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A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Recurrent Melanoma, Stage III Melanoma, Stage IV Melanoma

Thank you

Trial Information

A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma


PRIMARY OBJECTIVES:

I. To evaluate the overall survival of patients with advanced melanoma treated with
ipilimumab with versus without sargramostim.

SECONDARY OBJECTIVES:

I. To evaluate the progression-free survival of patients treated with these regimens.

II. To evaluate the response rate in patients treated with these regimens. III. To evaluate
the safety and tolerability of these regimens in these patients.

IV. To explore prospectively the utility of immune-related response criteria (irRC) of
patients receiving ipilimumab.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage
(unresectable vs M1a/1b vs M1c) and prior therapy (none vs interferon vs one investigational
therapy). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1
and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21
days for 4 courses. Patients with responsive or stable disease then receive maintenance
therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on
days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim
repeats every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive induction therapy comprising ipilimumab as in arm I. Patients with
responsive or stable disease then receive maintenance therapy comprising ipilimumab IV as in
arm I. Courses repeat every 12 weeks in the absence of disease progression or unacceptable
toxicity.

After completion of study therapy, patients are followed up every 3-6 months for up to 5
years.


Inclusion Criteria:



- Histologically confirmed metastatic melanoma

- Unresectable stage III or IV disease

- For unknown primary disease, diagnosis of metastatic disease by cytology FNA is
not acceptable

- Measurable disease

- No more than 1 prior investigational therapy or systemic therapeutic regimen*,
including any of the following:

- Chemotherapy

- Biological therapy

- Biochemotherapy

- Investigational treatment

- No CNS metastases

- ECOG performance status 0-1

- WBC ≥ 2,000/μL

- ANC ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 8 g/dL

- Creatinine ≤ 3.0 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Bilirubin ≤ 3.0 times ULN (total bilirubin < 3.0 mg/dL for patients with Gilbert
syndrome)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 12 weeks after
completion of study

- No HIV infection

- No active infection with hepatitis B virus

- No active or chronic infection with hepatitis C virus

- No other malignancy with the past 2 years except adequately treated and cured basal
cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ
of the cervix

- No history of autoimmune disease, including any of the following:

- Inflammatory bowel disease

- Symptomatic disease (e.g., rheumatoid arthritis, systemic progressive
sclerosis[scleroderma])

- Systemic lupus erythematosus

- Autoimmune vasculitis (e.g., Wegener granulomatosis)

- Motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome
and myasthenia gravis)

- Patients with a history of autoimmune thyroiditis are eligible if their current
thyroid disorder is treated and stable with replacement or other medical therapy

- No underlying medical or psychiatric condition that, in the opinion of the
investigator, will make the administration of study drug hazardous or obscure the
interpretation of adverse events, such as a condition associated with frequent
diarrhea

- No concurrent medical condition requiring the use of systemic steroids

- No other concurrent CTLA-4 inhibitor or agonist or CD137 agonist

- At least 4 weeks since prior and no concurrent therapy with any of the following:

- Aldesleukin (IL-2)

- Interferon

- Non-study immunotherapy regimens

- Cytotoxic chemotherapy

- Immunosuppressive agents

- Other investigational therapies

- Chronic use of systemic corticosteroids

- Concurrent inhaled or topical steroids allowed

- Concurrent physiologic replacement doses of corticosteroids allowed

- No prior non-oncology vaccine therapy for the prevention of infectious disease within
the past 28 days or after any dose of ipilimumab

- No prior ipilimumab, CD137agonist, or CTLA-4 inhibitor or agonist

- No other systemic or local anticancer medications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

The method of Kaplan- Meir will be used.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Frank Hodi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02039

NCT ID:

NCT01134614

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage III Melanoma
  • Stage IV Melanoma
  • Melanoma

Name

Location

Akron City HospitalAkron, Ohio  44304
Johns Hopkins UniversityBaltimore, Maryland  21205
Cleveland Clinic FoundationCleveland, Ohio  44195
Abington Memorial HospitalAbington, Pennsylvania  19001
Hurley Medical CenterFlint, Michigan  48503
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
North Suburban Medical CenterThornton, Colorado  80229
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Marshfield ClinicMarshfield, Wisconsin  54449
Stanford UniversityStanford, California  94305
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Jackson-Madison County General HospitalJackson, Tennessee  38301
Rush University Medical CenterChicago, Illinois  60612-3824
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Overlook HospitalSummit, New Jersey  07902-0220
MetroHealth Medical CenterCleveland, Ohio  44109
Eisenhower Medical CenterRancho Mirage, California  92270
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Medical X-Ray CenterSioux Falls, South Dakota  57105
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Mercy Health SystemJanesville, Wisconsin  53545
Elkhart General HospitalElkhart, Indiana  46515
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Poudre Valley HospitalFort Collins, Colorado  80524
Memorial HospitalCarthage, Illinois  62321
Hematology and Oncology AssociatesChicago, Illinois  60611
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Mercy Medical CenterSpringfield, Ohio  45504
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Eureka HospitalEureka, Illinois  61530
Mercy HospitalCoon Rapids, Minnesota  55433
Graham Hospital AssociationCanton, Illinois  61520
Hematology Oncology Associates of Illinois-Highland ParkHighland Park, Illinois  60035
Saint Joseph Medical CenterJoliet, Illinois  60435
Trinity Medical CenterMoline, Illinois  61265-1291
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Mary Imogene Bassett HospitalCooperstown, New York  13326
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Lawrence Memorial HospitalLawrence, Kansas  66044
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
UW Cancer Center Johnson CreekJohnson Creek, Wisconsin  53038
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Longmont United HospitalLongmont, Colorado  80501
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Manchester Memorial HospitalManchester, Connecticut  06040-4188
Memorial Medical CenterSpringfield, Illinois  62781
Doylestown HospitalDoylestown, Pennsylvania  18901
University of VirginiaCharlottesville, Virginia  22908
University of PittsburghPittsburgh, Pennsylvania  15261
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Vanderbilt UniversityNashville, Tennessee  37232-6305
Northwestern UniversityChicago, Illinois  60611
Hennepin County Medical CenterMinneapolis, Minnesota  
VA Palo Alto Health Care SystemPalo Alto, California  94304-1207
Case Western Reserve UniversityCleveland, Ohio  44106
Yale UniversityNew Haven, Connecticut  06520
Emory UniversityAtlanta, Georgia  30322
Indiana University Medical CenterIndianapolis, Indiana  46202
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
Wichita CCOPWichita, Kansas  67214-3882
Flower HospitalSylvania, Ohio  43560-2197
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Lakeview HospitalStillwater, Minnesota  55082
Decatur Memorial HospitalDecatur, Illinois  62526
San Juan Oncology AssociatesFarmington, New Mexico  87401
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
OSF Saint Francis Medical CenterPeoria, Illinois  61637
The Medical Center of AuroraAurora, Colorado  80012
Penrose-Saint Francis HealthcareColorado Springs, Colorado  80907
Saint Anthony Central HospitalDenver, Colorado  80204
Exempla Saint Joseph HospitalDenver, Colorado  80218
Colorado Cancer Research Program CCOPDenver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado  81502
Saint Mary Corwin Medical CenterPueblo, Colorado  81004
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Saint Joseph's-Candler Health SystemSavannah, Georgia  31405
Rush - Copley Medical CenterAurora, Illinois  60504
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Provena Saint Mary's HospitalKankakee, Illinois  60901
North Shore Hematology OncologyLibertyville, Illinois  60048
Community Cancer Center FoundationNormal, Illinois  61761
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Hematology Oncology Associates of Illinois - SkokieSkokie, Illinois  60076
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
Saint Joseph's Medical CenterSouth Bend, Indiana  46617
McFarland ClinicAmes, Iowa  50010
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Siouxland Hematology - Oncology AssociatesSioux City, Iowa  51101
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Ochsner Clinic Foundation-Baton RougeBaton Rouge, Louisiana  70809
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Lakeland HospitalSt. Joseph, Michigan  49085
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Saint Mary's Medical CenterDuluth, Minnesota  55805
Miller-Dwan HospitalDuluth, Minnesota  55805
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Hunterdon Medical CenterFlemington, New Jersey  08822
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington CountyMount Holly, New Jersey  08060
Presbyterian Kaseman HospitalAlbuquerque, New Mexico  87110
New York University Langone Medical CenterNew York, New York  10016
Saint Rita's Medical CenterLima, Ohio  45801
Saint Charles HospitalOregon, Ohio  43616
The Toledo HospitalToledo, Ohio  43606
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Saint Luke's HospitalBethlehem, Pennsylvania  18015
Pottstown Memorial Medical CenterPottstown, Pennsylvania  19464
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center-Oncology ClinicSioux Falls, South Dakota  57104
Sanford University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Wheeling HospitalWheeling, West Virginia  26003
Langlade Hospital and Cancer CenterAntigo, Wisconsin  54409
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311-6519
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
Vince Lombardi Cancer Clinic-MarinetteMarinette, Wisconsin  54143
Bay Area Medical CenterMarinette, Wisconsin  54143
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake CenterRice Lake, Wisconsin  54868
Marshfield Clinic-Wausau CenterWausau, Wisconsin  54401
Aspirus Regional Cancer CenterWausau, Wisconsin  54401
Stony Brook University Medical CenterStony Brook, New York  11794
Northeast Georgia Cancer Care LLCAthens, Georgia  30607
DuPage Medical Group-OgdenNaperville, Illinois  60563
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Hackensack University Medical CCOPHackensack, New Jersey  07601
Erlanger Medical CenterChattanooga, Tennessee  37403
West Virginia University CharlestonCharleston, West Virginia  25304
Marshfield Clinic-Chippewa CenterChippewa Falls, Wisconsin  54729
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Vince Lombardi Cancer Clinic-SheboyganSheboygan, Wisconsin  53081
Marshfield Clinic Cancer Care at Saint Michael's HospitalStevens Point, Wisconsin  54481
Aurora Medical Center in SummitSummit, Wisconsin  53066
Vince Lombardi Cancer ClinicTwo Rivers, Wisconsin  54241
Hematology Oncology Associates-BerwynBerwyn, Illinois  60402
Ochsner North Shore Medical CenterCovington, Louisiana  70433
The Christ HospitalCincinnati, Ohio  45219
Gundersen LutheranLa Crosse, Wisconsin  54601
Saint Nicholas HospitalMadison, Wisconsin  53715
New York Oncology Hematology PC -Albany Medical CenterAlbany, New York  12208
Georgia Health Sciences UniversityAugusta, Georgia  30912
Boca Raton Regional HospitalBoca Raton, Florida  33486
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Oncology Associates at Mercy Medical CenterCedar Rapids, Iowa  52403
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Eastern Cooperative Oncology GroupBoston, Massachusetts  02215
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Illinois Cancer Specialists-NilesNiles, Illinois  60714
Cancer Specialists of North Florida-Orange ParkOrange Park, Florida  32073
Nevada Cancer Institute-Summerlin CampusLas Vegas, Nevada  89135