    Recruiting

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

    Site Public Contact, 877-779-7585, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Active, not recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    Active, not recruiting

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

    Suspended

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

    Active, not recruiting

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

    Active, not recruiting

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

    Active, not recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Melissa A. Reimers

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Suspended

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Suspended

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Community Cancer Institute

    Clovis, California, 93611

    Active, not recruiting

  • University Oncology Associates

    Clovis, California, 93611

    Active, not recruiting

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Suspended

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

    Active, not recruiting

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

    Active, not recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Amir Mortazavi

    Recruiting

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Samuel A. Funt

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Suspended

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Suspended

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

    Active, not recruiting

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

    Active, not recruiting

  • Northshore Oncology Associates-Covington

    Covington, Louisiana, 70433

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Victor T. Lin

    Recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Suspended

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Melissa A. Reimers

    Recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Suspended

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

    Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu

    Suzanne M. Cole

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Suzanne M. Cole

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Vamsi K. Vasireddy

    Recruiting

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

    Suspended

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Active, not recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Suspended

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Active, not recruiting

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Suspended

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • AdventHealth Porter

    Denver, Colorado, 80210

    Suspended

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org

    Tareq Al baghdadi

    Recruiting

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

    Suspended

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Suspended

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

    Active, not recruiting

  • Epic Care-Dublin

    Dublin, California, 94568

    Active, not recruiting

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

    Suspended

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

    Suspended

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Suspended

  • CommonSpirit Cancer Center Mercy

    Durango, Colorado, 81301

    Active, not recruiting

  • Mercy Medical Center

    Durango, Colorado, 81301

    Active, not recruiting

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Michael Husak

    Recruiting

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 855-776-0015

    Lance C. Pagliaro

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Yan Ji

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Suspended

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Vamsi K. Vasireddy

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

    Active, not recruiting

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

    Active, not recruiting

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

    Active, not recruiting

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

    Suspended

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

    Active, not recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Leonard J. Appleman

    Recruiting

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

    Active, not recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Suspended

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Suspended

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

    Suspended

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Suspended

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Saint Francis Hospital

    Federal Way, Washington, 98003

    Active, not recruiting

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

    Suspended

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

    Suspended

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

    Suspended

  • Orion Cancer Care

    Findlay, Ohio, 45840

    Suspended

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Suspended

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Site Public Contact, eileen.georgi@holy-cross.com

    Tareq Al baghdadi

    Recruiting

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

    Suspended

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Suzanne M. Cole

    Recruiting

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

    Suspended

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Suspended

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Suspended

  • Vanderbilt-Ingram Cancer Center Cool Springs

    Franklin, Tennessee, 37067

    Suspended

  • FMH James M Stockman Cancer Institute

    Frederick, Maryland, 21702

    Site Public Contact, 301-668-7043

    Patrick J. Mansky

    Recruiting

  • Unity Hospital

    Fridley, Minnesota, 55432

    Active, not recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Suspended

  • Central Ohio Breast and Endocrine Surgery

    Gahanna, Ohio, 43230

    Suspended

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Suspended

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

    Suspended

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Suspended

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

    Suspended

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

    Suspended

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Great Falls Clinic

    Great Falls, Montana, 59405

    Suspended

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

    Suspended

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Leonard J. Appleman

    Recruiting

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

    Suspended

  • Wayne Hospital

    Greenville, Ohio, 45331

    Suspended

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

    Suspended

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

    Suspended

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Samuel A. Funt

    Recruiting

  • HaysMed

    Hays, Kansas, 67601

    Site Public Contact, 785-623-5774

    Elizabeth M. Wulff

    Recruiting

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

    Suspended

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

    Suspended

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

    Suspended

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

    Suspended

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

    Suspended

  • Oncology Las Vegas - Henderson

    Henderson, Nevada, 89074

    Suspended

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

    Suspended

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

    Site Public Contact, 828-696-4716, pardeecancerresearch@unchealth.unc.edu

    John K. Hill

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting

  • Loyola Medicine Homer Glen

    Homer Glen, Illinois, 60491

    Suspended

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

    Suspended

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

    Active, not recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Fernando Maciel Barbosa

    Recruiting

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Suspended

  • Allegiance Health

    Jackson, Michigan, 49201

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Site Public Contact, 601-815-6700

    John C. Henegan

    Recruiting

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

    Suspended

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

    Suspended

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

    Suspended

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

    Active, not recruiting

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

    Suspended

  • Freeman Health System

    Joplin, Missouri, 64804

    Suspended

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

    Suspended

  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108

    Site Public Contact, 816-404-4375

    Elizabeth M. Wulff

    Recruiting

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

    Active, not recruiting

  • Ochsner Medical Center Kenner

    Kenner, Louisiana, 70065

    Active, not recruiting

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Site Public Contact, 509-783-4637, research@kadlecmed.org

    Alison K. Conlin

    Recruiting

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

    Suspended

  • First Dayton Cancer Care

    Kettering, Ohio, 45420

    Suspended

  • Kettering Medical Center

    Kettering, Ohio, 45429

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Suspended

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

    Suspended

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

    Active, not recruiting

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

    Active, not recruiting

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

    Suspended

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Active, not recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Active, not recruiting

  • CommonSpirit Saint Anthony Hospital Cancer Center

    Lakewood, Colorado, 80228

    Active, not recruiting

  • Saint Clare Hospital

    Lakewood, Washington, 98499

    Active, not recruiting

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Tareq Al baghdadi

    Recruiting

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

    Suspended

  • Desert West Surgery

    Las Vegas, Nevada, 89102

    Suspended

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

    Suspended

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

    Suspended

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

    Suspended

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

    Suspended

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

    Suspended

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

    Suspended

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

    Suspended

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

    Suspended

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

    Suspended

  • Las Vegas Prostate Cancer Center

    Las Vegas, Nevada, 89113

    Suspended

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

    Suspended

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89113

    Suspended

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

    Suspended

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

    Suspended

  • Cancer and Blood Specialists-Tenaya

    Las Vegas, Nevada, 89128

    Suspended

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

    Suspended

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

    Suspended

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

    Suspended

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

    Suspended

  • Oncology Las Vegas - Tenaya

    Las Vegas, Nevada, 89128

    Suspended

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

    Suspended

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

    Suspended

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

    Suspended

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

    Suspended

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

    Suspended

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

    Suspended

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

    Suspended

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

    Suspended

Other trials in United States

Puerto Rico1 site

  • Pan American Center for Oncology Trials LLC

    San Juan, 00902

    Active, not recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the efficacy of cabozantinib s-malate (cabozantinib) combined with nivolumab and ipilimumab in the first or second-line (and beyond) setting for patients within each of the rare genitourinary (GU) variant histology group of interest, as measured by objective response rate (ORR).

SECONDARY OBJECTIVES:

  1. To estimate the progression-free survival (PFS) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology.

II. To estimate the overall survival (OS) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology.

III. To estimate the clinical benefit rate (defined as complete response [CR] or partial response [PR] or stable disease [SD]) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology.

IV. To assess the safety of treating patients with rare variant histologies with cabozantinib combined with nivolumab and ipilimumab.

  1. To support tissue banking and collection of clinical follow-up data for GU tract rare histological variants.

EXPLORATORY OBJECTIVE:

  1. To assess effects of treatment in patients with bone-only disease by bone scan.

OUTLINE:

Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of cycles 1-4 and on days 1-28 of subsequent cycles. Patients also receive nivolumab intravenously (IV) over 30 minutes on day 1 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Patients then receive nivolumab IV over 30 minutes on day 1 of subsequent cycles. Treatment repeats every 21 days for cycles 1-4 and every 28 days for subsequent cycles for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo echocardiography during screening and undergo computed tomography (CT) or magnetic resonance imaging (MRI), bone scan and blood and urine sample collection throughout the trial and may undergo positron emission tomography (PET)/CT throughout the trial.

After completion of study treatment, patients are followed up every 2 months for up to 5 years.

Being tested
Biospecimen Collection, Bone Scan, Cabozantinib S-malate, Computed Tomography, Echocardiography Test
Medical subject headings
Carcinoma, Renal Cell, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Urogenital Neoplasms, Penile Neoplasms, Urethral Neoplasms, Prostatic Neoplasms, Urachal adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood and urine sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Cabozantinib S-malateDrug

    Also called BMS-907351, Cabometyx, Cometriq, XL 184

    Given PO

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT and/or PET/CT scan

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo echocardiography

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT scan

Study groups in NCT03866382
Study groupRoleWhat they receive
Treatment (cabozantinib, nivolumab, ipilimumab)ExperimentalPatients receive cabozantinib PO QD on days 1-21 of cycles 1-4 and on days 1-28 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Patients then receive nivolumab IV over 30 minutes on day 1 of subsequent cycles. Treatment repeats every 21 days for cycles 1-4 and every 28 days for subsequent cycles for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo echocardiography during screening and undergo CT or MRI, bone scan and blood and urine sample collection throughout the trial and may undergo PET/CT throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Cabozantinib S-malate; Procedure: Computed Tomography; Procedure: Echocardiography Test; Biological: Ipilimumab; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    An objective response is defined as a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Will be estimated by the number of confirmed objective responses divided by the total number of evaluable patients. Confidence intervals for the true ORR will be calculated.

    Measured: Up to 5 years

Secondary outcomes (5)

  1. Duration of response

    Defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.

    Measured: From time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years

  2. Progression-free survival (PFS)

    The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.

    Measured: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years

  3. Overall survival

    The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.

    Measured: Up to 5 years

  4. Clinical benefit rate (CBR)

    A confirmed clinical benefit is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart or a confirmed stable disease at two consecutive tumor assessments at least 3 months apart. The CBR will be estimated by the number of patients with confirmed clinical benefit divided by the total number of evaluable patients. Confidence intervals for the true CBR will be calculated using exact binomial confidence intervals.

    Measured: Up to 5 years

  5. Incidence of adverse events (AE)

    Will be assessed using Common Terminology Criteria for Adverse Events version 5.0. The maximum of a particular AE will be determined for each patient. Tables will summarize the number and relative frequency of patients observing an AE as well as the number and relative frequency of patients experiencing any AE of grade 3 or greater.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start13 May 2019
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03866382
Sponsor's protocol ID
NCI-2019-01266
Other IDs
NCI-2019-01266, A031702, A031702, U10CA180821
Status last verified
Aug 2026
First submitted
6 Mar 2019
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Publications

  • Girardi DM, Niglio SA, Mortazavi A, Nadal R, Lara P, Pal SK, Saraiya B, Cordes L, Ley L, Ortiz OS, Cadena J, Diaz C, Bagheri H, Redd B, Steinberg SM, Costello R, Chan KS, Lee MJ, Lee S, Yu Y, Gurram S, Chalfin HJ, Valera V, Figg WD, Merino M, Toubaji A, Streicher H, Wright JJ, Sharon E, Parnes HL, Ning YM, Bottaro DP, Cao L, Trepel JB, Apolo AB. Cabozantinib plus Nivolumab Phase I Expansion Study in Patients with Metastatic Urothelial Carcinoma Refractory to Immune Checkpoint Inhibitor Therapy. Clin Cancer Res. 2022 Apr 1;28(7):1353-1362. doi: 10.1158/1078-0432.CCR-21-3726.

    PubMed 35031545

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