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

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Trial Identification

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

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

Study ID: NCT01708941

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. Test the hypothesis that the combination of ipilimumab and high-dose interferon-alpha 2b (HDI \[recombinant interferon alfa-2b\]) will improve progression free survival (PFS) of patients with advanced metastatic melanoma as compared to ipilimumab alone (across ipilimumab treatment status). SECONDARY OBJECTIVES: I. Test the hypothesis that the combination of ipilimumab and HDI will prove to be safe and tolerable. II. Within the constraints of the sample size, attempt to test the hypotheses that (1) ipilimumab 10 mg/kg will lead to improved PFS in comparison to ipilimumab 3 mg/kg (across HDI treatment status); (2) the combination of ipilimumab and HDI will improve overall survival (OS) of patients with advanced metastatic melanoma as compared to ipilimumab alone (across ipilimumab treatment status) and (3) ipilimumab 10 mg/kg will lead to improved OS in comparison to ipilimumab 3 mg/kg (across HDI treatment status). OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM A: INDUCTION PHASE: Patients receive higher dose ipilimumab intravenously (IV) over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then subcutaneously (SC) 3 times weekly for 8 weeks. MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks. ARM B: INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses. MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24. ARM C: INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks. MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks. ARM D: INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses. MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 5 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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 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

Porter Adventist Hospital, Denver, Colorado, United States

Colorado Blood Cancer Institute, Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States

SCL Health Saint Joseph Hospital, 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

Littleton Adventist Hospital, Littleton, Colorado, United States

Sky Ridge Medical Center, Lone Tree, Colorado, United States

Longmont United Hospital, Longmont, Colorado, United States

Banner McKee Medical Center, Loveland, Colorado, United States

Parker Adventist Hospital, Parker, Colorado, United States

Rocky Mountain Cancer Centers-Parker, Parker, Colorado, United States

Saint Mary Corwin Medical Center, Pueblo, Colorado, United States

SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

Beebe Medical Center, Lewes, Delaware, United States

Christiana Gynecologic Oncology LLC, Newark, 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

Memorial Medical Center, 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

Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States

Iowa Methodist Medical Center, Des Moines, Iowa, United States

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

Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States

Mission Cancer and Blood - Laurel, 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

Beaumont Hospital - Dearborn, Dearborn, Michigan, United States

Ascension 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

Green Bay Oncology - Iron Mountain, Iron Mountain, 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

Ascension Saint Mary's Hospital, 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

Saint Francis Medical Center, Cape Girardeau, Missouri, United States

Southeast Cancer Center, Cape Girardeau, Missouri, United States

MU Health Care Goldschmidt Cancer Center, Jefferson City, Missouri, United States

Missouri Baptist Medical Center, Saint Louis, Missouri, United States

Sainte Genevieve County Memorial Hospital, Sainte Genevieve, 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, Omaha, Nebraska, United States

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

Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States

Nebraska Cancer Specialists - Omaha, Omaha, Nebraska, United States

Alegent Health Lakeside Hospital, Omaha, Nebraska, United States

Oncology Hematology West PC, Omaha, Nebraska, United States

Creighton University Medical Center, Omaha, Nebraska, United States

Regional West Medical Center Cancer Center, Scottsbluff, Nebraska, United States

Cooper Hospital University Medical Center, Camden, New Jersey, United States

Veterans Adminstration New Jersey Health Care System, East Orange, New Jersey, United States

Hunterdon Medical Center, Flemington, New Jersey, United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

New York Oncology Hematology PC - Albany Medical Center, Albany, New York, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

Summa Health System - Akron Campus, Akron, Ohio, United States

Strecker Cancer Center-Belpre, Belpre, Ohio, United States

Toledo Clinic Cancer Centers-Bowling Green, Bowling Green, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

MetroHealth Medical Center, Cleveland, Ohio, United States

Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Columbus NCI Community Oncology Research Program, Columbus, Ohio, United States

Grant Medical Center, Columbus, Ohio, United States

The Mark H Zangmeister Center, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Doctors Hospital, Columbus, Ohio, United States

Delaware Health Center-Grady Cancer Center, Delaware, Ohio, United States

Delaware Radiation Oncology, Delaware, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Lancaster Radiation Oncology, Lancaster, Ohio, United States

Lima Memorial Hospital, Lima, Ohio, United States

Marietta Memorial Hospital, Marietta, Ohio, United States

Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States

Knox Community Hospital, Mount Vernon, Ohio, United States

Licking Memorial Hospital, Newark, Ohio, United States

Newark Radiation Oncology, Newark, Ohio, United States

Saint Charles Hospital, Oregon, Ohio, United States

Toledo Clinic Cancer Centers-Oregon, Oregon, Ohio, United States

Southern Ohio Medical Center, Portsmouth, Ohio, United States

Springfield Regional Medical Center, Springfield, Ohio, United States

ProMedica Flower Hospital, Sylvania, Ohio, United States

Mercy Hospital of Tiffin, Tiffin, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States

Mercy Health - Saint Vincent Hospital, Toledo, Ohio, United States

University of Toledo, Toledo, Ohio, United States

Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio, United States

Mercy Health - Saint Anne Hospital, Toledo, Ohio, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States

Fulton County Health Center, Wauseon, Ohio, United States

Saint Ann's Hospital, Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States

Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States

Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States

Lewistown Hospital, Lewistown, Pennsylvania, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

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

Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States

Geisinger Medical Group, State College, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States

Erlanger Medical Center, Chattanooga, Tennessee, United States

Fredericksburg Oncology Inc, Fredericksburg, Virginia, United States

West Virginia University Charleston Division, Charleston, West Virginia, United States

Aurora Cancer Care-Southern Lakes VLCC, Burlington, Wisconsin, United States

Aurora Health Center-Fond du Lac, Fond Du Lac, Wisconsin, United States

Aurora Health Care Germantown Health Center, Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton, Grafton, Wisconsin, United States

Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States

Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States

Aurora BayCare Medical Center, Green Bay, Wisconsin, United States

University of Wisconsin Carbone Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States

Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, United States

Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States

Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States

Aurora Bay Area Medical Group-Marinette, Marinette, Wisconsin, United States

Bay Area Medical Center, Marinette, Wisconsin, United States

Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin, United States

Ascension Southeast Wisconsin Hospital - Saint Joseph Campus, Milwaukee, Wisconsin, United States

Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States

Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine, Racine, Wisconsin, United States

HSHS Saint Nicholas Hospital, Sheboygan, Wisconsin, United States

Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, United States

Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States

Aurora Medical Center in Summit, Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, United States

Aurora Cancer Care-Waukesha, Waukesha, Wisconsin, United States

Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, United States

Aurora West Allis Medical Center, West Allis, Wisconsin, United States

Contact Details

Name: Ahmad Tarhini

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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