Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
NCT ID: NCT06203600
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
224 participants
INTERVENTIONAL
2024-06-24
2027-10-31
Brief Summary
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Detailed Description
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I. 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:
I. 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.
V. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 (nivolumab, ramucirumab, paclitaxel)
Patients 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.
Biospecimen Collection
Undergo optional blood sample collection
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Paclitaxel
Given IV
Questionnaire Administration
Ancillary studies
Ramucirumab
Given IV
Arm 2 (ramucirumab, paclitaxel)
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.
Biospecimen Collection
Undergo optional blood sample collection
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Paclitaxel
Given IV
Questionnaire Administration
Ancillary studies
Ramucirumab
Given IV
Interventions
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Biospecimen Collection
Undergo optional blood sample collection
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Paclitaxel
Given IV
Questionnaire Administration
Ancillary studies
Ramucirumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Anwaar Saeed
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Baptist Health Medical Center - Little Rock
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Kaiser Permanente Dublin
Dublin, California, United States
Kaiser Permanente-Fontana
Fontana, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Kaiser Permanente South Bay
Harbor City, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Keck Medicine of USC Koreatown
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Kaiser Permanente West Los Angeles
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Kaiser Permanente-Ontario
Ontario, California, United States
Kaiser Permanente - Panorama City
Panorama City, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Kaiser Permanente Downtown Commons
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Marcos
San Marcos, California, United States
Kaiser San Rafael-Gallinas
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Memorial Hospital North
Colorado Springs, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
UCHealth Greeley Hospital
Greeley, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
AdventHealth Orlando
Orlando, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Emory Johns Creek Hospital
Johns Creek, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
Advocate Outpatient Center - Aurora
Aurora, Illinois, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Swedish Covenant Hospital
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Advocate Sherman Hospital
Elgin, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
AMG Libertyville - Oncology
Libertyville, Illinois, United States
Condell Memorial Hospital
Libertyville, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Mercyhealth Cancer Institute - Rockford
Rockford, Illinois, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, United States
Memorial Hospital East
Shiloh, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
Northwest Cancer Center - Main Campus
Crown Point, Indiana, United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana, United States
Northwest Oncology LLC
Dyer, Indiana, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, United States
Saint Mary Medical Center
Hobart, Indiana, United States
Saint Catherine Hospital
Indianapolis, Indiana, United States
The Community Hospital
Munster, Indiana, United States
Women's Diagnostic Center - Munster
Munster, Indiana, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States
Saint Anthony Regional Hospital
Carroll, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States
Broadlawns Medical Center
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States
HaysMed
Hays, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
Saint Joseph Hospital East
Lexington, Kentucky, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
UPMC Western Maryland
Cumberland, Maryland, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Henry Ford Health Providence Novi Hospital
Novi, Michigan, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, United States
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
University of Rochester
Rochester, New York, United States
Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
Cone Health Cancer Center at Asheboro
Asheboro, North Carolina, United States
Cone Health MedCenter Asheboro
Asheboro, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Premier Blood and Cancer Center
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Integris Southwest Medical Center
Oklahoma City, Oklahoma, United States
Integris Cancer Institute of Oklahoma
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States
Community Medical Center
Scranton, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Farmington Health Center
Farmington, Utah, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Duluth Clinic Ashland
Ashland, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
William S Middleton VA Medical Center
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States
Aspirus Medford Hospital
Medford, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States
Sheboygan Physicians Group
Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, United States
Countries
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Facility Contacts
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References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2023-11064
Identifier Type: REGISTRY
Identifier Source: secondary_id
S2303
Identifier Type: OTHER
Identifier Source: secondary_id
S2303
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2023-11064
Identifier Type: -
Identifier Source: org_study_id