Iris MelanomaPhase 3NCT01989572
Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery
A Phase 3 study testing Laboratory Biomarker Analysis, Sargramostim and Tyrosinase Peptide in people with Iris Melanoma and Medium/Large Size Posterior Uveal Melanoma, run by National Cancer Institute (NCI) at 148 sites in United States.
Trial summary
This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iris Melanoma, Medium/Large Size Posterior Uveal Melanoma, Mucosal Melanoma
- What is being tested?
- Laboratory Biomarker Analysis, Sargramostim and Tyrosinase Peptide
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 815 participants
- Where
- 148 sitesUnited States
- Study dates
- 23 Feb 2000to 31 Jan 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
148 sites in 1 country.
148 sites in 1 country
United States148 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
McFarland Clinic PC - Ames
Ames, Iowa, 50010
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Augusta University Medical Center
Augusta, Georgia, 30912
The Medical Center of Aurora
Aurora, Colorado, 80012
Rush - Copley Medical Center
Aurora, Illinois, 60504
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Eastern Maine Medical Center
Bangor, Maine, 04401
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
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
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boulder Community Hospital
Boulder, Colorado, 80301
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Aultman Health Foundation
Canton, Ohio, 44710
Medical University of South Carolina
Charleston, South Carolina, 29425
West Virginia University Charleston Division
Charleston, West Virginia, 25304
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219
Case Western Reserve University
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Medical City Dallas Hospital
Dallas, Texas, 75230
Geisinger Medical Center
Danville, Pennsylvania, 17822
Genesis Medical Center - East Campus
Davenport, Iowa, 52803
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45420
Atlanta VA Medical Center
Decatur, Georgia, 30033
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095
Swedish Medical Center
Englewood, Colorado, 80113
Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
Southwest Florida Regional Medical Center
Fort Myers, Florida, 33901
Aurora Cancer Care-Glendale
Glendale, Wisconsin, 53212
Glens Falls Hospital
Glens Falls, New York, 12801
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Franklin Medical Center
Greenfield, Massachusetts, 01301
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690
Hattiesburg Clinic - Hematology/Oncology Clinic
Hattiesburg, Mississippi, 39401
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
East Tennessee State University
Johnson City, Tennessee, 37614-0054
Jupiter Medical Center
Jupiter, Florida, 33458
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
University of Kansas Cancer Center
Kansas City, Kansas, 66160
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, 19047
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Medical Center of Central Georgia
Macon, Georgia, 31201
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Manchester Memorial Hospital
Manchester, Connecticut, 06040
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Loyola University Medical Center
Maywood, Illinois, 60153
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Orange Regional Medical Center
Middletown, New York, 10940
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Skagit Valley Hospital
Mount Vernon, Washington, 98274
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Creighton University Medical Center
Omaha, Nebraska, 68131
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Saint Joseph Hospital - Orange
Orange, California, 92868
AdventHealth Orlando
Orlando, Florida, 32803
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
VA Palo Alto Health Care System
Palo Alto, California, 94304
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Providence Portland Medical Center
Portland, Oregon, 97213
Pottstown Hospital
Pottstown, Pennsylvania, 19464
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Mayo Clinic
Rochester, Minnesota, 55905
Interlakes Foundation Inc-Rochester
Rochester, New York, 14623
University of Rochester
Rochester, New York, 14642
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Kaiser Permanente-San Diego Mission
San Diego, California, 92108
Naval Medical Center -San Diego
San Diego, California, 92134
Veterans Administration-San Diego Medical Center
San Diego, California, 92161
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Kaiser Permanente Washington
Seattle, Washington, 98112
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Memorial Medical Center
Springfield, Illinois, 62781
Baystate Medical Center
Springfield, Massachusetts, 01199
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141
Stony Brook University Medical Center
Stony Brook, New York, 11794
Montefiore Medical Center-Wakefield Campus
The Bronx, New York, 10466
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Saint John Medical Center
Tulsa, Oklahoma, 74104
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136
Carle Cancer Center
Urbana, Illinois, 61801
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, 31602
New York Medical College
Valhalla, New York, 10595
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Florida Cancer Specialists-West Palm Beach
West Palm Beach, Florida, 33401
Cleveland Clinic-Weston
Weston, Florida, 33331
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, 27104
About this study
Official title: A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare overall survival and disease-free survival of patients with completely resected stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or intransit lesions, treated with granulocyte macrophage colony-stimulating factor (GM-CSF) (sargramostim) vs. no GM-CSF, or other high risk patients listed in the eligibility section.
SECONDARY OBJECTIVES:
- To compare, using a 2 x 2 factorial design, overall survival and disease-free survival of human leukocyte antigen (HLA)-A2 positive patients treated with peptide vaccination vs. no peptide vaccination.
II. The following descriptive evaluations of survival and disease-free survival are planned for the HLA-A2 positive patients: (1) GM-CSF plus peptide vaccination vs. peptide vaccination alone; (2) GM-CSF plus peptide vaccination vs. GM-CSF alone; (3) GM-CSF plus peptide vaccination vs. placebo.
III. Survival and disease-free survival of HLA-A2 positive patients not receiving peptide vaccination will be compared to that of HLA-A2 negative patients not receiving peptide vaccination.
IV. To determine the influence of GM-CSF on circulating dendritic cell numbers and subpopulations in peripheral blood of patients receiving and not receiving GM-CSF.
- To determine, in HLA-A2 positive patients, whether immunization with peptides with or without GM-CSF elicits a measurable T-cell response as assessed by enzyme-linked immunosorbent spot (ELISPOT) and the major histocompatibility complex (MHC) tetramer assay, and to determine the functionality of these cells by intracellular cytokine staining.
OUTLINE: HLA-A2 positive patients are randomized to 1 of 4 treatment regimens (Arms I-IV). HLA-A2 negative patients are randomized to 1 of 2 treatment arms (Arms V-VI).
ARM I: Patients receive sargramostim subcutaneously (SC) on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
ARM II: Patients receive sargramostim placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
ARM III: Patients receive sargramostim SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
ARM IV: Patients receive sargramostim placebo SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
ARM V: Patients receive sargramostim SC on days 1-14.
ARM VI: Patients receive sargramostim placebo SC on days 1-14.
In all arms, treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
In the event of recurrence, patients who undergo complete resection of the recurrence may continue treatment for 6 courses or until completion of 1 year of therapy (whichever is longer). For patients with recurrence that is not surgically resectable or experiencing second recurrence, treatment will be discontinued.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 10 years.
- Conditions
- Iris Melanoma, Medium/Large Size Posterior Uveal Melanoma, Mucosal Melanoma, Ocular Melanoma With Extraocular Extension, Recurrent Melanoma, Recurrent Uveal Melanoma
- Being tested
- Laboratory Biomarker Analysis, Placebo, Sargramostim, Tyrosinase Peptide
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given GM-CSF placebo SC
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given peptide placebo SC
SargramostimBiological
Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine
Given SC
Tyrosinase PeptideBiological
Also called Tyrosinase Peptides
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Arm I (sargramostim, peptide vaccine) | Experimental | Patients receive sargramostim SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses). Receives: Other: Laboratory Biomarker Analysis; Biological: Sargramostim; Biological: Tyrosinase Peptide |
| Arm II (sargramostim placebo, peptide vaccine) | Experimental | Patients receive sargramostim placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses). Receives: Other: Laboratory Biomarker Analysis; Other: Placebo; Biological: Tyrosinase Peptide |
| Arm III (sargramostim, peptide placebo) | Experimental | Patients receive sargramostim SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses). Receives: Other: Laboratory Biomarker Analysis; Other: Placebo; Biological: Sargramostim |
| Arm IV (placebo, peptide placebo) | Placebo comparator | Patients receive placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses). Receives: Other: Laboratory Biomarker Analysis; Other: Placebo |
| Arm V (sargramostim) | Experimental | Patients receive sargramostim SC on days 1-14. Receives: Other: Laboratory Biomarker Analysis; Biological: Sargramostim |
| Arm VI (sargramostim placebo) | Placebo comparator | Patients receive sargramostim placebo SC on days 1-14. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as time from randomization to death from any cause.
Measured: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Recurrence Free Survival
Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Measured: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Secondary outcomes (4)
Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients
Overall survival is defined as time from randomization to death from any cause.
Measured: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15
Recurrence Free Survival in HLA-A2 Positive Patients
Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Measured: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
5-year Overall Survival Rate
Overall survival is defined as time from randomization to death from any cause, and 5-year overall survival rate is estimated via Kaplan-Meier method.
Measured: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
5-year Recurrence Free Survival Rate
Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events, and 5-year overall survival rate is estimated via Kaplan-Meier method. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Measured: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study start23 Feb 2000
- Primary completion8 Oct 2012
- Study completion31 Jan 2013
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 (1)Papers the sponsor has linked to this study.
- Other trials for Iris MelanomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David H Lawson, Principal investigator, Eastern Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989572
- Sponsor's protocol ID
- NCI-2013-02101
- Other IDs
- NCI-2013-02101, CALGB 500101, U10CA021115, ECOG-4697, CDR0000067568, SWOG-E4697, 9546, E4697
- Status last verified
- May 2026
- First submitted
- 18 Nov 2013
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lawson DH, Lee S, Zhao F, Tarhini AA, Margolin KA, Ernstoff MS, Atkins MB, Cohen GI, Whiteside TL, Butterfield LH, Kirkwood JM. Randomized, Placebo-Controlled, Phase III Trial of Yeast-Derived Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With No Evidence of Disease After Complete Surgical Resection of Locally Advanced and/or Stage IV Melanoma: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E4697). J Clin Oncol. 2015 Dec 1;33(34):4066-76. doi: 10.1200/JCO.2015.62.0500. Epub 2015 Sep 8.
PubMed 26351350