Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as Fir... | Not Recruiting
Nivolumab Combined With Ipilimumab ... | Not Recruiting
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
CheckMate 401

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Medical Conditions
  • Melanoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02599402
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Nivolumab, Drug : Ipilimumab

Study Arm Groups : Combination therapy: Nivolumab + Ipilimumab, Monotherapy: Nivolumab, Combination therapy: Nivolumab + Ipilimumab

Intervention Type
See Interventions above
Primary Outcome Measures
    Rate and frequency for high-grade (CTCAE v4.0 Grade 3-5) treatment-related, select adverse events in study subjects; approximately 24 months
Secondary Outcome Measures
    Incidence of all high-grade (Grades 3-5), select adverse events; approximately 24 months; Median time to onset (Grades 3-4) of select adverse events; approximately 24 months; Median time to resolution (Grades 3-4) of select adverse events; approximately 24 months; Resolution of an Adverse Event (AE); approximately 24 months; Overall survival time from first dosing date to the date of death.; approximately 5 years; Safety will be measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs; approximately 5 years; Tolerability will be measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs; approximately 5 years; ORR; approximately 5 years; Investigator-assessed Progression free survival (PFS); approximately 5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
615
Participant Inclusion 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 The subjects who received previous primary treatment and any additional treatment (which is given after the primary treatment) are permitted if it was completed at least 6 weeks prior to study entry and if the side effects of the treatment are resolved If subjects received any of the following primary treatment previously; they are not permitted to be enrolled in the study (anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other drug specifically targeting T-cell costimulation or checkpoint pathways such as anti-CD-137)

    - 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:

    - There is no current (and not previously treated) disease spread to the brain

    - Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti PD-L1 or anti-PD-L2, anti-CD-137 agents (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) for adjuvant, neo-adjuvant, or advanced melanoma treatment or as part of clinical trial

    - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood
England
HA6 2RN
Rosemere Cancer Centre at Royal Preston Hospital
Fulwood
England
PR2 9HT
Southampton General Hospital
Southampton
England
SO16 6YD
South West Wales Cancer Institute
Sketty
Wales
SA2 8QA
GSK Investigational Site
Cambridge
CB2 0QQ
Guy's Hospital
London
SE1 9RT
Musculoskeletal Department; Freeman Hospital
Newcastle upon Tyne
NE7 7DN
Nottingham
Nottinghamshire
NG5 1PB
Truro
TR1 3LJ
GSK Investigational Site
Cottingham
HU16 5JQ
Sheffield
S10 2SJ
Glasgow
G12 0YN
Site Reference ID/Investigator# 125695
Birkenhead
CH63 4JY
Oxford University Hospital NHS Trust Churchill Hospital
Oxford
Oxfordshire
OX3 7LE
Local Institution
Sutton
Surrey
SM25PT
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Austria, Belgium, Finland, France, Germany, Ireland, Italy, Norway, Sweden, Switzerland, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CA209-401
Sponsor(s)
Bristol-Myers Squibb
Key Dates

Recruitment Start Date

Dec 2015

Recruitment End Date

Dec 2021

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

05 Nov 2015

Date updated in source

14 Sep 2017