Melanoma Clinical Trial
— CheckMate 066Official title:
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Verified date | June 2022 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma
Status | Completed |
Enrollment | 418 |
Est. completion date | May 14, 2021 |
Est. primary completion date | June 24, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Men and women =18 years of age - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer - Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1 - Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses - Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize Exclusion Criteria: - Active brain metastases or leptomeningeal metastases - Ocular melanoma - Any active, known, or suspected autoimmune disease |
Country | Name | City | State |
---|---|---|---|
Argentina | Fundacion Cidea | Buenos Aires | Distrito Federal |
Argentina | Instituto Medico Especialazado Alexander Fleming | Buenos Aires | |
Argentina | Instituto Oncologico De Cordoba | Cordoba | |
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Local Institution | Camperdown | New South Wales |
Australia | Coffs Harbour Health Campus | Coffs Harbour | New South Wales |
Australia | Greenslopes Private Hospital | Greenslopes | Queensland |
Australia | Cabrini Hospital | Malvern | Victoria |
Australia | Local Institution - 0006 | North Sydney | New South Wales |
Australia | Local Institution | Southport | Queensland |
Australia | Local Institution | Westmead | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Qe Ii Health Science Centre | Halfax | Nova Scotia |
Canada | Local Institution - 0040 | Montreal | Quebec |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Local Institution - 0039 | Vancouver | British Columbia |
Chile | Local Institution | Santiago | |
Chile | Local Institution | Santiago | Metropolitana |
Chile | Local Institution | Viña Del Mar | Valparaiso |
Denmark | Aarhus Universitetshospital | Aarhus | |
Denmark | Herlev Hospital | Herlev | |
Denmark | Odense University Hospital | Odense | |
Finland | Local Institution - 0035 | Helsinki | |
France | Hopital Saint Andre | Bordeaux | |
France | Chu Grenoble - Hopital Albert Michallon | Grenoble | |
France | Chru De Lille - Hopital Claude Huriez | Lille | |
France | Hopital St Eloi | Montpellier | |
France | Hopital Saint Louis | Paris | |
France | Local Institution - 0013 | Villejuif | |
Germany | Local Institution | Essen | |
Germany | Local Institution | Gera | |
Germany | Local Institution | Goettingen | |
Germany | Local Institution | Heidelberg | |
Germany | Local Institution | Kiel | |
Germany | Local Institution | Koeln | |
Germany | Local Institution | Magdeburg | |
Germany | Local Institution | Mainz | |
Germany | Local Institution | Nuernberg | |
Germany | Local Institution | Recklinghausen | |
Germany | Local Institution | Tubingen | |
Germany | Local Institution | Wuerzburg | Bayern |
Greece | Laiko Hospital | Athens | |
Greece | Metropolitan Hospital | Neo Faliro | |
Israel | Local Institution | Haifa | |
Israel | Local Institution | Jerusalem | |
Israel | Local Institution | Tel Hashomer | |
Italy | Local Institution | Bari | |
Italy | Local Institution | Bergamo | |
Italy | Local Institution | Genova | |
Italy | Local Institution | Meldola (fc) | |
Italy | Local Institution | Milano | |
Italy | Local Institution | Milano | |
Italy | Local Institution | Napoli | |
Italy | Local Institution | Padova | |
Italy | Local Institution | Roma | |
Italy | Local Institution | Siena | |
Mexico | Local Institution | Leon, Guanajato | Guanajuato |
Mexico | Local Institution | Mexico | Distrito Federal |
Mexico | Local Institution | Morelia | Michoacan |
Mexico | Local Institution | Tlalpan | Distrito Federal |
Norway | Local Institution | Oslo | |
Poland | Local Institution | Gdansk | |
Poland | Local Institution | Lodz | |
Poland | Local Institution | Warszawa | |
Spain | Local Institution - 0056 | Barcelona | |
Spain | Local Institution | Madrid | |
Spain | Local Institution | Madrid | |
Spain | Local Institution | San Sebastian | Guipuzcoa |
Spain | Local Institution | Sevilla | |
Spain | Local Institution | Valencia | |
Sweden | Local Institution | Gothenberg | |
Sweden | Local Institution | Lund | |
Sweden | Local Institution | Umea |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Argentina, Australia, Canada, Chile, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Norway, Poland, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. | From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months. | |
Primary | Overall Survival (OS) Rate | OS rate is calculated as the percentage of participants alive at the indicated timepoints | From randomization to 6 months and or to 12 months | |
Secondary | Progression-free Survival (PFS) | Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy. | From date of randomization up to date of disease progression or death, up to approximately 84 months | |
Secondary | Progression-free Survival (PFS) Rate | The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology. | From randomization to the specified timepoints, up to 84 months | |
Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of =5 mm. | Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months | |
Secondary | Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level | Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression =5% (PD-L1 positive) versus patients with tumor PD-L1 expression <5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization. | From date of randomization to date of disease progression or death, up to approximately 94 months | |
Secondary | Change From Baseline in Health-related Quality of Life (HRQoL) Scores | HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL. | At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months |
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