Melanoma of Unknown PrimaryPhase 3NCT01274338
Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
A Phase 3 study testing Ipilimumab, Quality-of-Life Assessment and Recombinant Interferon Alfa-2b in people with Melanoma of Unknown Primary and Recurrent Melanoma, run by National Cancer Institute (NCI) at 937 sites in 2 countries.
Trial summary
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Melanoma of Unknown Primary, Recurrent Melanoma, Stage IIIB Cutaneous Melanoma AJCC v7
- What is being tested?
- Ipilimumab, Quality-of-Life Assessment and Recombinant Interferon Alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,673 participants
- Where
- 937 sitesin 2 countries
- Study dates
- 17 Jun 2011to 2 Feb 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization; imaging studies must include a total body positron emission tomography (PET)-computed tomography (CT) scan (with or without brain) and brain magnetic resonance imaging (MRI) or CT (if MRI is contraindicated); if PET-CT cannot be done, CT of neck, chest, abdomen, and pelvis should be done
- If for some reason a CT cannot be done, an MRI may be done instead; any other imaging studies if performed (eg, bone scan) must show no evidence of disease
- Patients must have primary cutaneous melanoma that belong to one of the following American Joint Commission on Cancer (AJCC) stages (2009 AJCC Melanoma Staging System):
- Stage IIIB
- T1-4b N1a M0
- T1-4b N2a M0
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- T1-4b N1b M0
- T1-4b N2b M0
- T1-4b N2c M0
- Stage IIIC
- T1-4b N1b M0
- T1-4b N2b M0
- T1-4b N2c M0
- Any T N3 M0
- Stage IV
- M1a
- M1b
- NOTE: patients with stage IV melanoma must have normal lactate dehydrogenase (LDH) and either distant skin, subcutaneous, lymph node, or lung metastases, but no other visceral metastases in order to be eligible; for patients with resected stage IV melanoma, LDH within the institutional upper limit of normal (ULN) must be documented within 4 weeks prior to randomization
- Patients with disease recurrence after adequate surgical excision of the original primary cutaneous/unknown primary melanoma are allowed even if they don't fit the strict staging criteria, but only as follows:
- Recurrence in a regional lymph node basin after a prior complete lymph node dissection; relapsed disease must be completely surgically resected with free margins
- Recurrence in the form of in-transit or satellite metastases or distant skin/subcutaneous, nodal, or lung metastases that are completely surgically resected with free margins
- Recurrence in a regional lymph node basin; relapsed disease must be completely surgically resected with free margins
- Patients with unknown primary melanoma (Tx) who present with cutaneous, subcutaneous, nodal and/or lung metastases that are completely surgically resected with free margins are allowed; these patients are allowed even if they don't fit the strict staging criteria; for stage IV patients LDH within the institutional ULN must be documented within 4 weeks prior to randomization (M1c is not eligible)
- NOTE: all subjects should be classified as IIIB, IIIC, M1a or M1b including subjects with disease recurrence after adequate surgical excision of the original primary melanoma; that is the treating team/physician investigator should review an overall TNM status (that includes primary tumor presentation and disease recurrence status) and provide a designation of IIIB, IIIC, M1a or M1b
- Patients must be randomized within 84 days (12 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, the patient must be randomized within 12 weeks of the last surgery
- NOTE: patients with clinically positive lymph nodes for melanoma involvement or those with positive lymph nodes identified through lymphoscintigraphic and/or dye lymphographic techniques in the groin, axilla, or neck should have additional lymphadenectomy in those sites; the complete lymph node dissection procedure would be considered as the last surgery in counting the 84 days unless a subsequent surgical procedure(s) was clinically required to ensure the disease free status
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Given that serious adverse events may occur with ipilimumab and IFN-alpha and that these may impact a patient's wellbeing, it is possible that the occurrence of other serious adverse events (SAEs) may seriously impact an underlying state of mental depression and lead to suicidal ideation; therefore, patients should be carefully screened for depression at baseline and if there are indications or a history of depression it is strongly recommended that these patients be closely followed together with behavioral health or psychiatric medical support; patients with an established diagnosis of depression that, in the assessment of the investigator may make the administration of IFN-alpha or ipilimumab hazardous, should not be enrolled on this protocol; the risks and benefits of being treated with standard adjuvant IFN-alpha should be weighed very carefully in consultation with behavioral health or psychiatry
- Due to the possible effect of treatment with ipilimumab on the immunologic response to infectious disease vaccines, patients must not have had any infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, tetanus toxoid) within 4 weeks prior to randomization
- WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI, in such a manner that the risk of pregnancy is minimized; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
- Men of fathering potential and WOCBP must be using an adequate method of contraception to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible
- WOCBP are not eligible if they satisfy any of the following:
- A positive pregnancy test at baseline
- Pregnant or breastfeeding
- White blood cell (WBC) >= 3,000/uL (obtained within 4 weeks prior to randomization)
- Absolute neutrophil count (ANC) >= 1,500/uL (obtained within 4 weeks prior to randomization)
- Platelets >= 100 x 10^3/uL (obtained within 4 weeks prior to randomization)
- Hemoglobin >= 10 g/dL (obtained within 4 weeks prior to randomization)
- Serum creatinine =< 1.5 mg/dL (obtained within 4 weeks prior to randomization)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (obtained within 4 weeks prior to randomization)
- Serum bilirubin =< 1.5 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)
- No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C due to the unknown effects of ipilimumab; patients must have negative testing for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) within 4 weeks prior to randomization
Who cannot join
- Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial
- NOTE: previous radiation therapy, including after the surgical resection, is allowed as long as 21 days have elapsed between the radiation and initiation of this adjuvant systemic therapy
- Prior treatment with anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) monoclonal antibodies or prior CTLA-4 inhibitor or agonist or prior clusters of differentiation (CD)137 agonist or prior interferon-alfa is not allowed; other forms of prior treatment for melanoma (e.g., aldesleukin [IL-2], anti-tumor vaccine, chemotherapy) are allowed if given before the resection(s) that make(s) the patient eligible for this trial, but these must have been completed at least 4 weeks prior to randomization
- Patients must not have an active infection requiring current treatment with parenteral antibiotics
- Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients with a baseline of frequent diarrhea (e.g. irritable bowel syndrome) are not eligible because of the difficulty in interpreting later expected GI toxicities that may lead to suboptimal management and complications
- Patients must not have a documented history of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or diverticulitis (history of diverticulosis is allowed)
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- Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study
- Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis)
- Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
- Patients must not be prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness; this is due to concerns about subject safety and compliance with study procedures
- Patients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization; patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ are eligible; patients with prior history of basal or squamous skin cancer are eligible; patients who have had multiple primary melanomas are eligible
- Women must not be pregnant or breast-feeding due to the unknown effects of ipilimumab and HDI on conception and the fetus; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy
- NOTE: a woman of childbearing potential (WOCBP) is any woman, regardless of 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); post-menopause is defined as:
- Amenorrhea >= 12 consecutive months without another cause, or
- For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL
Trial locations and contacts
937 sites in 2 countries.
309 sites in 2 countries
United States300 sites
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Queen's Cancer Center - Pearlridge
‘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
Cleveland Clinic Akron General
Akron, Ohio, 44307
New York Oncology Hematology PC - Albany
Albany, New York, 12206
New York Oncology Hematology PC - Albany Medical Center
Albany, New York, 12208
Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina, 28002
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
AdventHealth Altamonte
Altamonte Springs, Florida, 32701
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic - Ames
Ames, Iowa, 50010
New York Oncology Hematology PC - Amsterdam
Amsterdam, New York, 12010
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
Alaska Regional Hospital
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
AnMed Health Cancer Center
Anderson, South Carolina, 29621
AnMed Health Hospital
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 Rogel Cancer Center
Ann Arbor, Michigan, 48109
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
PCR Oncology
Arroyo Grande, California, 93420
Randolph Hospital
Asheboro, North Carolina, 27203
Mission Hospital
Asheville, North Carolina, 28801
Mountain Radiation Oncology PA
Asheville, North Carolina, 28801
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803
Messino Cancer Centers
Asheville, North Carolina, 28806
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 28816
University Cancer and Blood Center LLC
Athens, Georgia, 30607
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Atlanta Regional CCOP
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
Sutter Auburn Faith Hospital
Auburn, California, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, 13021
MultiCare Auburn Medical Center
Auburn, Washington, 98001
Augusta University Medical Center
Augusta, Georgia, 30912
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
The Medical Center of Aurora
Aurora, Colorado, 80012
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Rush-Copley Medical Center
Aurora, Illinois, 60504
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Saint Agnes Hospital
Baltimore, Maryland, 21229
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237
Eastern Maine Medical Center
Bangor, Maine, 04401
Summa Health System - Barberton Campus
Barberton, Ohio, 44203
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809
Bronson Battle Creek
Battle Creek, Michigan, 49017
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, 44122
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107
Mary Rutan Hospital
Bellefontaine, Ohio, 43311
Overlake Medical Center
Bellevue, Washington, 98004
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Saint Charles Health System
Bend, Oregon, 97701
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Mac Neal Hospital
Berwyn, Illinois, 60402
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307
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
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
McFarland Clinic - Boone
Boone, Iowa, 50036
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Cox Cancer Center Branson
Branson, Missouri, 65616
Transylvania Regional Hospital
Brevard, North Carolina, 28712
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Saint Anne Hospital
Burien, Washington, 98166
Lahey Clinic
Burlington, Massachusetts, 01805
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, 13031
Graham Hospital Association
Canton, Illinois, 61520
Illinois CancerCare-Canton
Canton, Illinois, 61520
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
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Memorial Hospital
Carthage, Illinois, 62321
Rocky Mountain Oncology
Casper, Wyoming, 82609
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Miami Valley Hospital South
Centerville, Ohio, 45459
Centralia Oncology Clinic
Centralia, Illinois, 62801
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Roper Hospital
Charleston, South Carolina, 29401
Charleston Oncology - Roper
Charleston, South Carolina, 29403
Charleston Oncology - Saint Francis
Charleston, South Carolina, 29414
Lowcountry Oncology Associates - West Ashley
Charleston, South Carolina, 29414
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Memorial Hospital
Chattanooga, Tennessee, 37404
Hematology and Oncology Associates
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
Presence Resurrection Medical Center
Chicago, Illinois, 60631
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Weiss Memorial Hospital
Chicago, Illinois, 60640
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
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
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Oncology Hematology Care Inc-Anderson
Cincinnati, Ohio, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Bethesda North Hospital
Cincinnati, Ohio, 45242
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346
Case Western Reserve University
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
New York Oncology Hematology PC - Clifton Park
Clifton Park, New York, 12065
Sampson Radiation Oncology
Clinton, North Carolina, 28328
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Veterans Administration
Columbia, Missouri, 65201
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
John B Amos Cancer Center
Columbus, Georgia, 31904
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
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
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Mercy Hospital
Coon Rapids, Minnesota, 55433
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
Bay Area Hospital
Coos Bay, Oregon, 97420
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Ochsner Health Center-Covington
Covington, Louisiana, 70433
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017
Parkland Memorial Hospital
Dallas, Texas, 75235
Baylor University Medical Center
Dallas, Texas, 75246
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923
Carle at The Riverfront
Danville, Illinois, 61832
Geisinger Medical Center
Danville, Pennsylvania, 17822
Sutter Davis Hospital
Davis, California, 95616
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Miami Valley Hospital North
Dayton, Ohio, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459
AdventHealth Daytona Beach
Daytona Beach, Florida, 32117
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
Kaiser Permanente-Franklin
Denver, Colorado, 80205
AdventHealth Porter
Denver, Colorado, 80210
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Rose Medical Center
Denver, Colorado, 80220
Western States Cancer Research NCORP
Denver, Colorado, 80222
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
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 Hospital
Detroit, Michigan, 48202
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Mercy Medical Center
Durango, Colorado, 81301
Duke University Medical Center
Durham, North Carolina, 27710
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
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
Fairview Southdale Hospital
Edina, Minnesota, 55435
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Shaw Cancer Center
Edwards, Colorado, 81632
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
Advocate Sherman Hospital
Elgin, Illinois, 60123
Ascension Alexian Brothers - Elk Grove Village
Elk Grove Village, Illinois, 60007
Elkhart Clinic
Elkhart, Indiana, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Newman Regional Health
Emporia, Kansas, 66801
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Swedish Medical Center
Englewood, Colorado, 80113
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Eureka Hospital
Eureka, Illinois, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Providence Regional Cancer Partnership
Everett, Washington, 98201
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
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
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
Saint Francis Hospital
Federal Way, Washington, 98003
Blanchard Valley Hospital
Findlay, Ohio, 45840
Hunterdon Medical Center
Flemington, New Jersey, 08822
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
Singh and Arora Hematology Oncology PC
Flint, Michigan, 48532
Saint Agnes Hospital/Agnesian Cancer Center
Fond du Lac, Wisconsin, 54935
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, 54937
Poudre Valley Hospital
Fort Collins, Colorado, 80524
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845
Angel Medical Center
Franklin, North Carolina, 28734
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Frederick Memorial Hospital
Frederick, Maryland, 21701
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, 22408
Kaiser Permanente-Fremont
Fremont, California, 94538
Kaiser Permanente-Fresno
Fresno, California, 93720
Unity Hospital
Fridley, Minnesota, 55432
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Saint Jude Medical Center
Fullerton, California, 92835
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
Canada9 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1
Waterloo Regional Health Network
Kitchener, Ontario, N2G 1G3
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High Dose Interferon a-2b for Resected High Risk Melanoma
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive high-dose interferon alfa-2b (HDI) utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant).
II. To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant).
SECONDARY OBJECTIVES:
- To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP).
II. Among patients enrolled by Clinical Community Oncology programs (CCOPs), to compare the global quality of life (QOL) between the ipilimumab arms versus HDI using Functional Assessment of Cancer Therapy (FACT)-General (G) form and to evaluate the effect of treatment-related side effects that may have an impact on the health-related domains of QOL using Functional Assessment of Chronic Illness Therapy (FACIT)-diarrhea (D) and FACT-biological response modifiers (BRM).
OUTLINE: Patients age >= 18 are randomized to Arms A, B, or C and patients ages 12-17 are randomized to Arms D, E, or F.
ARM A: Patients receive induction high-dose ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (closed accrual as of 4/4/14) (adult accrual has completed to Arms A, B, and C as of 8/15/2014)
ARM B: Patients receive induction high-dose recombinant interferon alfa-2b IV over 20 minutes on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alfa-2b subcutaneously (SC) on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)
ARM C: Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)
ARM D: Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity.
ARM E: Patients receive induction high-dose recombinant interferon alfa-2b IV over 20 minutes on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alfa-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity
ARM F: Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to January 2026.
- Conditions
- Melanoma of Unknown Primary, Recurrent Melanoma, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
- Being tested
- Ipilimumab, Quality-of-Life Assessment, Recombinant Interferon Alfa-2b
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016
Given IV
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Recombinant Interferon Alfa-2bBiological
Also called Alfatronol, Bioferon, Bioferon (TM), Glucoferon
Given IV and SC
| Study group | Role | What they receive |
|---|---|---|
| Arm A (age >= 18, high-dose ipilimumab) | Experimental | Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (closed accrual as of 4/4/14) (adult accrual has completed to Arms A, B, and C as of 8/15/2014) Receives: Biological: Ipilimumab; Other: Quality-of-Life Assessment |
| Arm B (age >= 18, recombinant interferon alfa-2b) | Experimental | Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014) Receives: Other: Quality-of-Life Assessment; Biological: Recombinant Interferon Alfa-2b |
| Arm C (age >= 18, low-dose ipilimumab) | Experimental | Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cyclees in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014) Receives: Biological: Ipilimumab; Other: Quality-of-Life Assessment |
| Arm D (age 12-17, high-dose ipilimumab) | Experimental | Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. Receives: Biological: Ipilimumab |
| Arm E (ages 12-17, recombinant interferon alfa-2b) | Experimental | Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (ages 12-17) Receives: Biological: Recombinant Interferon Alfa-2b |
| Arm F (ages 12-17, low-dose ipilimumab) | Experimental | Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (ages 12-17) Receives: Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP])
Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence.
Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease.
Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease.
Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.
Measured: Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years
5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP])
Overall survival is defined as the time from randomization to death or date last known alive.
Measured: Assessed every 3 months for 2 years, then every 6 months for years 3-5
Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI])
Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence.
Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease.
Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease.
Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.
Measured: Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years
5-year Overall Survival (OS) Rate (Arm A [HIP] vs. Arm B [HDI])
Overall survival is defined as the time from randomization to death or date last known alive.
Measured: Assessed every 3 months for 2 years, then every 6 months for years 3-5
Secondary outcomes (3)
Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life. Change in FACT-G total score from baseline to 3 months was calculated as month 3 score - baseline score.
Measured: Assessed at baseline and 3 months
Change in FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months
The diarrhea subscale of The Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) is an 11-item questionnaire with a scale of 0-4. The FACIT-D diarrhea subscale score ranges between 0 and 44. The higher the score, the better the quality of life. Change in FACIT-D diarrhea subscale score from baseline to 3 months was calculated as month 3 score - baseline score.
Measured: Assessed at baseline and 3 months
Change in FACT-BRM (Functional Assessment of Cancer Therapy - Biologic Response Modifiers) Total Score From Baseline to 3 Months
The Functional Assessment of Cancer Therapy - Biologic Response Modifiers (FACT-BRM) is a questionnaire including FACT-G (The Functional Assessment of Cancer Therapy - General) and additional sections addressing physical and mental quality of life aspects. It is a 40-item questionnaire with a scale of 0-4. The FACT-BRM total score ranges between 0 and 160. The higher the score, the better the quality of life. Change in FACT-BRM total score from baseline to 3 months is calculated as month 3 score - baseline score.
Measured: Assessed at baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study start17 Jun 2011
- Primary completion15 Feb 2019
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Melanoma of Unknown PrimaryStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,673 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ahmad Tarhini, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274338
- Sponsor's protocol ID
- NCI-2011-02649
- Other IDs
- NCI-2011-02649, CDR0000692568, ECOG-E1609, E1609, E1609, E1609, P50CA121973, U10CA021115
- Status last verified
- Aug 2026
- First submitted
- 8 Jan 2011
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McLouth LE, Zheng Y, Smith S, Hodi FS, Rao UN, Cohen GI, Amatruda TT, Dakhil SR, Curti BD, Nakhoul I, Chandana SR, Bane CL, Marinier DE, Lee SJ, Sondak VK, Kirkwood JM, Tarhini AA, Wagner LI. Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III-IV melanoma in phase III trial E1609. Qual Life Res. 2023 Jan;32(1):183-196. doi: 10.1007/s11136-022-03226-8. Epub 2022 Aug 27.
PubMed 36029412Saad M, Lee SJ, Tan AC, El Naqa IM, Hodi FS, Butterfield LH, LaFramboise WA, Storkus W, Karunamurthy AD, Conejo-Garcia J, Hwu P, Streicher H, Sondak VK, Kirkwood JM, Tarhini AA. Enhanced immune activation within the tumor microenvironment and circulation of female high-risk melanoma patients and improved survival with adjuvant CTLA4 blockade compared to males. J Transl Med. 2022 Jun 3;20(1):253. doi: 10.1186/s12967-022-03450-3.
PubMed 35659704Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.
PubMed 25649350