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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02714218




Registration number
NCT02714218
Ethics application status
Date submitted
16/03/2016
Date registered
21/03/2016
Date last updated
24/06/2022

Titles & IDs
Public title
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Scientific title
Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
CA209-511
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab 3 mg/kg IV
Treatment: Other - Ipilimumab 1 mg/kg IV
Treatment: Other - Nivolumab 6 mg/kg IV

Experimental: Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV - Specified dose on specified days

Experimental: Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV - Specified dose on specified days

Experimental: Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg - Specified dose on specified days


Treatment: Other: Nivolumab 3 mg/kg IV
Followed by Nivolumab monotherapy

Treatment: Other: Ipilimumab 1 mg/kg IV
Followed by Nivolumab monotherapy

Treatment: Other: Nivolumab 6 mg/kg IV
A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)
Timepoint [1] 0 0
From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years)
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years)
Secondary outcome [4] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Timepoint [4] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [5] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Timepoint [5] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [6] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Timepoint [6] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [7] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Timepoint [7] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [8] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Timepoint [8] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [9] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Timepoint [9] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [10] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Timepoint [10] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [11] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Timepoint [11] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [12] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Timepoint [12] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [13] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Timepoint [13] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [14] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Timepoint [14] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [15] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Timepoint [15] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [16] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Timepoint [16] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [17] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Timepoint [17] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40
Secondary outcome [18] 0 0
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Timepoint [18] 0 0
Weeks 7, 16, 20, 24, 28, 32, 36, 40

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com



* Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with active brain metastases or leptomeningeal metastases
* Subjects with ocular melanoma
* Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/05/2021
Sample size
Target
Accrual to date
Final
387
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - North Sydney
Recruitment hospital [2] 0 0
Local Institution - 0045 - Waratah
Recruitment hospital [3] 0 0
Local Institution - Greenslopes
Recruitment hospital [4] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Denmark
State/province [15] 0 0
Aarhus N
Country [16] 0 0
Denmark
State/province [16] 0 0
Herlev
Country [17] 0 0
Denmark
State/province [17] 0 0
Odense
Country [18] 0 0
France
State/province [18] 0 0
Bordeaux
Country [19] 0 0
France
State/province [19] 0 0
Lille
Country [20] 0 0
France
State/province [20] 0 0
Marseille Cedex 5
Country [21] 0 0
France
State/province [21] 0 0
Nantes Cedex
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Pierre Benite
Country [24] 0 0
France
State/province [24] 0 0
Toulouse Cedex 9
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Heidelberg
Country [28] 0 0
Germany
State/province [28] 0 0
Muenchen
Country [29] 0 0
Germany
State/province [29] 0 0
Tuebingen
Country [30] 0 0
Israel
State/province [30] 0 0
Ramat Gan
Country [31] 0 0
Italy
State/province [31] 0 0
Bergamo
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Napoli
Country [34] 0 0
Italy
State/province [34] 0 0
Padova
Country [35] 0 0
Italy
State/province [35] 0 0
Siena
Country [36] 0 0
Italy
State/province [36] 0 0
Taormina
Country [37] 0 0
Netherlands
State/province [37] 0 0
Amsterdam
Country [38] 0 0
Netherlands
State/province [38] 0 0
Groningen
Country [39] 0 0
Poland
State/province [39] 0 0
Gdansk
Country [40] 0 0
Poland
State/province [40] 0 0
Krakow
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Moscow
Country [43] 0 0
Spain
State/province [43] 0 0
Badalona-barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
San Sabastian Gipuzkoa
Country [47] 0 0
Spain
State/province [47] 0 0
Valencia
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Greater Manchester
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Oxfordshire
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Guildford
Country [51] 0 0
United Kingdom
State/province [51] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02714218