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| ID | Type | Description | Link |
|---|---|---|---|
| CA184-002 | Other Identifier | BMS |
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The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.
Melanoma accounts for approximately 5% of all skin cancers in the United States, but it accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic melanoma). First line treatments for metastatic melanoma, usually IL-2, dacarbazine and/or temozolomide, are associated with significant toxicities. MDX-010 (anti-CTLA4) antibodies are designed to keep the immune system running by blocking CTLA-4 from down-regulating T cell activation. MDX-1379 is made up of two peptides that are pieces of a bigger melanoma protein (gp100). These peptides bind to HLA-A2 which is then recognized by T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo |
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| 2 | Experimental | MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine) |
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| 3 | Active Comparator | MDX-010 (ipilimumab) + Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDX-010 (anti-CTLA4) monoclonal antibody | Drug | 3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone | OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy | OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26700304 | Derived | Larkin J, Hatswell AJ, Nathan P, Lebmeier M, Lee D. The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK. PLoS One. 2015 Dec 23;10(12):e0145524. doi: 10.1371/journal.pone.0145524. eCollection 2015. | |
| 26627641 | Derived | Koguchi Y, Hoen HM, Bambina SA, Rynning MD, Fuerstenberg RK, Curti BD, Urba WJ, Milburn C, Bahjat FR, Korman AJ, Bahjat KS. Serum Immunoregulatory Proteins as Predictors of Overall Survival of Metastatic Melanoma Patients Treated with Ipilimumab. Cancer Res. 2015 Dec 1;75(23):5084-92. doi: 10.1158/0008-5472.CAN-15-2303. |
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Of the 1783 participants who enrolled and were screened for study participation, a total of 676 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipilimumab Plus gp100 | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| MDX-1379 (gp100) Melanoma Peptide Vaccine | Biological | 2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses. |
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| From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) |
| 12-, 18-, and 24-Month Survival Rates | The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials. | Month 12, Month 18, Month 24 |
| Progression Free Survival (PFS) | PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) |
| Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24 | PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. | Week 12, Week 24 |
| Time to Progression (TTP) | TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death. | from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks]) |
| Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD) | Investigator's assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations >=4 weeks apart, no evidence of PD. PR: >=50% ↓ in sum of products of longest diameter & greatest perpendicular diameter of all target lesions compared to baseline by 2 observations >=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ >=25% in sum of products of longest diameter & greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of >= 1 new lesion. | BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1. |
| Determination of Best Overall Response Rate (BORR) | Response was based on the investigators' assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated. | Up to week 24 |
| Time to Response | Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator. | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) |
| Duration of Response | Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first). | from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) |
| Disease Control Rate (DCR) | Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group. | Up to week 24 |
| Delayed Response (Response Beyond Week 24) | Response was based on the investigators' assessment using modified World Health Organization (WHO) criteria. Delayed response is defined as post Week 24 overall response for the subjects who have PD before or at Week 24. Evaluation of delayed overall response is compared to baseline assessment. Delayed response includes delayed late CR, delayed late PR, delayed late SD, continued PD, unknown, and missing after Week 24. The delayed response of CR and PR also must have been confirmed. | from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) |
| Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12 | The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe). | Baseline (Day 1, Cycle1), Week 12 |
| Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death | An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used. | On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
| Percentage of Participants With Immune-Related Adverse Events (irAEs) | An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of "Other irAEs" includes blood, eye, immune, infections, renal, and respiratory systems. | On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
| Percentage of Participants With Worst On-Study Hematological Abnormalities | ANC=Absolute Neutrophil Count. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. | On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
| Percentage of Participants With Worst On-Study Liver Abnormalities | ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. | On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
| Percentage of Participants With Worst On-Study Renal Abnormalities | CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. | On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
| Clinically Meaningful Changes in Vital Signs and Physical Examinations | Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure. | vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter |
| Tucson |
| Arizona |
| 85724 |
| United States |
| City of Hope National Medical Center | Duarte | California | 91010 | United States |
| San Diego Cancer Center | Encinitas | California | 92024 | United States |
| La Jolla Hematology and Oncology Medical Group | La Jolla | California | 92037 | United States |
| Scripps Cancer Center | La Jolla | California | 92037 | United States |
| Moores UCSD Cancer Center | La Jolla | California | 92093 | United States |
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
| Cancer Institute Medical Group, Inc | Los Angeles | California | 90025 | United States |
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| North County Oncology Medical Clinical, Inc. | Oceanside | California | 92056 | United States |
| City of Hope Medical Group | Pasadena | California | 91105 | United States |
| University of California, San Diego | San Diego | California | 92103 | United States |
| St. Mary's Medical Center - Northern California Melanoma Center | San Francisco | California | 94109 | United States |
| Cancer Institute Medical Group, Inc | Santa Monica | California | 90404 | United States |
| San Diego Cancer Center | Vista | California | 92081 | United States |
| Anschutz Cancer Pavilion | Aurora | Colorado | 80010 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80304 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80909 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| University of Colorado Hospital | Denver | Colorado | 80262 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers | Littleton | Colorado | 80120 | United States |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer Centers | Longmont | Colorado | 80501 | United States |
| Yale University School of Medicine - Oncology Outpatient Clinic | New Haven | Connecticut | 06520 | United States |
| Mount Sinai Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | United States |
| Memorial Regional Cancer Center | Hollywood | Florida | 33021 | United States |
| Shands Jacksonville | Jacksonville | Florida | 32209 | United States |
| University of Florida/Jacksonville Faculty Clinic | Jacksonville | Florida | 32209 | United States |
| Jackson Memorial Hospital & Clinics | Miami | Florida | 33136 | United States |
| University of Miami Hospital & Clinics | Miami | Florida | 33136 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| M.D. Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| Palm Beach Cancer Institute | Palm Beach Gardens | Florida | 33410 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Palm Beach Cancer Institute | Wellington | Florida | 33414 | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | United States |
| Emory University Hospital-Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Cancer Care Specialists of Central IL | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Cancer Care Specialists of Central IL | Effingham | Illinois | 62401 | United States |
| Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr. | Maywood | Illinois | 60153 | United States |
| Center for Cancer Care at Goshen Health System | Goshen | Indiana | 46526 | United States |
| Indiana Oncology Hematology Consultants North | Indianapolis | Indiana | 46202 | United States |
| American Health Network of IN, LLC | Indianapolis | Indiana | 46237 | United States |
| Indiana Oncology Hematology South | Indianapolis | Indiana | 46237 | United States |
| Indiana Oncology Hematology Consutants of Noblesville | Noblesville | Indiana | 46060 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Norton Hospital | Louisville | Kentucky | 40202 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Lutherville | Maryland | 21093 | United States |
| Beth Isreal Dec Medical Center | Boston | Massachusetts | 02115 | United States |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Henry Ford Medical Center | Dearborn | Michigan | 48126 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Henry Ford Medical Center- West Bloomfield | West Bloomfield | Michigan | 48322 | United States |
| Humphrey Cancer Center | Coon Rapids | Minnesota | 55433 | United States |
| Humphrey Cancer Center | Fridley | Minnesota | 55432 | United States |
| Hubert H Humphrey Cancer Center | Robbinsdale | Minnesota | 55422 | United States |
| Family Cancer Center | Olive Branch | Mississippi | 38654 | United States |
| Ellis Fischel Cancer Center | Columbia | Missouri | 65203 | United States |
| St. Joseph Oncology, Inc | Saint Joseph | Missouri | 64507 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington Unv. School of Med./ Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| The Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Hematology-Oncology Associates of Northern NJ, PA | Morristown | New Jersey | 07962 | United States |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| The Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Overlook Oncology Center | Summit | New Jersey | 07901 | United States |
| New Mexico Oncology Hematology Consultants, Ltd. | Albuquerque | New Mexico | 87109 | United States |
| Hematology-Oncology Associates of CNY | East Syracuse | New York | 13057 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Columbia University Medical Center, Irving Center for Clinical Research | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7050 | United States |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | 45219 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| The Oregon Clinical | Portland | Oregon | 97213 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Thomas Jefferson University Hosptital | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Hillman Cancer Research Pavilion | Pittsburgh | Pennsylvania | 15213 | United States |
| Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | United States |
| Cancer Centers of the Carolinas | Easley | South Carolina | 29640 | United States |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29615 | United States |
| Cancer Centers of the Carolinas | Seneca | South Carolina | 29672 | United States |
| Cancer Centers of the Carolinas | Spartanburg | South Carolina | 29307 | United States |
| Family Cancer Center | Bartlett | Tennessee | 38133 | United States |
| Family Cancer Center | Collierville | Tennessee | 38017 | United States |
| Family Cancer Center | Memphis | Tennessee | 38119 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Arlington Cancer Center | Arlington | Texas | 76012 | United States |
| Center for Oncology Research and Treatment | Dallas | Texas | 75230 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| Center for Oncology Research and Treatment | Richardson | Texas | 75080 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112-5550 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05405 | United States |
| Hospital Municipal de Oncoligia Maria Curie | Ciudad de Buenos Aires | Buenos Aires | Argentina |
| Instituto Medico Platense | La Plata | Buenos Aires | 1900 | Argentina |
| ISIS Clinica Especializada | Santa Fe | Santa Fe Province | Argentina |
| Hospital Militar Central | Buenos Aires | Argentina |
| Instituto Medico Especializado Alexander Fleming | Buenos Aires | Argentina |
| Hospital Britanico de Buenos Aires | Ciudad de Buenos Aires | C1280AEB | Argentina |
| Hospital Municipal de Oncologia Maria Curie | Ciudad de Buenos Aires | C1405BWU | Argentina |
| Hospital General de Agudos Carlos G. Durand | Ciudad de Buenos Aires | C1405DCS | Argentina |
| Instituto de Oncologia Angel H. Roffo | Ciudad de Buenos Aires | C1417DTB | Argentina |
| Hospital Militar Central | Ciudad de Buenos Aires | C1426BOS | Argentina |
| Instituto Alexander Fleming | Ciudad de Buenos Aires | C1426DRB | Argentina |
| Hospital Privado de Cordoba S.A. | Córdoba | X5016KEH | Argentina |
| Hospital Privado Centro Medico de Cordoba S.A. | Córdoba | Argentina |
| ISIS Clinica Especializada | Santa Fe | S3000FFU | Argentina |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Erasme Hospital, Free Universtiy of Brussels | Brussels | 1070 | Belgium |
| Erasme Hospital | Brussels | 1070 | Belgium |
| U.Z. Gent | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Gasthuisberg | Leuven | 3000 | Belgium |
| Cliniques Universitaires UCL de Mont-Godinne | Yvoir | 5530 | Belgium |
| Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias | Goiânia | Goiás | Brazil |
| Pro Onco Centro Tratamento Oncologico | Londrina | Paraná | Brazil |
| Hospital Sao Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | Brazil |
| Fundacao Pio XII - Hospital de Cancer de Barretos | Barretos | São Paulo | Brazil |
| Fundacoa Hospital Amaral Carvalho | Jaú | São Paulo | Brazil |
| Santo Andre Diagnosticos aTratamentos | Santo André | São Paulo | Brazil |
| Sociedade Beneficante de Sennores - Hospital Sino Libante | São Paulo | São Paulo | Brazil |
| Hospital de Cancer de Barretos - Fundacao Pio XII | Barretos - SP | 14784-400 | Brazil |
| Biocor - Hosp. de Doencas Cardiovasculares Ltda. | Belo Horizonte - MG | 34000-000 | Brazil |
| Hospital Araujo Jorge | Goiania - GO | 74605-070 | Brazil |
| Pro Onco Centro Tratemento Oncologico | Londrina - PR | 86050-190 | Brazil |
| Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD | Porto Alegre | 90035-003 | Brazil |
| Fund. SOAD / HC de Porto Alegre | Porto Alegre - RS | 90035-003 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre - RS | 90610-000 | Brazil |
| Santo Andre Diagnosticos e Tratamentos Ltda. | Santo Andre-SP | 09090-780 | Brazil |
| HC-FMUSP | Sao Paulo - SP | 05403-000 | Brazil |
| Hospital Sirio Labanes | Sao Paulo-SP | 01308-050 | Brazil |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Cancer Centre of Southeastern Ontario at KGH | Kingston | Ontario | K7L 5P9 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| The Ottawa Hospital Regional Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Sir Mortimer B. Davis - Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Instituto Nacional del Cancer | Independencia | Santiago Metropolitan | Chile |
| Clinica Davila | Recoleta | Santiago Metropolitan | Chile |
| Fundacion Arturo Lopez Perez | Santiago | Santiago Metropolitan | Chile |
| Hospital Barros Luco | Santiago | Santiago Metropolitan | Chile |
| Clinica Renaca | Reñaca | Vina Del Mar | Chile |
| Centre Oscar Lambret | Lille | 59020 Cedex | France |
| Centre Leon Berard | Lyon | 69373 Cedex 08 | France |
| Hopital Sainte-Marguerite | Marseille | 13009 | France |
| Hopital Saint-Eloi | Montpellier | 34295 Cedex 5 | France |
| Hotel Dieu | Nantes | 44093 Cedex 1 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hopital Saint-Louis | Paris | 75010 10 | France |
| Centre Eugene Marquis | Rennes | 35042 Cedex | France |
| Centre-Hospitalier Universitaire de Saint-Etienne | Saint-Etienne | 42055 Cedex 2 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 Cedex | France |
| Institut Gustave Roussy (IGR) | Villejuif | 94805 Cedex | France |
| Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie | Hufelandstr. 55 | Hesse | 45122 | Germany |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Charite Universitaets medizin Berlin | Berlin | 10117 | Germany |
| Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Universitaetsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Universitaetsklinikum Erlangen | Erlangen | 91052 | Germany |
| Universitaetsklinikum Essen | Essen | 45122 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69115 | Germany |
| Klinikum der Friedrich-Schiller-Universitaet Jena | Jena | 07740 | Germany |
| Klinikum Mannheim gGmbH | Mannheim | 68167 | Germany |
| University of Mannheim | Mannheim | Germany |
| Klinikum Rechts der Isar / TU Muenchen | München | 81675 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | 97080 | Germany |
| National Institute of Oncology | Budapest | H-1122 | Hungary |
| University of Debrecen, Medical and Health Sciences Center | Debrecen | H-4012 | Hungary |
| Semmelweis Hospital | Miskolc | H-3529 | Hungary |
| University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center | Szeged | H-6720 | Hungary |
| Antoni Van Leeuwenhoek Ziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Vrije Universiteit Medisch Centrum (VUMC) | Amsterdam | 1081 HV | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6229 HX | Netherlands |
| Mary Potter Oncology Centre | Groenkloof | 0181 | South Africa |
| GVI Oncology | Panorama | 7500 | South Africa |
| Mary Potter Oncology Centre | Pretoria | 0181 | South Africa |
| Sandton Onocology Medical Research | Sandton | 2199 | South Africa |
| Centre Hospitalier Universitaire Vaudois - CHUV | Lausanne | Rue Du Bugnon 46 | CH-1011 | Switzerland |
| Centre Hospitalier Universitaire Vaudois - CHUV | Lausanne | CH-1011 | Switzerland |
| Dermatologische Klinik Universitatsspital Zurich | Zurich | 8091 | Switzerland |
| St. Luke's Cancer Center, The Royal Surrey County Hospital | Guildford | Surry | GU2 7XX | United Kingdom |
| Velindre Hospital | Cardiff | CF14 2TL | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Poole Hospital | Poole | BH15 2JB | United Kingdom |
| Weston Park Hospital | Sheffield | S10 2SJ | United Kingdom |
| Southampton General | Southampton | SO16 6YD | United Kingdom |
| 25667295 | Derived | Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9. |
| 25649350 | Derived | Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3. |
| 25214238 | Derived | Hatswell AJ, Pennington B, Pericleous L, Rowen D, Lebmeier M, Lee D. Patient-reported utilities in advanced or metastatic melanoma, including analysis of utilities by time to death. Health Qual Life Outcomes. 2014 Sep 10;12:140. doi: 10.1186/s12955-014-0140-1. |
| 23942774 | Derived | McDermott D, Haanen J, Chen TT, Lorigan P, O'Day S; MDX010-20 investigators. Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20). Ann Oncol. 2013 Oct;24(10):2694-2698. doi: 10.1093/annonc/mdt291. Epub 2013 Aug 13. |
| 23444228 | Derived | Robert C, Schadendorf D, Messina M, Hodi FS, O'Day S; MDX010-20 investigators. Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res. 2013 Apr 15;19(8):2232-9. doi: 10.1158/1078-0432.CCR-12-3080. Epub 2013 Feb 26. |
| 23400564 | Derived | Weber JS, Dummer R, de Pril V, Lebbe C, Hodi FS; MDX010-20 Investigators. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013 May 1;119(9):1675-82. doi: 10.1002/cncr.27969. Epub 2013 Feb 7. |
| 22694829 | Derived | Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, Safikhani S, Messina M, Hoos A, Wagner S, Kotapati S. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66. |
| 20525992 | Derived | Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbe C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5. |
| FG001 | Ipilimumab Monotherapy | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| FG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipilimumab Plus gp100 | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| BG001 | Ipilimumab Monotherapy | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| BG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Duration of Melanoma | Duration of melanoma is the number of years from date of initial diagnosis to the date of randomization. The randomization of 1 participant in the ipilumumab monotherapy cohort was prior to the initial diagnostic date. Data for 2 participants in the ipilimumab + gp100 cohort were missing. | Mean | Full Range | years |
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| Melanoma Stage | The "M" in the TNM (tumor, node, metastasis) system refers to distant metastases-whether, and how far, the cancer has spread outside the original site. M0: There is no evidence that the cancer has spread beyond the original site. M1: The cancer has spread beyond the original site. M1a: The cancer has spread to other areas of skin, underneath the epidermis to the dermis (subcutaneous), or to lymph node(s). M1b: The cancer has spread to the lung(s) only. M1c: The cancer has spread to other organs and/or locations in the body with or without elevated LDH. | Number | Participants |
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| Prior Interleukin-2 Therapy | Number | Participants |
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| Lactate Dehydrogenase | Upper limit of normal (ULN) was 250 U/L for most assessments (some variation caused by tests performed at local laboratories). | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone | OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Median | 95% Confidence Interval | months | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) |
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| Secondary | Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy | OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Median | 95% Confidence Interval | months | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) |
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| Secondary | 12-, 18-, and 24-Month Survival Rates | The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Number | 95% Confidence Interval | probability | Month 12, Month 18, Month 24 |
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| Secondary | Progression Free Survival (PFS) | PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Subjects who neither progressed nor died were censored at the date of the last tumor assessment. | Posted | Median | 95% Confidence Interval | months | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) |
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| Secondary | Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24 | PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Median | 95% Confidence Interval | percentage of participants | Week 12, Week 24 |
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| Secondary | Time to Progression (TTP) | TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Median | 95% Confidence Interval | months | from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks]) |
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| Secondary | Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD) | Investigator's assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations >=4 weeks apart, no evidence of PD. PR: >=50% ↓ in sum of products of longest diameter & greatest perpendicular diameter of all target lesions compared to baseline by 2 observations >=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ >=25% in sum of products of longest diameter & greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of >= 1 new lesion. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Number | participants | BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1. |
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| Secondary | Determination of Best Overall Response Rate (BORR) | Response was based on the investigators' assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to week 24 |
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| Secondary | Time to Response | Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator. | Responder subjects in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Mean | Full Range | months | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) |
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| Secondary | Duration of Response | Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first). | Responders only in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Patients who did not progress or died were censored at the date of their last tumor assessment. | Posted | Median | 95% Confidence Interval | months | from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) |
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| Secondary | Disease Control Rate (DCR) | Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to week 24 |
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| Secondary | Delayed Response (Response Beyond Week 24) | Response was based on the investigators' assessment using modified World Health Organization (WHO) criteria. Delayed response is defined as post Week 24 overall response for the subjects who have PD before or at Week 24. Evaluation of delayed overall response is compared to baseline assessment. Delayed response includes delayed late CR, delayed late PR, delayed late SD, continued PD, unknown, and missing after Week 24. The delayed response of CR and PR also must have been confirmed. | Number of subjects with BOR of PR/SD (80 subjects ipi + gp100 , 37 ipi , 15 gp100) plus number of subjects with BOR of PD that had subsequent evaluation (8 ipi + gp100, 3 ipi, 3 gp100). | Posted | Number | participants | from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) |
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| Secondary | Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12 | The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe). | All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (Day 1, Cycle1), Week 12 |
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| Secondary | Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death | An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used. | All subjects who received at least 1 dose or any partial dose of study medication. | Posted | Number | percentage of participants | On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
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| Secondary | Percentage of Participants With Immune-Related Adverse Events (irAEs) | An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of "Other irAEs" includes blood, eye, immune, infections, renal, and respiratory systems. | All subjects who received at least 1 dose or any partial dose of study medication. | Posted | Number | percentage of participants | On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
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| Secondary | Percentage of Participants With Worst On-Study Hematological Abnormalities | ANC=Absolute Neutrophil Count. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. | All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation. | Posted | Number | percentage of participants | On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
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| Secondary | Percentage of Participants With Worst On-Study Liver Abnormalities | ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. | All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation. | Posted | Number | percentage of participants | On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
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| Secondary | Percentage of Participants With Worst On-Study Renal Abnormalities | CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE. | All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation. | Posted | Number | percentage of participants | On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). |
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| Secondary | Clinically Meaningful Changes in Vital Signs and Physical Examinations | Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure. | All subjects who received at least 1 dose or any partial dose of study medication. | Posted | Number | participants | vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ipilimumab Monotherapy | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. | 55 | 131 | 124 | 131 | ||
| EG001 | Ipilimumab Plus gp100 | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. | 155 | 380 | 362 | 380 | ||
| EG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. | 52 | 132 | 124 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ABDOMINAL WALL MASS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| ACUTE HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
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| ADVERSE EVENT | General disorders | MedDRA 12.1 | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| ANGIOPATHY | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| APHASIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| APPENDICITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| ARTERIAL THROMBOSIS LIMB | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 12.1 | Systematic Assessment |
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| ATAXIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| ATONIC URINARY BLADDER | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| BACTERAEMIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BLADDER PAIN | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BLOOD CORTICOTROPHIN DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BREAST MASS | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BRONCHIAL OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIOPULMONARY FAILURE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CATHETER RELATED INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| COMA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ENTEROCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| EPIDURITIS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| EYELID INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GASTROINTESTINAL STOMA COMPLICATION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GLOMERULONEPHRITIS | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GUILLAIN-BARRE SYNDROME | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEPATITIS A | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| HEPATITIS B | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| HERNIA OBSTRUCTIVE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOGONADISM | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOPHAGIA | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOPHYSITIS | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOPITUITARISM | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INJECTION SITE ULCER | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO ABNORMAL | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INTRACRANIAL TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| INTUSSUSCEPTION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| IRIDOCYCLITIS | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| JAUNDICE CHOLESTATIC | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LEUKOCYTOCLASTIC VASCULITIS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MALIGNANT ASCITES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MENINGEAL DISORDER | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| METASTASES TO BREAST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| METASTASES TO SPINE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| METASTATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| METASTATIC PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MYOCLONUS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PAINFUL RESPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PERIRECTAL ABSCESS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PERITONITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| POLYMYALGIA RHEUMATICA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| PROCTALGIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PSEUDOMONAL SEPSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RECTAL STENOSIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RENAL TUBULAR NECROSIS | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RESPIRATORY DEPRESSION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SUPERIOR VENA CAVAL OCCLUSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| TOXIC EPIDERMAL NECROLYSIS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| URINE OUTPUT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ADVERSE EVENT | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INJECTION SITE INDURATION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D000911 | Antibodies, Monoclonal |
| D058951 | gp100 Melanoma Antigen |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008565 | Membrane Proteins |
| D058950 | Melanoma-Specific Antigens |
| D009363 | Neoplasm Proteins |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Black |
|
| Hispanic |
|
| Other |
|
| M1a |
|
| M1b |
|
| M1c |
|
| Yes |
|
| <=ULN |
|
| unknown |
|
Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| Ipilimumab Monotherapy |
Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| OG001 | Ipilimumab Monotherapy | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| Ipilimumab Monotherapy |
Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| OG001 | Ipilimumab Monotherapy | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| OG001 | Ipilimumab Monotherapy | Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| Ipilimumab Monotherapy |
Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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| OG002 | gp100 | Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy. |
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