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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01134614
Other study ID # NCI-2011-02039
Secondary ID NCI-2011-02039CD
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 28, 2010
Est. completion date March 8, 2025

Study information

Verified date March 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.


Description:

PRIMARY OBJECTIVES: I. To evaluate the overall survival for the combination of sargramostim (GM-CSF) plus ipilimumab and ipilimumab alone in patients with advanced melanoma. SECONDARY OBJECTIVES: I. To evaluate the progression-free survival, response rate, safety and tolerability for the combination of GM-CSF plus ipilimumab and ipilimumab alone in patients with advanced melanoma. II. To explore the utility of immune related response criteria (irRC) prospectively in patients receiving ipilimumab. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients 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. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity. ARM B: Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 245
Est. completion date March 8, 2025
Est. primary completion date February 15, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting - Histologic diagnosis of metastatic melanoma; for unknown primary disease, diagnosis of metastatic disease by cytology fine needle aspiration (FNA) is not acceptable - Women must not be pregnant or breast-feeding due to unknown effects of ipilimumab and GM-CSF on the unborn fetus; all women of childbearing potential must have a blood test within 72 hours prior to randomization to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception; women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential - White blood cells (WBC) >= 2000/uL (obtained =< 4 weeks prior to randomization) - Absolute neutrophil count (ANC) >= 1500/mcL (obtained =< 4 weeks prior to randomization) - Platelets >= 100,000/mcL (obtained =< 4 weeks prior to randomization) - Hemoglobin >= 8 g/dL (obtained =< 4 weeks prior to randomization) - Creatinine =< 3.0 x upper limit of normal (ULN) (obtained =< 4 weeks prior to randomization) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (obtained =< 4 weeks prior to randomization) - Bilirubin =< 3.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) (obtained =< 4 weeks prior to randomization) - No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids; must have been discontinued >= 4 weeks - No infection with human immunodeficiency virus (HIV); due to the mechanism of action of ipilimumab and GM-CSF, activity and side effects in an immune compromised patient are unknown - No active infection with hepatitis B - No active or chronic infection with hepatitis C - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: - Patients with any history of central nervous system (CNS) metastases are excluded - Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix - Patients are excluded if they have a history of any autoimmune disease; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy - Patients are excluded for any underlying medical or psychiatric condition, which 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 - Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to four weeks (28 days) prior to or after any dose of ipilimumab - Patients are excluded if they have a history of prior treatment with ipilimumab or prior cluster of differentiation (CD)137 agonist or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor or agonist - Any concurrent medical condition requiring the use of systemic steroids is not permitted (the use of inhaled or topical steroids is permitted)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Ipilimumab
Given IV
Sargramostim
Given SC

Locations

Country Name City State
United States Jefferson Abington Hospital Abington Pennsylvania
United States Summa Health System - Akron Campus Akron Ohio
United States New York Oncology Hematology PC - Albany Medical Center Albany New York
United States Presbyterian Kaseman Hospital Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States McFarland Clinic - Ames Ames Iowa
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 Langlade Hospital and Cancer Center Antigo Wisconsin
United States ThedaCare Regional Cancer Center Appleton Wisconsin
United States University Cancer and Blood Center LLC Athens Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States MacNeal Hospital and Cancer Center Berwyn Illinois
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States OSF Saint Joseph Medical Center Bloomington Illinois
United States Boca Raton Regional Hospital Boca Raton Florida
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Fairview Ridges Hospital Burnsville Minnesota
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Health Foundation Canton Ohio
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Graham Hospital Association Canton Illinois
United States Memorial Hospital Carthage Illinois
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States West Virginia University Charleston Division Charleston West Virginia
United States University of Virginia Cancer Center Charlottesville Virginia
United States Erlanger Medical Center Chattanooga Tennessee
United States Hematology and Oncology Associates Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States The Christ Hospital Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Mercy Hospital Coon Rapids Minnesota
United States Mary Imogene Bassett Hospital Cooperstown New York
United States Ochsner Health Center-Covington Covington Louisiana
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Decatur Memorial Hospital Decatur Illinois
United States Heartland Cancer Research NCORP Decatur Illinois
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Western States Cancer Research NCORP Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Mercy Medical Center - Des Moines 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 Ascension Saint John Hospital Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Doylestown Hospital Doylestown Pennsylvania
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart General Hospital Elkhart Indiana
United States Christiana Care - Union Hospital Elkton Maryland
United States Swedish Medical Center Englewood Colorado
United States Eureka Hospital Eureka Illinois
United States Sanford Broadway Medical Center Fargo North Dakota
United States San Juan Oncology Associates Farmington New Mexico
United States Hunterdon Medical Center Flemington New Jersey
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Poudre Valley Hospital Fort Collins Colorado
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Banner North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Hackensack University Medical Center Hackensack New Jersey
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Mason District Hospital Havana Illinois
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois
United States Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Allegiance Health Jackson Michigan
United States Jackson-Madison County General Hospital Jackson Tennessee
United States Mercyhealth Hospital and Cancer Center - Janesville Janesville Wisconsin
United States University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek Wisconsin
United States Duly Health and Care Joliet Joliet Illinois
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Presence Saint Mary's Hospital Kankakee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States IU Health La Porte Hospital La Porte Indiana
United States Lakeland Regional Health Hollis Cancer Center Lakeland Florida
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Mary Medical and Regional Cancer Center Langhorne Pennsylvania
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Nevada Cancer Institute-Summerlin Campus Las Vegas Nevada
United States Nevada Cancer Research Foundation NCORP Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States AMG Libertyville - Oncology Libertyville Illinois
United States Saint Rita's Medical Center Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
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 Mcdonough District Hospital Macomb Illinois
United States SSM Health Dean Medical Group - South Madison Campus Madison Wisconsin
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States Manchester Memorial Hospital Manchester Connecticut
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Bay Area Medical Center Marinette Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Trinity Medical Center Moline Illinois
United States West Virginia University Healthcare Morgantown West Virginia
United States Morristown Medical Center Morristown New Jersey
United States Virtua Memorial Mount Holly New Jersey
United States IU Health Ball Memorial Hospital Muncie Indiana
United States DuPage Medical Group-Ogden Naperville Illinois
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States The Hospital of Central Connecticut New Britain Connecticut
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Cancer Center of Kansas - Newton Newton Kansas
United States Illinois Cancer Specialists-Niles Niles Illinois
United States Bromenn Regional Medical Center Normal Illinois
United States Carle Cancer Institute Normal Normal Illinois
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States 21st Century Oncology-Orange Park Orange Park Florida
United States Saint Charles Hospital Oregon Ohio
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States VA Palo Alto Health Care System Palo Alto California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States OSF Saint Francis Radiation Oncology at Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Hospital Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Pottstown Hospital Pottstown Pennsylvania
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Perry Memorial Hospital Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Eisenhower Medical Center Rancho Mirage California
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Swedish American Hospital Rockford Illinois
United States UW Health Carbone Cancer Center Rockford Rockford Illinois
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
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 Cancer Center of Kansas - Salina Salina Kansas
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Hematology and Oncology Associates of North East Pennsylvania Scranton Pennsylvania
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Avera McKennan Hospital and University Health Center Sioux Falls South Dakota
United States Medical X-Ray Center Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Hematology Oncology Associates of Illinois - Skokie Skokie Illinois
United States Memorial Hospital of South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States Baystate Medical Center Springfield Massachusetts
United States Memorial Medical Center Springfield Illinois
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Stony Brook University Medical Center Stony Brook New York
United States Aurora Medical Center in Summit Summit Wisconsin
United States Overlook Hospital Summit New Jersey
United States ProMedica Flower Hospital Sylvania Ohio
United States North Suburban Medical Center Thornton Colorado
United States Mercy Health - Saint Vincent Hospital Toledo Ohio
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Reading Hospital West Reading Pennsylvania
United States Marshfield Medical Center - Weston Weston Wisconsin
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Lankenau Medical Center Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival Overall survival is defined as the time from randomization to death from any cause. Assessed every 3 months for 2 years, then every 6 months for 3 years
Secondary Progression-free Survival (PFS) Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Response and disease progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Disease progression is defined as >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression. Assessed every 3 months for 2 years, then every 6 months for 3 years
Secondary Proportion of Patients With Objective Response Objective response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial response (PR)= At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of partial response, changes in tumor measurements must be confirmed by a repeat assessment performed no less than four weeks after the criteria for response is met. Objective response = CR + PR. Assessed every 3 months for 2 years, then every 6 months for 3 years
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