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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01950390
Other study ID # NCI-2013-01732
Secondary ID NCI-2013-01732E3
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 24, 2014
Est. completion date January 7, 2025

Study information

Verified date March 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial studies how well ipilimumab with or without bevacizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.


Description:

PRIMARY OBJECTIVES: I. To compare overall survival for patients receiving ipilimumab plus bevacizumab versus ipilimumab alone. SECONDARY OBJECTIVES: I. To evaluate the progression free survival, response rate and safety in patients receiving ipilimumab plus bevacizumab versus ipilimumab alone. II. To evaluate the utility of immune related response criteria (irRC) in patients receiving ipilimumab plus bevacizumab versus ipilimumab alone. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: INDUCTION THERAPY: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning cycle 8, patients receive ipilimumab IV over 90 minutes on day 1. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. ARM B: INDUCTION THERAPY: Patients receive ipilimumab IV over 90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive bevacizumab as in Induction Therapy. Beginning cycle 8, patients also receive ipilimumab IV over 90 minutes on day 1. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 169
Est. completion date January 7, 2025
Est. primary completion date October 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 - Untreated or previously received one treatment regimen for measurable unresectable stage III or stage IV melanoma (American Joint Committee on Cancer [AJCC] 2010) (for BRAF wild-type, and regardless of human leukocyte antigen [HLA] type); untreated or previously received up to two treatment regimens for measurable unresectable stage III or stage IV melanoma (AJCC 2010) (for BRAF mutant, and regardless of HLA type; if 2 prior regimens, one should be a BRAF inhibitor); this does not include any therapies given in the adjuvant setting - Prior treatment (chemotherapy [chemo], radiation, hormone, and immune therapies) must be completed > 4 weeks prior to randomization (> 6 weeks prior to randomization for nitrosoureas, mitomycin C, and checkpoint inhibitors) - Patients who received prior therapy with anthracyclines should have a baseline multigated acquisition scan (MUGA) or echocardiogram (echo) with a normal ejection fraction within 28 days prior to randomization - Patients must have recovered from any acute toxicity associated with prior therapy by the start of study treatment - Women must not be pregnant or breast-feeding due to the unknown effects on the fetus or infant; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) - All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease - White blood cell (WBC) >= 2000/uL (obtained within 4 weeks prior to randomization) - Absolute neutrophil count (ANC) >= 1000/uL (obtained within 4 weeks prior to randomization) - Platelets >= 75 x 10^3/uL (obtained within 4 weeks prior to randomization) - Hemoglobin >= 9 g/dL (obtained within 4 weeks prior to randomization) - Creatinine =< 2.0 x upper limit of normal (ULN) (obtained within 4 weeks prior to randomization) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN for patients without liver metastases and =< 5 x ULN for patients with liver metastases (obtained within 4 weeks prior to randomization) - Serum bilirubin =< 2.0 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) (obtained within 4 weeks prior to randomization) - Patients BRAF mutation status must be known - No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids; must have been discontinued >= 4 weeks prior to randomization - No infection with human immunodeficiency virus (HIV); due to the mechanism of action of ipilimumab and bevacizumab, activity and side effects in an immune compromised patient are unknown - No active infection with hepatitis B - No active or chronic infection with hepatitis C - Women of childbearing potential and sexually active males must agree to practice abstinence or use an accepted and effective method of contraception Exclusion Criteria: - Patients are ineligible if they have any history of central nervous system (CNS) metastases - Patients are ineligible if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix - Patients are ineligible if they have a history of autoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy - Patients are ineligible if they have an active infection - Patients are ineligible if they have a history of prior treatment with ipilimumab, bevacizumab, or prior tumor CD137 agonist or CTLA-4 inhibitor or agonist; patients may be treatment naive or have had one prior systemic therapy for metastatic disease as outlined in the eligibility criteria; patients may have received PD-1 or PD-L1 as per current protocol eligibility, although they are not currently commercially approved in the front line setting - Patients are ineligible if they have a history of any underlying medical or psychiatric conditions or require any medications or treatment that in the opinion of the principal investigator may interfere with compliance, make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea - Patients are ineligible if they have any concurrent medical condition requiring the use of systemic steroids; (use of inhaled or topical steroids is acceptable) - Patients are ineligible if they have inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) - Patients are excluded if they have any prior history of hypertensive crisis or hypertensive encephalopathy - Patients are excluded if they have New York Heart Association (NYHA) grade II or greater congestive heart failure - Patients are excluded if they have a history of myocardial infarction or unstable angina within 6 months prior to randomization - Patients are excluded if they have a history of stroke or transient ischemic attack within 6 months prior to randomization - Patients are excluded if they have known significant vascular disease (e.g., aortic aneurysm, aortic dissection) - Patients are excluded if they have symptomatic peripheral vascular disease - Patients are excluded if they have evidence of bleeding diathesis or coagulopathy - Patients are excluded if they have had a surgical procedure or a significant traumatic injury within 28 days prior to randomization - Patients are excluded if they have had a biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to randomization - Patients are excluded if they have history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization - Patients are excluded if they have a non-healing wound or ulcer - Patients are excluded if they have proteinuria at screening as demonstrated by either: - Urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1 g of protein in 24 hours to be eligible) OR - Urine protein: creatinine (UPC) ratio >= 1.0 at screening; for UPC ratio > 1, a 24 hour urine protein should be obtained and the level should be < 1000 mg; NOTE: urine protein should be screened by urine analysis for UPC ratio; a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 g - Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - Patients are excluded if they have a history of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 3 months prior to randomization - Patients are excluded if they have current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin); subjects should have not taken full-dose warfarin or equivalent for at least 2 weeks prior to randomization - Patients are excluded if they have current or recent (within 10 days of enrollment) use of aspirin (> 325 mg/day) or chronic use of other non-steroidal anti-inflammatory drugs (NSAIDs) - Patients are excluded if they use medications that inhibit platelet function (e.g., dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and ibuprofen and related compounds) unless subject has been off treatment for at least 2 weeks prior to randomization - Patients are excluded if they have known involvement of melanoma within the gastrointestinal tract - Patients are excluded for any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Bevacizumab
Given IV
Ipilimumab
Given IV

Locations

Country Name City State
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Jefferson Abington Hospital Abington Pennsylvania
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Summa Health System - Akron Campus Akron Ohio
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
United States Kaiser Permanente-Anaheim Anaheim California
United States AnMed Health Cancer Center Anderson South Carolina
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Aultman Health Foundation Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Northwestern University Chicago Illinois
United States UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Oncology Hematology Care Inc-Anderson Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States Oncology Hematology Care Inc-Eden Park Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Oncology Hematology Care Inc-Mercy West Cincinnati Ohio
United States The Christ Hospital Cincinnati Ohio
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Case Western Reserve University Cleveland Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Mary Imogene Bassett Hospital Cooperstown New York
United States Mary Bird Perkins Cancer Center - Covington Covington Louisiana
United States Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Heartland Cancer Research NCORP Decatur Illinois
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Delaware Radiation Oncology Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Doylestown Hospital Doylestown Pennsylvania
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Walter Knox Memorial Hospital Emmett Idaho
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States JCHC McCreery Cancer Center Fairfield Iowa
United States Oncology Hematology Care Inc-Healthplex Fairfield Ohio
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center 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 Kaiser Permanente-Fontana Fontana California
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Bellin Memorial Hospital Green Bay Wisconsin
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Greenville Health System Cancer Institute-Andrews Greenville South Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Hackensack University Medical Center Hackensack New Jersey
United States Kaiser Permanente - Harbor City Harbor City California
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Hendersonville Hematology and Oncology at Pardee Hendersonville North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States AMITA Health Cancer Institute and Outpatient Center Hinsdale Illinois
United States Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Mary Bird Perkins Cancer Center - Houma Houma Louisiana
United States Cancer Center of Kansas-Independence Independence Kansas
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Kaiser Permanente-Irvine Irvine California
United States Allegiance Health Jackson Michigan
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States McFarland Clinic - Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States UW Cancer Center Johnson Creek Johnson Creek Wisconsin
United States Duly Health and Care Joliet Joliet Illinois
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Presence Saint Mary's Hospital Kankakee Illinois
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Vidant Oncology-Kinston Kinston North Carolina
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Lakeland Regional Health Hollis Cancer Center Lakeland Florida
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster General Hospital Lancaster Pennsylvania
United States Lancaster Radiation Oncology Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Nevada Cancer Research Foundation NCORP Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Beebe Medical Center Lewes Delaware
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States AMG Libertyville - Oncology Libertyville Illinois
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Lima Memorial Hospital Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Nebraska Hematology and Oncology Lincoln Nebraska
United States Southeast Nebraska Cancer Center - 68th Street Place Lincoln Nebraska
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente West Los Angeles Los Angeles California
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Norris Cotton Cancer Center-Manchester Manchester New Hampshire
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Marietta Memorial Hospital Marietta Ohio
United States OhioHealth Marion General Hospital Marion Ohio
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center Marshfield Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Riddle Memorial Hospital Media Pennsylvania
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Mount Sinai Medical Center Miami Beach Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Woodland Cancer Care Center Michigan City Indiana
United States Dayton Physicians LLC-Signal Point Middletown Ohio
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Hospital Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States University of South Alabama Mitchell Cancer Institute Mobile Alabama
United States Garneau, Stewart C MD (UIA Investigator) Moline Illinois
United States Porubcin, Michael MD (UIA Investigator) Moline Illinois
United States Spector, David MD (UIA Investigator) Moline Illinois
United States Trinity Medical Center Moline Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States West Virginia University Healthcare Morgantown West Virginia
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Inspira Medical Center Mullica Hill Mullica Hill New Jersey
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Dartmouth Cancer Center - Nashua Nashua New Hampshire
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Cancer Center of Kansas - Newton Newton Kansas
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Illinois Cancer Specialists-Niles Niles Illinois
United States Faith Regional Health Services Carson Cancer Center Norfolk Nebraska
United States Carle Cancer Institute Normal Normal Illinois
United States Great Plains Health Callahan Cancer Center North Platte Nebraska
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States Nebraska Cancer Specialists - Omaha Omaha Nebraska
United States Oncology Hematology West PC Omaha Nebraska
United States Urology Cancer Center PC Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Ottumwa Regional Health Center Ottumwa Iowa
United States Kaiser Permanente - Panorama City Panorama City California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Rapid City Regional Hospital Rapid City South Dakota
United States Corewell Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Saint Mary's Hospital Rhinelander Wisconsin
United States Lakeview Medical Center-Marshfield Clinic Rice Lake Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Reid Health Richmond Indiana
United States Kaiser Permanente-Riverside Riverside California
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States SwedishAmerican Regional Cancer Center/ACT Rockford Illinois
United States Penobscot Bay Medical Center Rockport Maine
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Cloud Hospital Saint Cloud Minnesota
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salem Hospital Salem Oregon
United States Cancer Center of Kansas - Salina Salina Kansas
United States Kaiser Permanente-San Diego Mission San Diego California
United States Kaiser Permanente-San Diego Zion San Diego California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Regional West Medical Center Cancer Center Scottsbluff Nebraska
United States Community Medical Center Scranton Pennsylvania
United States Scranton Hematology Oncology Scranton Pennsylvania
United States TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Welch Cancer Center Sheridan Wyoming
United States Dayton Physicians LLC-Wilson Sidney Ohio
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls 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 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois
United States North Shore Medical Center Skokie Illinois
United States Baystate Medical Center Springfield Massachusetts
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Stamford Hospital/Bennett Cancer Center Stamford Connecticut
United States Geisinger Medical Group State College Pennsylvania
United States Mount Nittany Medical Center State College Pennsylvania
United States Iredell Memorial Hospital Statesville North Carolina
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Southwest Illinois Health Services LLP Swansea Illinois
United States ProMedica Flower Hospital Sylvania Ohio
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Munson Medical Center Traverse City Michigan
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Inspira Medical Center Vineland Vineland New Jersey
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States MedStar Georgetown University Hospital Washington District of Columbia
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 Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Chester County Hospital West Chester Pennsylvania
United States Methodist West Hospital West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States Ascension Saint Clare's Hospital Weston Wisconsin
United States Diagnostic and Treatment Center Weston Wisconsin
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Dickstein Cancer Treatment Center White Plains New York
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Lankenau Medical Center Wynnewood Pennsylvania
United States University of Michigan Health - West Wyoming Michigan
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) OS distributions will be estimated using the Kaplan-Meier method. The distribution of OS will be compared using the stratified log rank test with one-sided overall type I error rate of 0.100 (adjusting for the one interim analysis) and the hazard ratio of OS will be estimated using the stratified Cox proportional hazard model and one-sided 90% repeated confidence interval will be constructed. Time from randomization to death from any cause, assessed up to 5 years
Secondary Progression-free Survival (PFS) Evaluated based on international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Will be estimated using the Kaplan-Meier method. PFS distributions will be compared using the log-rank test. Time from randomization to disease progression or death (whichever occurs first), assessed up to 5 years
Secondary Clinical Response Rate Clinical Response Rate is defined as the percentage of patients whose tumors have a complete response (CR) or partial response (PR) to treatment. Defined by Response Evaluation Criteria in Solid Tumors version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Up to 5 years
Secondary Incidence of Adverse Events (AE) Treatment-related grade 3-5 worst degree AEs rate. Defined using the Common Terminology Criteria for Adverse Events version 4.0 criteria (version 5.0 effective April 1,2018). Up to 90 days after completion of study treatment, up to 5 years post-registration.
Secondary Immune-related (ir) Responses Rate (Ir-CR+Ir-PR) Assessed using the utility of irRC. Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions (target and non-target together with no new measurable/unmeasurable lesions) for at least 4 weeks from the date of documentation of complete response. Immune-Related Partial Response (irPR): The sum of the products of the two largest perpendicular diameters of all target lesions is measured and captured as the SPD baseline. At each subsequent tumor assessment, the SPD of the two largest perpendicular diameters of all target lesions and of new measurable lesions are added together to provide the Immune Response Sum of Product Diameters (irSPD). A decrease, relative to baseline of the irSPD compared to the previous SPD baseline, of 50% or greater is considered an immune Partial Response (irPR). Up to 5 years
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