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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02599402




Registration number
NCT02599402
Ethics application status
Date submitted
5/11/2015
Date registered
6/11/2015
Date last updated
3/12/2018

Titles & IDs
Public title
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
Scientific title
Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401
Secondary ID [1] 0 0
2015-001274-17
Secondary ID [2] 0 0
CA209-401
Universal Trial Number (UTN)
Trial acronym
CheckMate 401
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: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab

Experimental: Combination therapy: Nivolumab + Ipilimumab - Nivolumab + Ipilimumab specified dose on specified days

Experimental: Monotherapy: Nivolumab - Nivolumab specified dose on specified days


Treatment: Drugs: Nivolumab


Treatment: Drugs: Ipilimumab


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate and frequency for high-grade (CTCAE v4.0 Grade 3-5) treatment-related, select adverse events in study subjects
Timepoint [1] 0 0
approximately 24 months
Secondary outcome [1] 0 0
Incidence of all high-grade (Grades 3-5), select adverse events
Timepoint [1] 0 0
approximately 24 months
Secondary outcome [2] 0 0
Median time to onset (Grades 3-4) of select adverse events
Timepoint [2] 0 0
approximately 24 months
Secondary outcome [3] 0 0
Median time to resolution (Grades 3-4) of select adverse events
Timepoint [3] 0 0
approximately 24 months
Secondary outcome [4] 0 0
Resolution of an Adverse Event (AE) - It is defined as a subject experiencing complete resolution or improvement to the baseline grade for the AE
Timepoint [4] 0 0
approximately 24 months
Secondary outcome [5] 0 0
Overall survival time from first dosing date to the date of death. - It is defined as a subject who has not died will be censored at last known date alive
Timepoint [5] 0 0
approximately 2 years
Secondary outcome [6] 0 0
Safety will be measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs - Select AEs such as pulmonary, gastrointestinal, skin, renal, hepatic, pancreatic, neurologic, endocrine, infusion-related, or hypersensitivity
Timepoint [6] 0 0
approximately 2 years
Secondary outcome [7] 0 0
Tolerability will be measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs
Timepoint [7] 0 0
approximately 2 years
Secondary outcome [8] 0 0
ORR - ORR is defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated subjects
Timepoint [8] 0 0
approximately 2 years
Secondary outcome [9] 0 0
Investigator-assessed Progression free survival (PFS) - Investigator-assessed PFS is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
Timepoint [9] 0 0
approximately 2 years

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- Potential subjects must have advanced Melanoma (stage III or IV as confirmed by
biopsy) with spread to other sites in the body and unable to be removed by surgery.

- Potential subjects must be newly diagnosed with advanced melanoma and received no
treatment for the advanced disease.

NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1,
anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell
costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was
used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs
must be discontinued 6 months prior to study entry and the side effects related to the
prior therapy resolved.

- Potential subjects (with disease spread to brain) who previously received primary
treatment are permitted if there was no evidence of disease as confirmed by the MRI
(at least 2 weeks after the primary treatment is complete and with in 6 weeks of the
first dose of the study drug). Potential subjects must not have received intravenous
steroid treatment (>10 mg/day) intravenously for at least 2 weeks prior to study drug
administration.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Leptomenigeal metastases

- Subjects with autoimmune disease. Subjects with Type I diabetes mellitus,
hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo,
psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected
to recur in the absence of an external trigger are permitted to enroll.

- All side effects from previous primary treatments other than alopecia, fatigue, or
peripheral neuropathy must have resolved to Grade 1 or baseline before administration
of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [3] 0 0
Local Institution - Gateshead
Recruitment hospital [4] 0 0
Local Institution - North Sydney
Recruitment hospital [5] 0 0
Local Institution - Tiwi
Recruitment hospital [6] 0 0
Local Institution - Brisbane
Recruitment hospital [7] 0 0
Local Institution - Cairns
Recruitment hospital [8] 0 0
Local Institution - Greenslopes
Recruitment hospital [9] 0 0
Local Institution - Southport
Recruitment hospital [10] 0 0
Local Institution - Adelaide
Recruitment hospital [11] 0 0
Local Institution - Bedford Park
Recruitment hospital [12] 0 0
Local Institution - Hobart
Recruitment hospital [13] 0 0
Local Institution - Box Hill
Recruitment hospital [14] 0 0
Local Institution - Melbourne
Recruitment hospital [15] 0 0
Local Institution - Murdoch
Recruitment hospital [16] 0 0
Local Institution - Perth
Recruitment hospital [17] 0 0
Local Institution - Camperdown
Recruitment hospital [18] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2290 - Gateshead
Recruitment postcode(s) [4] 0 0
2060 - North Sydney
Recruitment postcode(s) [5] 0 0
810 - Tiwi
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
4870 - Cairns
Recruitment postcode(s) [8] 0 0
4120 - Greenslopes
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
5042 - Bedford Park
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3004 - Melbourne
Recruitment postcode(s) [15] 0 0
3144 - Melbourne
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment postcode(s) [17] 0 0
6150 - Perth
Recruitment postcode(s) [18] 0 0
2050 - Camperdown
Recruitment postcode(s) [19] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussel
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Finland
State/province [7] 0 0
Helsinki
Country [8] 0 0
Finland
State/province [8] 0 0
Oulu
Country [9] 0 0
Finland
State/province [9] 0 0
Tampere
Country [10] 0 0
Finland
State/province [10] 0 0
Turku
Country [11] 0 0
France
State/province [11] 0 0
Angers
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Boulogne Billancourt
Country [14] 0 0
France
State/province [14] 0 0
Cedex
Country [15] 0 0
France
State/province [15] 0 0
Clermont-Ferrand
Country [16] 0 0
France
State/province [16] 0 0
Dijon
Country [17] 0 0
France
State/province [17] 0 0
Le Mans
Country [18] 0 0
France
State/province [18] 0 0
Lille
Country [19] 0 0
France
State/province [19] 0 0
Marseille
Country [20] 0 0
France
State/province [20] 0 0
Montpellier
Country [21] 0 0
France
State/province [21] 0 0
Nantes
Country [22] 0 0
France
State/province [22] 0 0
Nice
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Pierre Benite Cedex
Country [25] 0 0
France
State/province [25] 0 0
Rennes
Country [26] 0 0
France
State/province [26] 0 0
Rouen
Country [27] 0 0
France
State/province [27] 0 0
TOULOUSE Cedex 9
Country [28] 0 0
France
State/province [28] 0 0
Vandoeuvre les Nancy
Country [29] 0 0
France
State/province [29] 0 0
Villejuif
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Dresden
Country [32] 0 0
Germany
State/province [32] 0 0
Erfurt
Country [33] 0 0
Germany
State/province [33] 0 0
Erlangen
Country [34] 0 0
Germany
State/province [34] 0 0
Frankfurt
Country [35] 0 0
Germany
State/province [35] 0 0
Freiburg im Breisgau
Country [36] 0 0
Germany
State/province [36] 0 0
Gottingen
Country [37] 0 0
Germany
State/province [37] 0 0
Hannover
Country [38] 0 0
Germany
State/province [38] 0 0
Leipzig
Country [39] 0 0
Germany
State/province [39] 0 0
Ludwigshafen
Country [40] 0 0
Germany
State/province [40] 0 0
Luebeck
Country [41] 0 0
Germany
State/province [41] 0 0
Mainz
Country [42] 0 0
Germany
State/province [42] 0 0
Mannheim
Country [43] 0 0
Germany
State/province [43] 0 0
Regensburg
Country [44] 0 0
Germany
State/province [44] 0 0
Schwerin
Country [45] 0 0
Germany
State/province [45] 0 0
Stade
Country [46] 0 0
Ireland
State/province [46] 0 0
Cork
Country [47] 0 0
Ireland
State/province [47] 0 0
Dublin
Country [48] 0 0
Ireland
State/province [48] 0 0
Galway
Country [49] 0 0
Italy
State/province [49] 0 0
Bari
Country [50] 0 0
Italy
State/province [50] 0 0
Bergamo
Country [51] 0 0
Italy
State/province [51] 0 0
Genova
Country [52] 0 0
Italy
State/province [52] 0 0
Meldola
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Milan
Country [55] 0 0
Italy
State/province [55] 0 0
Napoli
Country [56] 0 0
Italy
State/province [56] 0 0
Padova
Country [57] 0 0
Italy
State/province [57] 0 0
Pisa
Country [58] 0 0
Italy
State/province [58] 0 0
Roma
Country [59] 0 0
Italy
State/province [59] 0 0
Siena
Country [60] 0 0
Italy
State/province [60] 0 0
Terni
Country [61] 0 0
Italy
State/province [61] 0 0
Torino
Country [62] 0 0
Norway
State/province [62] 0 0
Oslo
Country [63] 0 0
Norway
State/province [63] 0 0
Stavanger
Country [64] 0 0
Sweden
State/province [64] 0 0
Eskilstuna
Country [65] 0 0
Sweden
State/province [65] 0 0
Gavle
Country [66] 0 0
Sweden
State/province [66] 0 0
Karlskrona
Country [67] 0 0
Sweden
State/province [67] 0 0
Karlstad
Country [68] 0 0
Sweden
State/province [68] 0 0
Linkoping
Country [69] 0 0
Sweden
State/province [69] 0 0
Solna
Country [70] 0 0
Sweden
State/province [70] 0 0
Sundsvall
Country [71] 0 0
Sweden
State/province [71] 0 0
Vaxjo
Country [72] 0 0
Switzerland
State/province [72] 0 0
Basel
Country [73] 0 0
Switzerland
State/province [73] 0 0
Lausanne
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Cambridgeshire
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Yorkshire
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Cottingham
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Glasgow
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Headington
Country [79] 0 0
United Kingdom
State/province [79] 0 0
London
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Newcastle Upon Tyne
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Northwood
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Nottingham
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Preston
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Southampton
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Sutton.
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Swansea
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Truro

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the effects of combination treatment of Nivolumab
with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated
advanced Melanoma.
Trial website
https://clinicaltrials.gov/show/NCT02599402
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
Other publications