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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
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Secondary ID [1]
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2016-001941-26
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Secondary ID [2]
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CA209-742
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Experimental: Nivolumab and Ipilimumab Concomitant Administration - Followed by Nivolumab monotherapy
Experimental: Nivolumab and Ipilimumab Sequential Administration - Followed by Nivolumab monotherapy
Other interventions: Nivolumab
-Specified dose on specified days
Other interventions: Ipilimumab
-Specified dose on specified days
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)
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Assessment method [1]
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This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ. Such AEs include any acute systemic reaction characterized by a large list of terms, including (but not limited to) pruritus, urticaria, flushing, hypotension, respiratory distress, and vascular insufficiency. It also includes other signs and symptoms such as asthma, choking sensation, coughing, sneezing, and difficulty breathing due to laryngeal spasm and/or bronchospasm. Less frequent clinical presentations are also captured and include hyperventilation, sensation of foreign body, and ocular edema.
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Timepoint [1]
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Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
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Secondary outcome [1]
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Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ
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Assessment method [1]
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This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction narrow scope SMQ. The narrow scope SMQ is composed of a large list of terms, including (but not limited to) anaphylactic shock and reaction, shock and shock symptoms, and circulatory collapse, among the others.
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Timepoint [1]
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Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
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Secondary outcome [2]
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Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs
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Assessment method [2]
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This outcome describes the percentage of participants experiencing at least 1 AE in the Hypersensitivity/Infusion select AEs category. The select AEs consist of a list of preferred terms defined by the Sponsor and represent AEs with a potential immune-mediated etiology. The following 5 MedDRA preferred terms are included in the hypersensitivity/infusion reaction select AE category: Anaphylactic Reaction, Anaphylactic Shock, Bronchospasm, Hypersensitivity, and Infusion Related Reaction
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Timepoint [2]
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Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
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Secondary outcome [3]
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Percentage of Participants Affected by All Causality Grade 3 - 5 AEs
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Assessment method [3]
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This outcome describes the percentage of participants who experienced at least 1 AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria
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Timepoint [3]
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From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
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Secondary outcome [4]
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Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs
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Assessment method [4]
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This outcome describes the percentage of participants who experienced at least 1 Drug-related AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria
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Timepoint [4]
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From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
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Secondary outcome [5]
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Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI)
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Assessment method [5]
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Timepoint [5]
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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.
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Secondary outcome [6]
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Geometric Mean Concentration of Nivolumab at End of Infusion (EOI)
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Assessment method [6]
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Timepoint [6]
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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
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Secondary outcome [7]
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Geometric Mean Trough Concentration of Ipilimumab
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Assessment method [7]
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Timepoint [7]
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From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
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Secondary outcome [8]
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Geometric Mean Trough Concentration of Nivolumab
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Assessment method [8]
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Timepoint [8]
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From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
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Secondary outcome [9]
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Objective Response Rate (ORR)
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Assessment method [9]
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The ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first.
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Timepoint [9]
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Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months)
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Secondary outcome [10]
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Progression Free Survival (PFS)
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Assessment method [10]
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PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first.
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Timepoint [10]
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From the date of randomization to the first date of documented progression (approximately 26 months)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/10/2019
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Melanoma Institute Australia - North Sydney
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Recruitment hospital [2]
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Greenslopes Private Hospital - Greenslopes
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Recruitment hospital [3]
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Cabrini Hospital - Malvern
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Recruitment postcode(s) [1]
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- North Sydney
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Recruitment postcode(s) [2]
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- Greenslopes
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Recruitment postcode(s) [3]
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- Malvern
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Lyon Cedex 08
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Country [2]
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France
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State/province [2]
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Marseille Cedex 5
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Country [3]
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France
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State/province [3]
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Nantes Cedex 1
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Country [4]
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France
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State/province [4]
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Paris Cedex 14
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Country [5]
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France
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State/province [5]
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Paris
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Country [6]
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France
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State/province [6]
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Tours
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Country [7]
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Italy
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State/province [7]
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Genova
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Country [8]
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Italy
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State/province [8]
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Meldola (FC)
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Country [9]
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Italy
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State/province [9]
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Milan
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Country [10]
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Italy
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State/province [10]
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Torino
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Country [11]
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Spain
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State/province [11]
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Barcelona
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Country [12]
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Spain
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State/province [12]
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Madrid
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Country [13]
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Spain
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State/province [13]
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02905266
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02905266
Download to PDF