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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/NCT02599402
Registration number
NCT02599402
Ethics application status
Date submitted
5/11/2015
Date registered
6/11/2015
Date last updated
15/06/2021
Titles & IDs
Public title
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
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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
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Secondary ID [1]
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2015-001274-17
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Secondary ID [2]
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CA209-401
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 401
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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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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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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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Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
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Assessment method [1]
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Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
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Timepoint [1]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [1]
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Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
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Assessment method [1]
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Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity
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Timepoint [1]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [2]
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Median Time to Onset (Grades 3-4) of Select Adverse Events
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Assessment method [2]
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Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
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Timepoint [2]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [3]
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Median Time to Resolution (Grades 3-4) of Select Adverse Events
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Assessment method [3]
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Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
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Timepoint [3]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [4]
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Time to Resolution of an Adverse Event (AE)
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Assessment method [4]
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Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
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Timepoint [4]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive
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Timepoint [5]
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Up to approximately 37 months
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Secondary outcome [6]
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Incidence of Participants With Adverse Events
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Assessment method [6]
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The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths
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Timepoint [6]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [7]
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Incidence of Participants With Select Adverse Events
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Assessment method [7]
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The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
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Timepoint [7]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [8]
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Incidence of Participants With Laboratory Abnormalities - Liver
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Assessment method [8]
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Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)
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Timepoint [8]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [9]
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Incidence of Participants With Laboratory Abnormalities - Thyroid
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Assessment method [9]
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Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)
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Timepoint [9]
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From first dose to 30 days after last dose (up to approximately 37 months)
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Secondary outcome [10]
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Objective Response Rate (ORR)
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Assessment method [10]
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Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants
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Timepoint [10]
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Up to approximately 37 months
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Secondary outcome [11]
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Progression Free Survival (PFS)
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Assessment method [11]
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Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
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Timepoint [11]
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Up to approximately 37 months
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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.
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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
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
20/12/2015
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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
10/02/2020
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Sample size
Target
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Accrual to date
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Final
533
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Local Institution - Garran
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Local Institution - Nedlands
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2605 - Garran
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Recruitment postcode(s) [2]
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2050 - Camperdown
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2450 - Coffs Harbour
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Recruitment postcode(s) [4]
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2290 - Gateshead
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2060 - North Sydney
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0810 - Tiwi
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Recruitment postcode(s) [7]
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4102 - Brisbane
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Recruitment postcode(s) [8]
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4870 - Cairns
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Recruitment postcode(s) [9]
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4120 - Greenslopes
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Recruitment postcode(s) [10]
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4215 - Southport
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Recruitment postcode(s) [11]
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5000 - Adelaide
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Recruitment postcode(s) [12]
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5402 - Bedford Park
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Recruitment postcode(s) [13]
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7000 - Hobart
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Recruitment postcode(s) [14]
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3004 - Melbourne
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Recruitment postcode(s) [15]
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3128 - Melbourne
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Recruitment postcode(s) [16]
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3144 - Melbourne
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Recruitment postcode(s) [17]
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6150 - Murdoch
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Recruitment postcode(s) [18]
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6009 - Nedlands
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Recruitment outside Australia
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Austria
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Graz
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Austria
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Innsbruck
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Helsinki
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Oulu
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Finland
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Tampere
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Finland
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Turku
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Angers Cedex 9
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Bordeaux
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Sheffield
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Southampton
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Swansea
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Truro
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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
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02599402
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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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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02599402
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