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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02905266




Registration number
NCT02905266
Ethics application status
Date submitted
14/09/2016
Date registered
19/09/2016
Date last updated
17/12/2020

Titles & IDs
Public title
A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
Scientific title
Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
2016-001941-26
Secondary ID [2] 0 0
CA209-742
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
Treatment: Other - Ipilimumab

Experimental: Nivolumab and Ipilimumab Concomitant Administration - Followed by Nivolumab monotherapy

Experimental: Nivolumab and Ipilimumab Sequential Administration - Followed by Nivolumab monotherapy


Treatment: Other: Nivolumab
-Specified dose on specified days

Treatment: Other: Ipilimumab
-Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)
Timepoint [1] 0 0
Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Secondary outcome [1] 0 0
Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ
Timepoint [1] 0 0
Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Secondary outcome [2] 0 0
Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs
Timepoint [2] 0 0
Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Secondary outcome [3] 0 0
Percentage of Participants Affected by All Causality Grade 3 - 5 AEs
Timepoint [3] 0 0
From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
Secondary outcome [4] 0 0
Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs
Timepoint [4] 0 0
From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
Secondary outcome [5] 0 0
Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI)
Timepoint [5] 0 0
From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported.
Secondary outcome [6] 0 0
Geometric Mean Concentration of Nivolumab at End of Infusion (EOI)
Timepoint [6] 0 0
From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported
Secondary outcome [7] 0 0
Geometric Mean Trough Concentration of Ipilimumab
Timepoint [7] 0 0
From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
Secondary outcome [8] 0 0
Geometric Mean Trough Concentration of Nivolumab
Timepoint [8] 0 0
From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
Secondary outcome [9] 0 0
Objective Response Rate (ORR)
Timepoint [9] 0 0
Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months)
Secondary outcome [10] 0 0
Progression Free Survival (PFS)
Timepoint [10] 0 0
From the date of randomization to the first date of documented progression (approximately 26 months)

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



* Males and Females, ages 15 years = of age (Except where local regulations and/or institutional policies do not allow for subjects < 18 years of age to participate)
* Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subjects have 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
Open (masking not used)
Who is / are masked / blinded?



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
27/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2019
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [2] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
- North Sydney
Recruitment postcode(s) [2] 0 0
- Greenslopes
Recruitment postcode(s) [3] 0 0
- Malvern
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Lyon Cedex 08
Country [2] 0 0
France
State/province [2] 0 0
Marseille Cedex 5
Country [3] 0 0
France
State/province [3] 0 0
Nantes Cedex 1
Country [4] 0 0
France
State/province [4] 0 0
Paris Cedex 14
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
France
State/province [6] 0 0
Tours
Country [7] 0 0
Italy
State/province [7] 0 0
Genova
Country [8] 0 0
Italy
State/province [8] 0 0
Meldola (FC)
Country [9] 0 0
Italy
State/province [9] 0 0
Milan
Country [10] 0 0
Italy
State/province [10] 0 0
Torino
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid
Country [13] 0 0
Spain
State/province [13] 0 0
Sevilla

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
Trial website
https://clinicaltrials.gov/study/NCT02905266
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02905266