Can a vaccine keep melanoma from coming back? large trial tests immune boosters

NCT ID NCT01989572

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether a yeast-derived immune stimulant (GM-CSF) and a peptide vaccine, alone or together, could prevent melanoma from returning after surgery. 815 patients with no visible cancer after complete surgical removal of advanced melanoma were randomly assigned to receive GM-CSF, the vaccine, both, or placebo. The study measured how long patients lived without the cancer coming back and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Sargramostim (GM-CSF) and tyrosinase peptide vaccine
What this could lead to: If successful, this could show that combining GM-CSF with a peptide vaccine helps prevent melanoma from coming back after surgery.
What could go wrong: This trial is complete, but results may not show a clear benefit over placebo. The approach is complex and may not work for all melanoma types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

815 people

The number who actually took part.

Started

Feb 2000

Finished

Jan 2013

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have HLA-A2 status known prior to randomization; typing may be obtained through a local laboratory facility or through a reference lab utilized by the initiating institution; if typing is not available through these means, it may be obtained from the University of Pittsburgh * All patients must have disease completely resected with one of the following in order to be eligible: * Completely resected disease * Any locoregional recurrence after prior adjuvant interferon or failure on S008 * Any local recurrence of disease after adequate surgical excision of the original primary * Mucosal melanoma * Stage IV melanoma (cutaneous, ocular, mucosal, or unknown primary) * The following groups of patients may be entered onto this trial only if they are ineligible for S0008 or are, in the opinion of the managing physician, medically unfit to receive standard high-dose interferon: * Any clinically evident satellite or in-transit disease * Stage II disease with gross extracapsular extension * Recurrence in a previously resected nodal basin * Four or more involved lymph nodes or matted lymph nodes * Ulcerated primary melanoma and any involved lymph nodes * NOTE: Patients who are eligible for S0008 will be strongly encouraged to participate in that study in preference to this one * Patients must have been surgically rendered free of disease with negative margins on resected specimens; patients rendered free of disease by non-surgical means are not eligible * Patients must be randomized within 112 days (16 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, all required surgeries must be accomplished within this 16 week time period * 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; one systemic treatment after a prior surgery is allowed, and must have been completed \>= 8 weeks prior to randomization; (when chemotherapy and biotherapy are given together as one planned treatment \[biochemotherapy\], this counts as one regimen); NOTE: Previous radiation therapy, including after the resection, is allowed as long as 30 days elapse between the radiation and initiation of therapy * Prior treatment with GM-CSF or any peptides used in this protocol, is not allowed * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patients must not have an active infection requiring treatment with parenteral antibiotics * Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that may interfere with compliance on any of the E4697 treatment regimens * Patients must not have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol * Patients must be able to self-administer or arrange for administration of subcutaneous injections * Patients who have other current malignancies are not 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 who meet this criteria must be disease-free at time of randomization * Patients with prior history of basal or squamous skin cancer are eligible; patients who meet this criteria must be disease-free at time of randomization * Patients who have had multiple primary melanomas are eligible * Patients with other malignancies are eligible if they have been continuously disease free for \> 5 years prior to the time of randomization * Patients must not have autoimmune disorders, conditions of immunosuppression or treatment with systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone), continuous use of topical steroid creams or ointments, or any steroid containing inhalers; 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, the patient is not likely to require these classes of drugs during the study * Women of childbearing potential must not be pregnant (negative beta human chorionic gonadotropin \[bHCG\] within 2 weeks prior to randomization) or breast-feeding * Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment * All patients must have brain computed tomography (CT) or magnetic resonance imaging (MRI), chest CT or chest x-ray (CXR), and abdominal (liver) CT or MRI within 4 weeks prior to randomization; positron emission tomography (PET) scans are also acceptable in place of CT, CXR and/or abdominal MRI if obtained within 4 weeks prior to randomization; patients with lesions on the lower extremity must also have pelvic imaging within this time period; this is also strongly recommended for patients with lesions on the lower trunk; PET scans are acceptable * Patients with resection of visceral disease must have imaging of the affected area/organ documenting disease-free status within 2 weeks prior to randomization * White blood cells (WBC) \>= 3,000/mm? * Platelet count \>= 100,000/mm? * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2 x institutional upper limit (IUL) of normal * Bilirubin =\< 2 x IUL of normal * Serum creatinine =\< 1.8 mg/dl * Alkaline phosphatase and lactate dehydrogenase (LDH) must be performed within 4 weeks prior to randomization; LDH must be normal; patients with abnormal alkaline phosphatase which is =\< 1.25 times the institutional upper limit of normal who have a negative CT or MRI of the liver and negative bone scan or a negative PET scan are eligible * Patients with bone pain must have a bone scan within 4 weeks prior to randomization to document the absence of tumor

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Conditions

The condition(s) this trial relates to.

cancer of unknown primary site cutaneous melanoma iris melanoma medium/large size posterior uveal melanoma melanoma metastatic melanoma mucosal melanoma ocular melanoma ocular melanoma with extraocular extension small size posterior uveal melanoma uveal cancer uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Iris melanoma Medium/large size posterior uveal melanoma Mucosal melanoma Ocular melanoma with extraocular extension Recurrent melanoma Recurrent uveal melanoma Small size posterior uveal melanoma Stage IIA cutaneous melanoma ajcc V6 and V7 Stage IIA uveal melanoma ajcc V7 Stage IIB cutaneous melanoma ajcc V6 and V7 Stage IIB uveal melanoma ajcc V7 Stage IIC cutaneous melanoma ajcc V6 and V7 Stage IIIA cutaneous melanoma ajcc V7 Stage IIIA uveal melanoma ajcc V7 Stage IIIB cutaneous melanoma ajcc V7 Stage IIIB uveal melanoma ajcc V7 Stage IIIC cutaneous melanoma ajcc V7 Stage IIIC uveal melanoma ajcc V7 Stage IV cutaneous melanoma ajcc V6 and V7 Stage IV uveal melanoma ajcc V7

Contacts and locations

Locations

AdventHealth Orlando

Orlando, Florida, 32803, United States
Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States
Alegent Health Immanuel Medical Center

Omaha, Nebraska, 68122, United States
Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States
Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States
Atlanta VA Medical Center

Decatur, Georgia, 30033, United States
Augusta University Medical Center

Augusta, Georgia, 30912, United States
Aultman Health Foundation

Canton, Ohio, 44710, United States
Aurora Cancer Care-Glendale

Glendale, Wisconsin, 53212, United States
Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States
Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States
Baystate Medical Center

Springfield, Massachusetts, 01199, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Boulder Community Hospital

Boulder, Colorado, 80301, United States
CHI Health Saint Francis

Grand Island, Nebraska, 68803, United States
Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505, United States
Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, 49503, United States
Cancer Research for the Ozarks NCORP

Springfield, Missouri, 65804, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Cleveland Clinic-Weston

Weston, Florida, 33331, United States
Creighton University Medical Center

Omaha, Nebraska, 68131, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Dayton NCI Community Oncology Research Program

Dayton, Ohio, 45420, United States
Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
East Tennessee State University

Johnson City, Tennessee, 37614-0054, United States
Eastern Maine Medical Center

Bangor, Maine, 04401, United States
Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905-5650, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Florida Cancer Specialists-West Palm Beach

West Palm Beach, Florida, 33401, United States
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Franklin Medical Center

Greenfield, Massachusetts, 01301, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Genesis Medical Center - East Campus

Davenport, Iowa, 52803, United States
Glens Falls Hospital

Glens Falls, New York, 12801, United States
Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States
Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States
Hattiesburg Clinic - Hematology/Oncology Clinic

Hattiesburg, Mississippi, 39401, United States
Holy Family Memorial Hospital

Manitowoc, Wisconsin, 54221, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
IU Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States
IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States
Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Interlakes Foundation Inc-Rochester

Rochester, New York, 14623, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, 50309, United States
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Jupiter Medical Center

Jupiter, Florida, 33458, United States
Kaiser Permanente Washington

Seattle, Washington, 98112, United States
Kaiser Permanente-San Diego Mission

San Diego, California, 92108, United States
Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, 33805, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States
Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Manchester Memorial Hospital

Manchester, Connecticut, 06040, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States
McFarland Clinic PC - Ames

Ames, Iowa, 50010, United States
Medical Center of Central Georgia

Macon, Georgia, 31201, United States
Medical City Dallas Hospital

Dallas, Texas, 75230, United States
Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Medical Center

Springfield, Illinois, 62781, United States
MetroHealth Medical Center

Cleveland, Ohio, 44109, United States
Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States
Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States
Montana Cancer Consortium NCORP

Billings, Montana, 59102, United States
Montefiore Medical Center-Wakefield Campus

The Bronx, New York, 10466, United States
Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States
Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136, United States
Naval Medical Center -San Diego

San Diego, California, 92134, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, 89106, United States
New York Medical College

Valhalla, New York, 10595, United States
North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States
Northwestern University

Chicago, Illinois, 60611, United States
Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States
Ochsner Health Center-Summa

Baton Rouge, Louisiana, 70809, United States
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Orange Regional Medical Center

Middletown, New York, 10940, United States
Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States
Pottstown Hospital

Pottstown, Pennsylvania, 19464, United States
ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States
ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Rush - Copley Medical Center

Aurora, Illinois, 60504, United States
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States
SCL Health Saint Joseph Hospital

Denver, Colorado, 80218, United States
Saint John Medical Center

Tulsa, Oklahoma, 74104, United States
Saint Joseph Hospital - Orange

Orange, California, 92868, United States
Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, 63141, United States
Saint Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States
Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015, United States
Saint Mary Medical and Regional Cancer Center

Langhorne, Pennsylvania, 19047, United States
Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501, United States
Saint Vincent Healthcare

Billings, Montana, 59101, United States
Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States
Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States
Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States
Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States
South Georgia Medical Center/Pearlman Cancer Center

Valdosta, Georgia, 31602, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem, North Carolina, 27104, United States
Southwest Florida Regional Medical Center

Fort Myers, Florida, 33901, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
Stony Brook University Medical Center

Stony Brook, New York, 11794, United States
Swedish Medical Center

Englewood, Colorado, 80113, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122-4307, United States
The Cancer Institute of New Jersey Hamilton

Hamilton, New Jersey, 08690, United States
The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States
The Medical Center of Aurora

Aurora, Colorado, 80012, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States
University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Cincinnati/Barrett Cancer Center

Cincinnati, Ohio, 45219, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Missouri - Ellis Fischel

Columbia, Missouri, 65212, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States
University of Rochester

Rochester, New York, 14642, United States
University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States
University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States
VA Palo Alto Health Care System

Palo Alto, California, 94304, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Veterans Administration-San Diego Medical Center

San Diego, California, 92161, United States
Veterans Adminstration New Jersey Health Care System

East Orange, New Jersey, 07018-1095, United States
Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States
Wichita NCI Community Oncology Research Program

Wichita, Kansas, 67214, United States

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