Clinical trial NCT02599402: Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-11-06
Enrollment: 533
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
Secondary outcomes:
measure: Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
measure: Median Time to Onset (Grades 3-4) of Select Adverse Events
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
measure: Median Time to Resolution (Grades 3-4) of Select Adverse Events
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
measure: Time to Resolution of an Adverse Event (AE)
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
measure: Overall Survival (OS)
timeFrame: Up to approximately 37 months
measure: Incidence of Participants With Adverse Events
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
measure: Incidence of Participants With Select Adverse Events
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
measure: Incidence of Participants With Laboratory Abnormalities - Liver
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
measure: Incidence of Participants With Laboratory Abnormalities - Thyroid
timeFrame: From first dose to 30 days after last dose (up to approximately 37 months)
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 37 months
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 37 months
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Local Institution
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Local Institution
state: New South Wales
city: Gateshead
country: Australia
facility: Local Institution
state: New South Wales
city: North Sydney
country: Australia
facility: Local Institution
state: New South Wales
city: Tiwi
country: Australia
facility: Local Institution
state: Northern Territory
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Cairns
country: Australia
facility: Local Institution
state: Queensland
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Southport
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Bedford Park
country: Australia
facility: Local Institution
state: South Australia
city: Hobart
country: Australia
facility: Local Institution
state: Tasmania
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution
state: Western Australia
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Graz
country: Austria
facility: Local Institution
city: Innsbruck
country: Austria
facility: Local Institution
city: Salzburg
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Brussel
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Helsinki
country: Finland
facility: Local Institution
city: Oulu
country: Finland
facility: Local Institution
city: Tampere
country: Finland
facility: Local Institution
city: Turku
country: Finland
facility: Local Institution
city: Angers Cedex 9
country: France
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Boulogne Billancourt
country: France
facility: Local Institution
city: Clermont-Ferrand
country: France
facility: Local Institution
city: Dijon
country: France
facility: Local Institution
city: Grenoble Cedex 09
country: France
facility: Local Institution
city: Le Mans Cedex 9
country: France
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Marseille
country: France
facility: Local Institution
city: Montpellier
country: France
facility: Local Institution
city: Nantes Cedex 01
country: France
facility: Local Institution
city: Nice
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Pierre Benite Cedax
country: France
facility: Local Institution
city: Rennes Cedex
country: France
facility: Local Institution
city: Rouen Cedex
country: France
facility: Local Institution
city: TOULOUSE Cedex 9
country: France
facility: Local Institution
city: Vandoeuvre-les-Nancy
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
state: Rhineland-palladium
city: Berlin
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Erfurt
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Freiburg
country: Germany
facility: Local Institution
city: Gottingen
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Ludwigshafen
country: Germany
facility: Local Institution
city: Luebeck
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Regensburg
country: Germany
facility: Local Institution
city: Schwerin
country: Germany
facility: Local Institution
city: Stade
country: Germany
facility: Local Institution
city: Cork
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Galway
country: Ireland
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Meldola
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milan
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Terni
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Stavanger
country: Norway
facility: Local Institution
city: Eskilstuna
country: Sweden
facility: Local Institution
city: Gävle
country: Sweden
facility: Local Institution
city: Karlskrona
country: Sweden
facility: Local Institution
city: Linköping
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Sundsvall
country: Sweden
facility: Local Institution
city: Vasteras
country: Sweden
facility: Local Institution
city: Växjö
country: Sweden
facility: Local Institution
city: Basel
country: Switzerland
facility: Local Institution
city: Lausanne
country: Switzerland
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
city: Cambridge
country: United Kingdom
facility: Local Institution
city: Cottingham
country: United Kingdom
facility: Local Institution
city: Glasgow
country: United Kingdom
facility: Local Institution
city: Headington
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
city: Nottingham
country: United Kingdom
facility: Local Institution
city: Preston
country: United Kingdom
facility: Local Institution
city: Sheffield
country: United Kingdom
facility: Local Institution
city: Southampton
country: United Kingdom
facility: Local Institution
city: Swansea
country: United Kingdom
facility: Local Institution
city: Truro
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: