AzTrials
AzTrials

Advanced Extrapulmonary Neuroendocrine CarcinomaPhase 2/3NCT05058651

Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung

A Phase 2/3 study testing Atezolizumab, Biospecimen Collection and Carboplatin in people with Advanced Extrapulmonary Neuroendocrine Carcinoma and Metastatic Extrapulmonary Neuroendocrine Carcinoma, run by National Cancer Institute (NCI) at 265 sites in United States.

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/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Biospecimen Collection and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
265 sitesUnited States
Study dates
28 Jun 2022to 1 Oct 2028
Phase
Phase 2/3

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

  • Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC)
  • Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator
  • Participants must have radiologically evaluable disease, measurable or non-measurable, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All measurable and nonmeasurable lesions must be assessed by CT scan with IV contrast of the chest/abdomen/and pelvis (or CT chest without contrast and MRI abdomen/pelvis with gadolinium contrast, if contraindication to CT iodinated contrast) within 28 days prior to registration. While may be used for routine clinical evaluation, PET scans and bone scans alone are not acceptable for disease assessment while participating in this study. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form
  • Participants must have brain MRI (or CT head with contrast if there is contraindication to MRI brain) if clinically indicated within 28 days prior to registration. Note: Brain imaging is not required in participants without known and/or clinical concern for brain metastases. Participants with asymptomatic central nervous system (CNS) metastases are eligible if one or more of the following apply:
  • Participants who have received treatment for brain metastases must have:
  • No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
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  • Discontinued all corticosteroids at least 14 days prior to registration
  • Participants with treatment-naive brain lesions must have:
  • No lesion measuring > 2.0 cm in size in any axis
  • MRI brain or CT head with contrast (if there is contraindication to MRI brain) demonstrating no evidence for mass effect, edema, or other impending neurological compromise within 28 days prior to registration
  • No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
  • No need for > 2 mg of dexamethasone (or equivalent of > 10 mg prednisone) per day at time of registration
  • Participants must not have symptomatic central nervous system (CNS) metastases
  • Participants must not have known or suspected leptomeningeal disease
  • Participants with prior history of non-metastatic (localized/locally advanced disease) extrapulmonary poorly differentiated NEC may have had prior platinum-based therapy +/- radiation +/- surgery provided that all therapy was completed >= 6 months prior to registration
  • Participants must discontinue denosumab prior to study registration and plan to replace with a bisphosphonate while on the study
  • Participants must not have had prior treatment for advanced or metastatic NEC EXCEPT one cycle of platinum (carboplatin/cisplatin) + etoposide is allowed prior to registration. Other chemotherapy regimens are not allowed. For participants with prostate or urothelial NEC, prior chemotherapy for the non-NEC component (e.g. adenocarcinoma or urothelial) is allowed as long as such therapy was completed >= 24 weeks prior to registration and participants have recovered from all prior toxicities to =< grade 1.
  • Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, CD137 agonists, anti-CTLA-4 agent, or any other immune checkpoint inhibitors for any neuroendocrine neoplasm. Immune checkpoint inhibitors given for other cancer indications are allowed provided last therapy was given at least 12 months prior to study registration
  • Participants must not have received treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin2 [IL-2] within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to registration
  • Participants must not have had history of known severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, including to Chinese hamster ovary cell products or to any component of the atezolizumab formulation, cisplatin, carboplatin, or etoposide
  • Participants must not be on active systemic therapy for another cancer with the exception of hormonal therapy including androgen deprivation therapy (e.g., gonadotropin-releasing hormone [GnRH] agonists or antagonists), which can be continued while participants are receiving protocol therapy. Use of enzalutamide or apalutamide is permitted after completion of chemotherapy and must be held during chemotherapy for participants receiving prior to enrollment. Use of darolutamide is permitted during chemotherapy. Glucocorticoid-containing regimens, including abiraterone, are not permitted.
  • Participants must be >= 18 years of age
  • Participants must have a Zubrod performance status of =< 2 within 28 days prior to registration
  • Participants must have a complete medical history and physical exam within 28 days prior to registration
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Hemoglobin >= 9.0 g/dl (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Platelet count >= 100 x 10^9/L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Serum total bilirubin =< 1.5 x ULN (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Adequate renal function as defined by any 1 of the following: 1) Measured creatinine clearance (CL) > 50 mL/min OR 2) Calculated creatinine CL > 50 mL/min by the Cockcroft-Gault formula OR by 24-hour urine collection for determination of creatinine clearance (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Participants must not have uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) within 14 days prior to registration. Participants who have asymptomatic hypercalcemia are eligible provided that medical therapy to treat the hypercalcemia is planned
  • Participants must not have a diagnosis of immunodeficiency nor be receiving systemic steroid therapy (equivalent of > 20 mg of hydrocortisone per day) or any other form of immunosuppressive therapy within 14 days prior to registration
  • Participants must not have active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
  • Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • Participants must not have history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Participants must not have significant cardiovascular disease, such as New York Heart Association class II or greater cardiac disease, myocardial infarction within 3 months prior to registration, unstable arrythmias, or unstable angina
  • Participants must not have had a major surgical procedure other than for diagnosis within 28 days prior to registration. Participant must not plan to receive a major surgical procedure during the course of protocol treatment. NOTE: Patient port placement is not considered a major surgery
  • Participants must not have severe infections (i.e., Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) at time of registration, including but not limited to hospitalization for complications for infection, bacteremia, or severe pneumonia
  • Participants must not have known active tuberculosis
  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load, with testing performed as clinically indicated
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load, with testing performed as clinically indicated
  • Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months of registration
  • Participants must not have prior allogeneic bone marrow transplantation or solid organ transplant
  • Participants must not have received administration of a live, attenuated vaccine (e.g., FluMist [registered trademark]) within 28 days prior to initiation of study treatment, during treatment with atezolizumab, and not plan to receive for 5 months after the last dose of atezolizumab
  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method (with details provided as a part of the consent process) during the treatment period and for 5 months after the final dose of atezolizumab. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

Who cannot join

None listed.

Trial locations and contacts

265 sites in 1 country. Contact the study team or a site near you to ask about taking part.

265 sites in 1 country

United States265 sites, 240 recruiting

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-539-2273, info@hawaiicancercare.com

    Elizabeth S. Nakasone

    Recruiting

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

    Suspended

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

    Site Public Contact, rohta@queens.org

    Elizabeth S. Nakasone

    Recruiting

  • 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

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Alaska Women's Cancer Care

    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

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Vaibhav Sahai

    Recruiting

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Suspended

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

    Site Public Contact, 225-765-7659, research@ololrmc.com

    Marshall P. Stagg

    Recruiting

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

    Site Public Contact, 225-765-7659, research@ololrmc.com

    Marshall P. Stagg

    Recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Saint Charles Health System

    Bend, Oregon, 97701

    Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org

    Charles W. Drescher

    Recruiting

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

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

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

    Site Public Contact, 800-648-6274

    Patrick W. Cobb

    Recruiting

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

    Suspended

  • United Hospital Center

    Bridgeport, West Virginia, 26330

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Nour Daboul

    Recruiting

  • 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

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

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

    Haythem Y. Ali

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Active, not recruiting

  • Lahey Clinic

    Burlington, Massachusetts, 01805

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

    Andrew Piper-Vallillo

    Recruiting

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

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

    David M. King

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • 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

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

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

    Bryan A. Faller

    Recruiting

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org

    Shahzad Siddique

    Recruiting

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

    Site Public Contact, 515-689-7658, sbenson@iora.org

    Seema Harichand-Herdt

    Recruiting

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

    Site Public Contact, NCTNStudyTeam@dm.duke.edu

    Tucker Coston

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

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

    Bryan A. Faller

    Recruiting

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

    Site Public Contact, 717-217-6020

    Marianne Spengler

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Suspended

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Earle F. Burgess

    Recruiting

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

    Site Public Contact, 980-442-2000

    Earle F. Burgess

    Recruiting

  • Levine Cancer Institute-SouthPark

    Charlotte, North Carolina, 28211

    Site Public Contact, 980-442-2000

    Earle F. Burgess

    Recruiting

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

    Site Public Contact, 800-804-9376

    Earle F. Burgess

    Recruiting

  • Levine Cancer Institute-Ballantyne

    Charlotte, North Carolina, 28277

    Site Public Contact, 800-804-9376

    Earle F. Burgess

    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

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Mary F. Mulcahy

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

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

    Ardaman Shergill

    Recruiting

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • 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

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

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

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

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

    John M. Schallenkamp

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

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

    Bhavana Konda

    Recruiting

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Site Public Contact, 800-804-9376

    Earle F. Burgess

    Recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Active, not recruiting

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

    Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Ardaman Shergill

    Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu

    Namrata I. Peswani

    Recruiting

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

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

    Namrata I. Peswani

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

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

    Namrata I. Peswani

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

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

    Vamsi K. Vasireddy

    Recruiting

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

    Site Public Contact, 248-551-7695

    Andrew A. Muskovitz

    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

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

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Mary F. Mulcahy

    Recruiting

  • AdventHealth Porter

    Denver, Colorado, 80210

    Site Public Contact, research.institute@adventhealth.com

    Yousuf A. Gaffar

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • 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

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Site Public Contact, 515-282-2200

    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

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Active, not 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

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

    Active, not recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Tucker Coston

    Recruiting

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

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

    Dean A. Delmastro

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

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

    David M. King

    Recruiting

  • Minnesota Oncology - Edina

    Edina, Minnesota, 55435

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

    David M. King

    Recruiting

  • 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

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

    Site Public Contact, 717-721-4840

    Marianne Spengler

    Recruiting

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Active, not recruiting

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

    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

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    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

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

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

    Namrata I. Peswani

    Recruiting

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Levine Cancer Institute-Gaston

    Gastonia, North Carolina, 28054

    Site Public Contact, 800-804-9376

    Earle F. Burgess

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Mary F. Mulcahy

    Recruiting

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

    Site Public Contact, 877-441-7957

    Marianne Spengler

    Recruiting

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

    Suspended

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Mary F. Mulcahy

    Recruiting

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Tareq Al baghdadi

    Recruiting

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Mary F. Mulcahy

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

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

    John M. Schallenkamp

    Recruiting

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • 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

    Site Public Contact, 313-343-3166, karen.forman@ascension.org

    Tareq Al baghdadi

    Recruiting

  • 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

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • WellSpan Medical Oncology and Hematology

    Hanover, Pennsylvania, 17331

    Site Public Contact, 717-632-1559

    Marianne Spengler

    Recruiting

  • Kaiser Permanente South Bay

    Harbor City, California, 90710

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Suspended

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

    Site Public Contact, 708-915-4673, clinicaltrials@ingalls.org

    James A. Wallace

    Recruiting

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-524-6115, i.webster@hawaiicancercare.com

    Elizabeth S. Nakasone

    Recruiting

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-532-0315

    Elizabeth S. Nakasone

    Recruiting

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-545-8548

    Elizabeth S. Nakasone

    Recruiting

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-522-4333

    Elizabeth S. Nakasone

    Recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-586-2979

    Elizabeth S. Nakasone

    Recruiting

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

    Site Public Contact, 808-531-8521

    Elizabeth S. Nakasone

    Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Tannaz Armaghany

    Recruiting

  • Ben Taub General Hospital

    Houston, Texas, 77030

    Site Public Contact, 713-873-2000

    Tannaz Armaghany

    Recruiting

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Allegiance Health

    Jackson, Michigan, 49201

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

    Haythem Y. Ali

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Site Public Contact, 855-776-0015

    Jacob Orme

    Recruiting

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

    Site Public Contact, 910-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

    Suspended

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

    Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net

    Jay W. Carlson

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Logan Health Medical Center

    Kalispell, Montana, 59901

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

    John M. Schallenkamp

    Recruiting

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

    Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org

    David E. Marinier

    Recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Site Public Contact, cancertrials@northwestern.edu

    Mary F. Mulcahy

    Recruiting

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan, 48910

    Active, not recruiting

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

    Site Public Contact, 877-231-4440

    Sagila George

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Kathryn C. Hourdequin

    Recruiting

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

    Site Public Contact, 717-741-8303, doxenberg@wellspan.org

    Marianne Spengler

    Recruiting

  • AdventHealth Littleton

    Littleton, Colorado, 80122

    Site Public Contact, research.institute@adventhealth.com

    Yousuf A. Gaffar

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

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

    Tareq Al baghdadi

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

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

    Tareq Al baghdadi

    Recruiting

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

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

    Tareq Al baghdadi

    Recruiting

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

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

    Dean A. Delmastro

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

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

    Vamsi K. Vasireddy

    Recruiting

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Tara Castellano

    Recruiting

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Tara Castellano

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Alexandria T. Phan

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

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

    David M. King

    Recruiting

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

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

    David M. King

    Recruiting

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

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

    Dean A. Delmastro

    Recruiting

  • Community Medical Center

    Missoula, Montana, 59804

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

    John M. Schallenkamp

    Recruiting

  • Memorial Medical Center

    Modesto, California, 95355

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Nour Daboul

    Recruiting

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

    Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com

    Jay W. Carlson

    Recruiting

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Tareq Al baghdadi

    Recruiting

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

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

    Tareq Al baghdadi

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Suspended

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

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

    Ardaman Shergill

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Tara Castellano

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Active, not recruiting

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Charles W. Drescher

    Recruiting

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

    Site Public Contact, 616-391-1230

    Kathleen Y. Butler

    Recruiting

  • Carle BroMenn Medical Center

    Normal, Illinois, 61761

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

    Vamsi K. Vasireddy

    Recruiting

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

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

    Vamsi K. Vasireddy

    Recruiting

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

    Suspended

  • Henry Ford Medical Center-Columbus

    Novi, Michigan, 48377

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

    Haythem Y. Ali

    Recruiting

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

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

    Bryan A. Faller

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Sagila George

    Recruiting

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

    Site Public Contact, 405-752-3402

    Jay W. Carlson

    Recruiting

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Charles W. Drescher

    Recruiting

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Mary F. Mulcahy

    Recruiting

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

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

    Ardaman Shergill

    Recruiting

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • AdventHealth Parker

    Parker, Colorado, 80138

    Site Public Contact, research.institute@adventhealth.com

    Yousuf A. Gaffar

    Recruiting

  • Lahey Clinic Peabody

    Peabody, Massachusetts, 01960

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

    Andrew Piper-Vallillo

    Recruiting

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

    Site Public Contact, 855-776-0015

    Jacob Orme

    Recruiting

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

    Site Public Contact, 910-715-3500, jcwilliams@firsthealth.org

    Charles S. Kuzma

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

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

    Tareq Al baghdadi

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Charles W. Drescher

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Charles W. Drescher

    Recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

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

    John M. Schallenkamp

    Recruiting

  • Duke Cancer Center Raleigh

    Raleigh, North Carolina, 27609

    Site Public Contact, NCTNStudyTeam@dm.duke.edu

    Tucker Coston

    Recruiting

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

    Site Public Contact, 605-755-2370, research@monument.health

    Abdel-Ghani Azzouqa

    Recruiting

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

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

    Dean A. Delmastro

    Recruiting

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

    Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu

    Namrata I. Peswani

    Recruiting

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Jacob Orme

    Recruiting

  • Levine Cancer Institute-Rock Hill

    Rock Hill, South Carolina, 29732

    Site Public Contact, 800-804-9376

    Earle F. Burgess

    Recruiting

  • UW Health Carbone Cancer Center Rockford

    Rockford, Illinois, 61114

    Site Public Contact, 779-696-9378, lkline@uwhealth.org

    Fahrettin Covut

    Recruiting

  • Mercy Cancer Center - Rocklin

    Rocklin, California, 95765

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Sutter Roseville Medical Center

    Roseville, California, 95661

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

    Suspended

  • Mercy Cancer Center - Sacramento

    Sacramento, California, 95816

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

    Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org

    Kathryn C. Hourdequin

    Recruiting

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

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

    David M. King

    Recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

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

    David M. King

    Recruiting

  • United Hospital

    Saint Paul, Minnesota, 55102

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

    David M. King

    Recruiting

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Heloisa P. Soares

    Recruiting

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

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

    John M. Schallenkamp

    Recruiting

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

    Site Public Contact, 415-209-2683, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Site Public Contact, 800-804-8824

    David B. Zhen

    Recruiting

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

    Site Public Contact, 800-804-8824

    David B. Zhen

    Recruiting

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

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

    David M. King

    Recruiting

  • Atrium Health Cleveland/LCI-Cleveland

    Shelby, North Carolina, 28150

    Site Public Contact, 800-804-9376

    Earle F. Burgess

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Smilow Cancer Hospital Care Center at Long Ridge

    Stamford, Connecticut, 06902

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

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

    Dean A. Delmastro

    Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Active, not recruiting

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Mintallah Haider

    Recruiting

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

    Suspended

  • Smilow Cancer Hospital-Torrington Care Center

    Torrington, Connecticut, 06790

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • Munson Medical Center

    Traverse City, Michigan, 49684

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Beaumont Troy Hospital

    Troy, Michigan, 48085

    Site Public Contact, 248-551-7695

    Andrew A. Muskovitz

    Recruiting

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

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

    Vamsi K. Vasireddy

    Recruiting

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

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

    Tareq Al baghdadi

    Recruiting

  • Henry Ford Madison Heights Hospital - Breast

    Warren, Michigan, 48093

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

    Tareq Al baghdadi

    Recruiting

  • Henry Ford Warren Hospital - GLCMS

    Warren, Michigan, 48093

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

    Tareq Al baghdadi

    Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Mary F. Mulcahy

    Recruiting

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

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

    Haythem Y. Ali

    Recruiting

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Smilow Cancer Hospital Care Center - Westerly

    Westerly, Rhode Island, 02891

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Matthew Austin

    Recruiting

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

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

    Dean A. Delmastro

    Recruiting

  • Woodland Memorial Hospital

    Woodland, California, 95695

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Kaiser Permanente-Woodland Hills

    Woodland Hills, California, 91367

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Helen H. Moon

    Recruiting

  • Henry Ford Wyandotte Hospital

    Wyandotte, Michigan, 48192

    Site Public Contact, nhay@hfhs.org

    Haythem Y. Ali

    Recruiting

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

    Suspended

  • WellSpan Health-York Cancer Center

    York, Pennsylvania, 17403

    Site Public Contact, 877-441-7957

    Marianne Spengler

    Recruiting

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560

    Suspended

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

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

    Tareq Al baghdadi

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

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

    Tareq Al baghdadi

    Recruiting

Other trials in United States

About this study

Official title: Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3).

II. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3).

III. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2).

SECONDARY OBJECTIVES:

  1. To compare overall survival (OS), measured from start of observation/maintenance, across arms.

II. To compare progression free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms.

III. To compare objective response rate (ORR = confirmed and unconfirmed partial response [PR] + confirmed and unconfirmed complete response [CR]) across arms among patients with measurable disease at randomization.

IV. To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease [SD]) across arms among patients with measurable disease at randomization.

  1. To compare duration of response (DOR) across arms. VI. To evaluate the safety and tolerability of each arm.

ADDITIONAL OBJECTIVE:

  1. To bank tumor and blood samples for future biomarker correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: During induction phase, patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 7/9/26): During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year.

ARM III: During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year.

Patients in all arms also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial and blood sample collection on study.

After completion of study treatment, patients are followed up for 5 years.

Being tested
Atezolizumab, Biospecimen Collection, Carboplatin, Cisplatin, Computed Tomography

What participants receive

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

  • AtezolizumabBiological

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • Biospecimen CollectionProcedure or surgery

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

    Undergo blood sample collection

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

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

    Undergo CT scan

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    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

  • Patient ObservationOther

    Also called Active Surveillance, deferred therapy, expectant management, Observation

    Undergo observation

Study groups in NCT05058651
Study groupRoleWhat they receive
Arm I (atezolizumab, platinum drug, etoposide)ExperimentalDuring induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Receives: Biological: Atezolizumab; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Etoposide; Procedure: Magnetic Resonance Imaging
Arm II (atezolizumab, platinum drug, etoposide, observation)ExperimentalDuring induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study. (CLOSED TO ACCRUAL 7/9/26)
Receives: Biological: Atezolizumab; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Other: Patient Observation
Arm III (platinum drug, etoposide, observation)Active comparatorDuring induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Other: Patient Observation

What is being measured

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

  1. Overall survival

    Log-rank tests stratified by the randomization stratification factors will be used for null hypothesis (efficacy) tests. Cox regression models stratified by the randomization stratification factors will be used for alternative hypothesis (futility) tests.

    Measured: From date of registration or from date of start of observation/maintenance therapy to date of death due to any cause, assessed up to 5 years

Secondary outcomes (4)

  1. Progression-free survival

    Will be estimated using the Kaplan-Meier method and compared using log-rank tests.

    Measured: From date of registration or start of observation/maintenance therapy to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years

  2. Duration of response

    Will be estimated non-parametrically using cumulative incidence curves.

    Measured: Time from date of initial response to date of progression or death, assessed up to 5 years

  3. Objective response rate (confirmed complete response [CR] or partial response [PR])

    Will be tabulated and compared between arms using Fisher's exact test.

    Measured: Up to 5 years from study enrollment

  4. Clinical benefit rate (confirmed CR or PR of any amount of time or stable disease for 6 months or longer)

    Will be tabulated and compared between arms using Fisher's exact test.

    Measured: Up to 5 years from study enrollment

Timeline

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

  1. First posted28 Sep 2021
  2. Study start28 Jun 2022
  3. Primary completion1 Oct 2028 (estimated)
  4. Study completion1 Oct 2028 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
189 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05058651
Sponsor's protocol ID
NCI-2021-09851
Other IDs
NCI-2021-09851, S2012, S2012, U10CA180888
Status last verified
Oct 2026
First submitted
25 Sep 2021
Last updated
23 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.

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