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ACTIVE NOT RECRUITING

NCT01708941

PHASE2

Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma.

Official title: A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination With High Dose Interferon-Alpha in Advanced Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2013-01-18

Completion Date

2026-03-19

Last Updated

2025-11-26

Healthy Volunteers

Conditions

Recurrent Melanoma Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7

Interventions

BIOLOGICAL

Ipilimumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Recombinant Interferon Alfa-2b

Given IV or SC

Inclusion Criteria: * Patients must have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin and that is histologically diagnosed * No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting; however, patients are excluded if they have a history of prior treatment for melanoma (either adjuvant or metastatic disease) with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, or prior interferon-alpha treatment for metastatic disease (history of adjuvant interferon-alpha is allowed); there should be a 4-week washout period between last treatment administration and initiation of study therapy * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * 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 must not have an active infection requiring current treatment with parenteral antibiotics * Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed) * 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; one exception are patients treated with a curative intent and are continuously disease free for \> 3 years; these patients would be considered eligible: * 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 Clark I melanoma in situ are eligible * Patients with prior history of basal or squamous skin cancer are eligible * 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 (e.g., 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 * 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 * Women must not be pregnant or breast-feeding; 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 sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 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); for the purposes of this study, post-menopause is defined as: * Amenorrhea \>= 24 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 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 or must abstain from sexual intercourse 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 * White blood cells (WBC) \>= 3000/uL * Absolute neutrophil count (ANC) \>= 1500/uL * Platelets \>= 100 x 10\^3/uL * Hemoglobin \>= 10 g/dL * Serum creatinine =\< 1.8 mg/dl * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) for patients with liver metastases and =\< 2.0 x ULN for patients without liver metastases * Serum bilirubin \< 2 x ULN for patients with liver metastases and =\< 1.5 x ULN for patients without liver metastases, (except patients with Gilbert's syndrome, who must have a total bilirubin \< 3.0 mg/dL) * No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Patients must be free of brain metastasis by contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) scans within 4 weeks prior to enrollment; if known to have prior brain metastases, must not have evidence of active brain disease after definitive therapy (surgery, radiation therapy or stereotactic radiosurgery) on two successive MRI evaluations at least 3 months apart (one of which is =\< 4 weeks prior to starting the study drugs) * All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

Locations (277)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Western States Cancer Research NCORP

Denver, Colorado, United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Rocky Mountain Cancer Centers-Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, United States

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Spector, David MD (UIA Investigator)

Moline, Illinois, United States

Trinity Medical Center

Moline, Illinois, United States

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

Illinois Cancer Specialists-Niles

Niles, Illinois, United States

Carle Cancer Institute Normal

Normal, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, United States

Proctor Hospital

Peoria, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Swedish American Hospital

Rockford, Illinois, United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Hematology Oncology Associates of Illinois - Skokie

Skokie, Illinois, United States

Central Illinois Hematology Oncology Center

Springfield, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

The Carle Foundation Hospital

Urbana, Illinois, United States

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

IU Health Central Indiana Cancer Centers-East

Indianapolis, Indiana, United States

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Woodland Cancer Care Center

Michigan City, Indiana, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

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

Clive, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Iowa Lutheran Hospital

Des Moines, Iowa, United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

Mercy Medical Center-Sioux City

Sioux City, Iowa, United States

Saint Luke's Regional Medical Center

Sioux City, Iowa, United States

Methodist West Hospital

West Des Moines, Iowa, United States

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Cancer Center of Kansas-Manhattan

Manhattan, Kansas, United States

Cancer Center of Kansas - McPherson

McPherson, Kansas, United States

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Associates In Womens Health

Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Ochsner Health Center-Summa

Baton Rouge, Louisiana, United States

Ochsner Baptist Medical Center

New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Christiana Care - Union Hospital

Elkton, Maryland, United States

Bixby Medical Center

Adrian, Michigan, United States

Hickman Cancer Center

Adrian, Michigan, United States

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

OSF Saint Francis Hospital and Medical Group

Escanaba, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Mercy Memorial Hospital

Monroe, Michigan, United States

Toledo Clinic Cancer Centers-Monroe

Monroe, Michigan, United States

Lake Huron Medical Center

Port Huron, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Hutchinson Area Health Care

Hutchinson, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Health Partners Inc

Minneapolis, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, United States

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Nebraska Hematology and Oncology

Lincoln, Nebraska, United States

Nebraska Cancer Research Center

Lincoln, Nebraska, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Missouri Valley Cancer Consortium