AzTrials
AzTrials

Advanced Esophageal AdenocarcinomaPhase 2/3NCT06203600

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

A Phase 2/3 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Advanced Esophageal Adenocarcinoma and Advanced Gastric Adenocarcinoma, run by National Cancer Institute (NCI) at 378 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
Search all trials

Trial summary

This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
378 sitesUnited States
Study dates
24 Jun 2024to 31 Oct 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma
  • Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen
  • Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma
  • Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
  • Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration
  • Participants must have disease progression or intolerance to frontline standard of care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs while on the therapy or within 6 months of completing the chemotherapy plus nivolumab or pembrolizumab or other PD-1/PD-L1 inhibitor cycle
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  • Participants must not have received more than one prior line of systemic therapy defined as chemotherapy plus either nivolumab, pembrolizumab, or any other PD-1 or PD-L1 inhibitor, in the stage IV or unresectable setting. Peri-operative or adjuvant nivoluamb or other PD-1/PD-L1 inhibitors would count as one prior line of systemic therapy if patients progressed while on nivolumab (or other PD-1/PD-L1 inhibitors) or within 6 months of stopping it
  • Note: Radiation or any other regional therapy options done to address local residual disease or metastatic disease would not count as a line of therapy. Maintenance therapy with a different form of fluoropyrimidine (i.e. switching from capecitabine to fluorouracil [5FU]) would not count as another line of therapy
  • Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of ≥ 7 days prior to registration
  • Participants must not have prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agent including events like pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia gravis. Participants with endocrinopathy events leading or not to replacement steroids, thyroid hormone, insulin, or cortisol are eligible
  • Participants must not have received a live attenuated vaccination within 28 days prior to registration
  • Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration
  • Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded
  • Participants must not have plans to undergo elective or planned major surgery during the clinical trial
  • Participants must not have active bleeding or prior history of gastrointestinal (GI) perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic or surgical intervention) within 84 days prior to registration
  • Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
  • Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
  • Participants must not have a history of grade 3 or 4 immunotherapy related toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid derangements
  • Participants must be ≥ 18 years old
  • Participants must have Zubrod Performance Status of 0-2
  • Participants must have a complete medical history and physical exam within 28 days prior to registration
  • Leukocytes ≥ 2 x 10^3/uL (within 28 days prior to registration)
  • Absolute neutrophil count ≥ 1.2 x 10^3/uL (within 28 days prior to registration)
  • Hemoglobin ≥ 9.0 g/dL (within 28 days prior to registration)
  • Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) (unless liver metastases are present, in which case they must be ≤ 5 x ULN)
  • Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
  • Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration. Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
  • Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better
  • Participants must have recovered to baseline or < grade 2 CTCAE version (v) 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically stable on supportive therapy
  • Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration
  • Participants must not have uncontrolled blood pressure within 28 days prior to registration as determined by the treating investigator
  • Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration
  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to registration, if indicated
  • Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). 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. 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 not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis). Note: Participants with Graves' disease will be allowed
  • Participants must not have a history of pneumonitis that has required oral or IV steroids within the last 12 months prior to registration
  • 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 who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE) questionnaires in English or Spanish must participate in the quality of life studies
  • 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. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Who cannot join

None listed.

Trial locations and contacts

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

300 sites in 1 country

United States300 sites, 264 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

    Site Public Contact, 808-486-6000

    Elizabeth S. Nakasone

    Recruiting

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

    Site Public Contact, rohta@queens.org

    Elizabeth S. Nakasone

    Recruiting

  • Lovelace Medical Center-Saint Joseph Square

    Albuquerque, New Mexico, 87102

    Site Public Contact, 505-272-0530, ZPollock@salud.unm.edu

    Jessica Belmonte

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Jessica Belmonte

    Recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

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

    Tareq Al baghdadi

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

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

    John M. Schallenkamp

    Recruiting

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

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

    Gary L. Buchschacher

    Recruiting

  • 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

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • Cone Health Cancer Center at Asheboro

    Asheboro, North Carolina, 27203

    Suspended

  • Cone Health MedCenter Asheboro

    Asheboro, North Carolina, 27205

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

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

    Bret E. Friday

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Oluwadunni Emiloju

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Oluwadunni Emiloju

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Oluwadunni Emiloju

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Suspended

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Edward S. James

    Recruiting

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

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

    Gary L. Buchschacher

    Recruiting

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Edward S. James

    Recruiting

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

    Site Public Contact, 516-734-8896

    Crystal Antoine-Pepeljugoski

    Recruiting

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Anwaar Saeed

    Recruiting

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

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

    Mridula Krishnan

    Recruiting

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

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

    Gary L. Buchschacher

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Active, not recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

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

    Tareq Al baghdadi

    Recruiting

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

    Site Public Contact, towercancerresearch@toweroncology.com

    Jun Gong

    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

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Suspended

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

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

    Tareq Al baghdadi

    Recruiting

  • 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

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

    Bret E. Friday

    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

    Gazala Khan

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Kannan Thanikachalam

    Recruiting

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Active, not recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Active, not recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

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

    Edward S. James

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

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

    Tareq Al baghdadi

    Recruiting

  • 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

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

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

    Bryan A. Faller

    Recruiting

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

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

    Seema Harichand-Herdt

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Suspended

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-365-4673

    Deborah W. Wilbur

    Recruiting

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-363-2690

    Deborah W. Wilbur

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

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

    Tarek M. Sabagh

    Recruiting

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

    Site Public Contact, 843-789-7020, ashley.salvo@va.gov

    Oleksandra Lupak

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

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

    Toros Dincman

    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

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Daniel Lin

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

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

    Aparna Kalyan

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Yolande Chen

    Recruiting

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

    Site Public Contact, 773-878-8200

    Lauren A. Wiebe

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Active, not recruiting

  • Northwestern Medicine Cancer Center Old Irving Park

    Chicago, Illinois, 60641

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Aparna Kalyan

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Edward S. James

    Recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    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

    Patrick Grierson

    Recruiting

  • 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

    Gazala Khan

    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

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Shin Yin Lee

    Recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Site Public Contact, 719-364-6700

    Shin Yin Lee

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

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

    David M. King

    Recruiting

  • Ochsner Hematology Oncology North Shore - Covington (West Region)

    Covington, Louisiana, 70433

    Site Public Contact, 985-809-5668, Cheryl.kesler@ochsner.org

    Jonathan D. Mizrahi

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

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

    Patrick Grierson

    Recruiting

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

    Site Public Contact, 219-836-6879, CancerResearch@powershealth.org

    Suparna Mantha

    Recruiting

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

    Active, not recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Edward S. James

    Recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

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

    Edward S. James

    Recruiting

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

    Site Public Contact, 240-964-1400

    Anwaar Saeed

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

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

    Suparna Mantha

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Mina Makary

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

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

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

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

    Tarek M. Sabagh

    Recruiting

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

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

    Gazala Khan

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org

    Oluwadunni Emiloju

    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

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

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

    Bret E. Friday

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

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

    Aparna Kalyan

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

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

    Yifei Zhang

    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

  • 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

    Gazala Khan

    Recruiting

  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

    Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu

    Mina Makary

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Suspended

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Edward S. James

    Recruiting

  • Kaiser Permanente Dublin

    Dublin, California, 94568

    Site Public Contact, 877-642-4691

    Tilak K. Sundaresan

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

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

    Bret E. Friday

    Recruiting

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Suparna Mantha

    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

    Seth O. Fagbemi

    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

    Suparna Mantha

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

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

    Bryan A. Faller

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Edward S. James

    Recruiting

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

    Active, not recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

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

    Anwaar Saeed

    Recruiting

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Suspended

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

    Site Public Contact, 847-570-2109

    Lauren A. Wiebe

    Recruiting

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

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

    Yifei Zhang

    Recruiting

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

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

    Bret E. Friday

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Farmington Health Center

    Farmington, Utah, 84025

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

    Christopher D. Nevala-Plagemann

    Recruiting

  • 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

    Gary L. Buchschacher

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Site Public Contact, 970-297-6150

    Shin Yin Lee

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Site Public Contact, protocols@swog.org

    Shin Yin Lee

    Recruiting

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

    Site Public Contact, 515-282-2921, trials@missioncancer.com

    Seema Harichand-Herdt

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

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

    Tarek M. Sabagh

    Recruiting

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Tilak K. Sundaresan

    Recruiting

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California, 93720

    Site Public Contact, 833-574-2273

    Tilak K. Sundaresan

    Recruiting

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Tilak K. Sundaresan

    Recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Suspended

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

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

    Aparna Kalyan

    Recruiting

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

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

    Edward S. James

    Recruiting

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

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

    Yifei Zhang

    Recruiting

  • Glens Falls Hospital

    Glens Falls, New York, 12801

    Active, not recruiting

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

    Site Public Contact, 847-570-2109

    Lauren A. Wiebe

    Recruiting

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Aparna Kalyan

    Recruiting

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

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

    Samer S. Kasbari

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

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

    Edward S. James

    Recruiting

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Aparna Kalyan

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

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

    John M. Schallenkamp

    Recruiting

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

    Site Public Contact, protocols@swog.org

    Shin Yin Lee

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

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

    Edward S. James

    Recruiting

  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

    Site Public Contact, 516-734-8896

    Crystal Antoine-Pepeljugoski

    Recruiting

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • Cone Health Cancer Center at Drawbridge Parkway

    Greensboro, North Carolina, 27410

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Anwaar Saeed

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

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

    Yifei Zhang

    Recruiting

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

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

    Yifei Zhang

    Recruiting

  • Kaiser Permanente South Bay

    Harbor City, California, 90710

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

    Gary L. Buchschacher

    Recruiting

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

    Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org

    Anwaar Saeed

    Recruiting

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

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

    Yifei Zhang

    Recruiting

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

    Active, not recruiting

  • HaysMed

    Hays, Kansas, 67601

    Site Public Contact, 785-623-5774

    Gary C. Doolittle

    Recruiting

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

    Site Public Contact, 708-799-9995

    Edward S. James

    Recruiting

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

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

    Tareq Al baghdadi

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

    Site Public Contact, 847-570-2109

    Lauren A. Wiebe

    Recruiting

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

    Site Public Contact, 219-947-1795

    Suparna Mantha

    Recruiting

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

    Site Public Contact, 219-836-6875, CancerResearch@COMHS.org

    Suparna Mantha

    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

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

    Site Public Contact, 808-531-8521

    Elizabeth S. Nakasone

    Recruiting

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

    Site Public Contact, 808-432-5195, shelley.a.clark@kp.org

    Tilak K. Sundaresan

    Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Site Public Contact, 808-983-6090

    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

    Karen Riggins

    Recruiting

  • Ben Taub General Hospital

    Houston, Texas, 77030

    Site Public Contact, 713-873-2000

    Karen Riggins

    Recruiting

  • Saint Catherine Hospital

    Indianapolis, Indiana, 46312

    Site Public Contact, protocols@swog.org

    Suparna Mantha

    Recruiting

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

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

    Gary L. Buchschacher

    Recruiting

  • Allegiance Health

    Jackson, Michigan, 49201

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

    Gazala Khan

    Recruiting

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

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

    Samer S. Kasbari

    Recruiting

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

    Site Public Contact, 404-778-5714, m.lisa.hwang@emory.edu

    Oluwadunni Emiloju

    Recruiting

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

    Site Public Contact, 814-534-4724

    Anwaar Saeed

    Recruiting

  • 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

    Gary C. Doolittle

    Recruiting

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

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

    Edward S. James

    Recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Suspended

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

    Site Public Contact, 865-544-9773

    Saikrishna Gadde

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Aaron Miller

    Recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Site Public Contact, cancertrials@northwestern.edu

    Aparna Kalyan

    Recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Site Public Contact, 516-734-8896

    Crystal Antoine-Pepeljugoski

    Recruiting

  • Lancaster General Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

    Active, not recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

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

    Tareq Al baghdadi

    Recruiting

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

    Suspended

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89183

    Suspended

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

    Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG

    Gary C. Doolittle

    Recruiting

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

    Site Public Contact, 877-231-4440

    Hassan Hatoum

    Recruiting

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

    Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu

    Mina Makary

    Recruiting

  • CommonSpirit Saint Joseph Medical Center - East Lexington

    Lexington, Kentucky, 40509

    Active, not recruiting

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Edward S. James

    Recruiting

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Edward S. James

    Recruiting

  • Baptist Health Medical Center - Little Rock

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-202-4715

    Rangaswamy Govindarajan

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-686-8274

    Rangaswamy Govindarajan

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

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

    Tareq Al baghdadi

    Recruiting

  • Keck Medicine of USC Koreatown

    Los Angeles, California, 90020

    Site Public Contact, 213-388-0908

    Syma Iqbal

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

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

    Gary L. Buchschacher

    Recruiting

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

    Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu

    Syma Iqbal

    Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Site Public Contact, 323-865-0451

    Syma Iqbal

    Recruiting

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

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

    Gary L. Buchschacher

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org

    Jun Gong

    Recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

    Site Public Contact, 970-203-7083

    Shin Yin Lee

    Recruiting

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Suspended

  • William S Middleton VA Medical Center

    Madison, Wisconsin, 53705

    Site Public Contact, 608-256-1901 ext. 17007

    Sam J. Lubner

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Nataliya V. Uboha

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Nataliya V. Uboha

    Recruiting

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

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

    David M. King

    Recruiting

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

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

    Edward S. James

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

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

    Seth O. Fagbemi

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

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

    Suparna Mantha

    Recruiting

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Anwaar Saeed

    Recruiting

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Site Public Contact, 305-674-2625, Yvonne.Enriquez@msmc.com

    Mike Cusnir

    Recruiting

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

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

    Edward S. James

    Recruiting

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

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

    Edward S. James

    Recruiting

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

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

    Edward S. James

    Recruiting

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Site Public Contact, 212-263-4432, cancertrials@nyulangone.org

    Jennifer W. Chuy

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    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

    Seth O. Fagbemi

    Recruiting

  • Community Medical Center

    Missoula, Montana, 59804

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

    John M. Schallenkamp

    Recruiting

  • Kaiser Permanente- Modesto MOB II

    Modesto, California, 95356

    Site Public Contact, 877-642-4691

    Tilak K. Sundaresan

    Recruiting

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Tilak K. Sundaresan

    Recruiting

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

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

    Anwaar Saeed

    Recruiting

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

    Site Public Contact, 914-666-1366, AMellor@northwell.edu

    Crystal Antoine-Pepeljugoski

    Recruiting

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

    Site Public Contact, research.institute@phci.org

    Timothy R. Wassenaar

    Recruiting

  • The Community Hospital

    Munster, Indiana, 46321

    Site Public Contact, 219-836-3349

    Suparna Mantha

    Recruiting

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

    Site Public Contact, 219-934-8869, mnicholson@comhs.org

    Suparna Mantha

    Recruiting

  • Arnold Palmer Cancer Center Medical Oncology Norwin

    N. Huntingdon, Pennsylvania, 15642

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

    Anwaar Saeed

    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

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Anwaar Saeed

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

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

    Yifei Zhang

    Recruiting

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

    Active, not recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

    Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org

    Jonathan D. Mizrahi

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Site Public Contact, CancerTrials@nyulangone.org

    Jennifer W. Chuy

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

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

    Charles W. Drescher

    Recruiting

  • USC Norris Oncology/Hematology-Newport Beach

    Newport Beach, California, 92663

    Site Public Contact, 323-865-0451

    Syma Iqbal

    Recruiting

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

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

    Yifei Zhang

    Recruiting

  • Henry Ford Health Providence Novi Hospital

    Novi, Michigan, 48374

    Suspended

  • Henry Ford Medical Center-Columbus

    Novi, Michigan, 48377

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

    Gazala Khan

    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

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Aparna Kalyan

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

    Site Public Contact, 800-323-8622

    Edward S. James

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Tilak K. Sundaresan

    Recruiting

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

    Site Public Contact, 262-928-7878

    Timothy R. Wassenaar

    Recruiting

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

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

    Hassan Hatoum

    Recruiting

  • Integris Southwest Medical Center

    Oklahoma City, Oklahoma, 73109

    Suspended

  • Integris Cancer Institute of Oklahoma

    Oklahoma City, Oklahoma, 73142

    Suspended

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

    Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu

    Gary C. Doolittle

    Recruiting

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Site Public Contact, 402-559-5600

    Mridula Krishnan

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

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

    Mridula Krishnan

    Recruiting

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

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

    Gary L. Buchschacher

    Recruiting

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

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

    Tareq Al baghdadi

    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

    Aparna Kalyan

    Recruiting

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

    Active, not recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32803

    Site Public Contact, 407-303-2090, FH.Cancer.Research@flhosp.org

    Mohamedtaki A. Tejani

    Recruiting

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

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

    Edward S. James

    Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Suspended

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

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

    Gary L. Buchschacher

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Site Public Contact, 847-384-3621

    Edward S. James

    Recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

    Suspended

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

    Suspended

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Suspended

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Daniel Lin

    Recruiting

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Daniel Lin

    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

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

    Site Public Contact, 412-784-4900

    Anwaar Saeed

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Anwaar Saeed

    Recruiting

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

    Site Public Contact, 412-367-6454

    Anwaar Saeed

    Recruiting

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

    Site Public Contact, 412-502-3920

    Anwaar Saeed

    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

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Site Public Contact, 503-494-1080, trials@ohsu.edu

    Emerson Y. Chen

    Recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

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

    John M. Schallenkamp

    Recruiting

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

    Suspended

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

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

    Edward S. James

    Recruiting

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

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

    Abdel-Ghani Azzouqa

    Recruiting

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Annie Penn Memorial Hospital

    Reidsville, North Carolina, 27320

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Suspended

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

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

    Seth O. Fagbemi

    Recruiting

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

    Site Public Contact, ctoclinops@vcu.edu

    Jennifer L. Myers

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Jennifer L. Myers

    Recruiting

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

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

    Gary L. Buchschacher

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    Richard F. Dunne

    Recruiting

  • Mercyhealth Cancer Institute - Rockford

    Rockford, Illinois, 61114

    Site Public Contact, 815-971-5858, oncologyclinicaltrials@mhemail.org

    Mayur Narkhede

    Recruiting

Other trials in United States

About this study

Official title: Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS &gt;/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)

This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess whether progression-free survival (PFS) is sufficiently improved in participants randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab to warrant a phase III study with overall survival (OS) as the primary endpoint. (Phase II) II. To compare OS in participants randomized to nivolumab + paclitaxel + ramucirumab versus those randomized to paclitaxel + ramucirumab. (Phase III)

SECONDARY OBJECTIVES:

  1. To compare PFS between those randomized to nivolumab + paclitaxel + ramucirumab versus those randomized to paclitaxel + ramucirumab. (Phase III) II. To compare OS between participants randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab in the event that the trial is completed before the phase III portion.

III. To compare the overall response rate (ORR, including confirmed and unconfirmed, complete, and partial response, according to Response Evaluation Criteria in Solid Tumors [RECIST 1.1] criteria) between those randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab among participants with measurable disease.

IV. To compare the overall disease control rate (DCR = ORR + stable disease) between those randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab among participants with measurable disease.

  1. To evaluate the safety and tolerability of each treatment regimen. VI. To compare health-related quality of life (QOL) by treatment arm at 8 weeks after randomization, measured using the Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Trial Outcome Index (TOI).

VII. To compare health-related QOL between treatment arms at 8 weeks after randomization using the FACT-Ga total score.

VIII. To compare longitudinal changes in health-related QOL between treatment arms using FACT-Ga TOI up to 24 weeks after randomization.

IX. To compare patient-reported symptoms using selected Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) items including gastrointestinal as well as constitutional symptoms of fatigue, anorexia, and weight loss between treatment arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle, ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and magnetic resonance imaging (MRI) throughout the study. Patients may also optionally undergo blood sample collection on study.

ARM 2: Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. Patients may also optionally undergo blood sample collection on study.

After completion of study treatment, patients are followed up at 30, 60, 90 days and then every 6 months for up to 3 years.

Being tested
Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Nivolumab, Paclitaxel
Medical subject headings
Adenocarcinoma Of Esophagus

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 optional blood sample collection

  • Computed TomographyProcedure or surgery

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

    Undergo CT scan

  • 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

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Questionnaire AdministrationOther

    Ancillary studies

  • RamucirumabBiological

    Also called Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC 1121B, IMC-1121B

    Given IV

Study groups in NCT06203600
Study groupRoleWhat they receive
Arm 1 (nivolumab, ramucirumab, paclitaxel)ExperimentalPatients receive nivolumab IV over 30 minutes on day 1 of each cycle, ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. Patients may also optionally undergo blood sample collection on study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Drug: Paclitaxel; Other: Questionnaire Administration; Biological: Ramucirumab
Arm 2 (ramucirumab, paclitaxel)Active comparatorPatients receive ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. Patients may also optionally undergo blood sample collection on study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Other: Questionnaire Administration; Biological: Ramucirumab

What is being measured

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

  1. Progression free survival (PFS) (Phase II)

    The distribution of PFS will be estimated using the method of Kaplan-Meier and compared using a 1-sided stratified log-rank test.

    Measured: From date of randomization to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 3 years

  2. Overall survival (OS) (Phase III)

    The distribution of OS will be estimated using the method of Kaplan-Meier and compared using a 1-sided stratified log-rank test.

    Measured: From date of randomization to date of death due to any cause, assessed up to 3 years

Secondary outcomes (3)

  1. Objective response rate (ORR)

    Will be compared across arms in participants with measurable disease via Fisher's exact test.

    Measured: Up to 3 years

  2. Disease control rate (DCR)

    DCR = ORR + stable disease per Response Evaluation Criteria in Solid Tumors 1.1. Will be compared across arms in participants with measurable disease via Fisher's exact test.

    Measured: Up to 3 years

  3. Incidence of adverse events

    Measured: Up to 3 years

Timeline

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

  1. First posted12 Jan 2024
  2. Study start24 Jun 2024
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06203600
Sponsor's protocol ID
NCI-2023-11064
Other IDs
NCI-2023-11064, S2303, S2303, U10CA180888
Status last verified
Aug 2026
First submitted
10 Jan 2024
Last updated
30 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

  • Saeed A, Colby S, Oberstein PE, Duda DG, Park R, Agarwal R, Figueroa-Moseley C, Vaidya R, Unger JM, Guthrie KA, Rocha FG, Senthil M, Safyan RA, Wainberg ZA, Iqbal S, Chiorean EG, Philip PA. S2303: phase II/III trial of paclitaxel + ramucirumab +/- nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE). Future Oncol. 2025 May;21(11):1325-1331. doi: 10.1080/14796694.2025.2485020. Epub 2025 Mar 28.

    PubMed 40155326

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Advanced Esophageal Adenocarcinoma and Advanced Gastric Adenocarcinoma, run by National Cancer Institute (NCI) at 378 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 43 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 378 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (Phase II) (time frame: From date of randomization to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06203600, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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