AzTrials
AzTrials

Stage IIIC Cutaneous Melanoma AJCC v7Phase 2NCT01950390

Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

A Phase 2 study testing Bevacizumab and Ipilimumab in people with Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IV Cutaneous Melanoma AJCC v6 and v7, run by National Cancer Institute (NCI) at 482 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
482 sitesUnited States
Study dates
24 Jan 2014to 31 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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)
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  • 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
  • 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)
  • Women of childbearing potential and sexually active males must agree to practice abstinence or use an accepted and effective method of contraception

Who cannot join

None listed.

Trial locations and contacts

482 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Hematology Oncology Associates of Central New York-Auburn

    Auburn, New York, 13021

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Hematology Oncology Associates of CNY at Camillus

    Camillus, New York, 13031

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Caro Cancer Center

    Caro, Michigan, 48723

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Oncology Hematology Care Inc-Eden Park

    Cincinnati, Ohio, 45202

  • Oncology Hematology Care Inc-Mercy West

    Cincinnati, Ohio, 45211

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care Inc-Anderson

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Oncology Hematology Care Inc-Blue Ash

    Cincinnati, Ohio, 45242

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

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

    Clive, Iowa, 50325

  • Big Horn Basin Cancer Center

    Cody, Wyoming, 82414

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Mary Bird Perkins Cancer Center - Covington

    Covington, Louisiana, 70433

  • Oncology Hematology Care Inc-Crestview

    Crestview Hills, Kentucky, 41017

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

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

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • JCHC McCreery Cancer Center

    Fairfield, Iowa, 52556

  • Oncology Hematology Care Inc-Healthplex

    Fairfield, Ohio, 45014

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Kaiser Permanente South Bay

    Harbor City, California, 90710

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Oncology Las Vegas - Henderson

    Henderson, Nevada, 89074

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hematology Oncology Associates of Illinois-Highland Park

    Highland Park, Illinois, 60035

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • UChicago Medicine AdventHealth Cancer Institute Hinsdale

    Hinsdale, Illinois, 60521

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Mary Bird Perkins Cancer Center - Houma

    Houma, Louisiana, 70360

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Allegiance Health

    Jackson, Michigan, 49201

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Duly Health and Care Joliet

    Joliet, Illinois, 60435

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • ECU Health Oncology Kinston

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Lakeland Regional Health Hollis Cancer Center

    Lakeland, Florida, 33805

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster Radiation Oncology

    Lancaster, Ohio, 43130

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Nevada Cancer Research Foundation NCORP

    Las Vegas, Nevada, 89120

  • Cancer Therapy and Integrative Medicine

    Las Vegas, Nevada, 89121

  • Cancer and Blood Specialists-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • Oncology Las Vegas - Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    Las Vegas, Nevada, 89149

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Nebraska Hematology and Oncology

    Lincoln, Nebraska, 68506

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Dartmouth Cancer Center - Manchester

    Manchester, New Hampshire, 03102

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Marshfield Medical Center

    Marshfield, Wisconsin, 54449

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

    Maumee, Ohio, 43537

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Woodland Cancer Care Center

    Michigan City, Indiana, 46360

  • Dayton Physicians LLC-Signal Point

    Middletown, Ohio, 45042

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Center

    Missoula, Montana, 59804

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36688

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael MD (UIA Investigator)

    Moline, Illinois, 61265

  • Spector, David MD (UIA Investigator)

    Moline, Illinois, 61265

  • Trinity Medical Center

    Moline, Illinois, 61265

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • Mercy Memorial Hospital

    Monroe, Michigan, 48162

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Ipilimumab With or Without Bevacizumab in Patients With Unresectable Stage III or Stage IV Melanoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare overall survival for patients receiving ipilimumab plus bevacizumab versus ipilimumab alone.

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Bevacizumab, Ipilimumab
Medical subject headings
Melanoma

What participants receive

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

  • BevacizumabBiological

    Also called ABP 215, ABP-215, ABP215, Alymsys

    Given IV

  • IpilimumabBiological

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

    Given IV

Study groups in NCT01950390
Study groupRoleWhat they receive
Arm A (ipilimumab)Active comparatorINDUCTION THERAPY: Patients receive ipilimumab 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.
Receives: Biological: Ipilimumab
Arm B (ipilimumab and bevacizumab)ExperimentalINDUCTION 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.
Receives: Biological: Bevacizumab; Biological: Ipilimumab

What is being measured

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

  1. 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.

    Measured: Time from randomization to death from any cause, assessed up to 5 years

Secondary outcomes (4)

  1. 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.

    Measured: Time from randomization to disease progression or death (whichever occurs first), assessed up to 5 years

  2. 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.

    Measured: Up to 5 years

  3. 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).

    Measured: Up to 90 days after completion of study treatment, up to 5 years post-registration.

  4. 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).

    Measured: Up to 5 years

Timeline

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

  1. First posted25 Sep 2013 (estimated)
  2. Study start24 Jan 2014
  3. Primary completion6 Oct 2021
  4. Study completion31 Jan 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01950390
Sponsor's protocol ID
NCI-2013-01732
Other IDs
NCI-2013-01732, E3612, ECOG-E3612, E3612, E3612, U10CA021115, U10CA180820, U24CA196172
Status last verified
Nov 2025
First submitted
23 Sep 2013
Last updated
11 Dec 2025
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Ipilimumab in people with Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IV Cutaneous Melanoma AJCC v6 and v7, run by National Cancer Institute (NCI) at 482 sites in United States.

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

Who may be eligible to take part?

The sponsor lists 49 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 482 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Time from randomization to death from any cause, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01950390.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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