Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

Melanoma Clinical Trial

— CheckMate 066  

Official title:

A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721772
• Other study ID #: CA209-066
• Secondary ID: 2012-003718-16
• Status: Completed
• Phase: Phase 3
• Start date: January 18, 2013
• Est. completion date: May 14, 2021

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• BMS-936558 (Nivolumab)

• Placebo matching BMS-936558 (Nivolumab)

Drug:
• Dacarbazine

• Placebo matching Dacarbazine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Argentina,  Australia,  Canada,  Chile,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Mexico,  Norway,  Poland,  Spain,  Sweden, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting