Back to resultsNivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma (CheckMate 401)
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Mount Vernon Hospital
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Combination therapy: Nivolumab + Ipilimumab
Monotherapy: Nivolumab
Arm Description
Nivolumab + Ipilimumab specified dose on specified days
Nivolumab specified dose on specified days
Outcomes
Primary Outcome Measures
Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
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
Secondary Outcome Measures
Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity
Median Time to Onset (Grades 3-4) of Select Adverse Events
Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time to Resolution of an Adverse Event (AE)
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
Overall Survival (OS)
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
Incidence of Participants With Adverse Events
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
Incidence of Participants With Select Adverse Events
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
Incidence of Participants With Laboratory Abnormalities - Liver
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)
Incidence of Participants With Laboratory Abnormalities - Thyroid
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)
Objective Response Rate (ORR)
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
Progression Free Survival (PFS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02599402
Brief Title
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
Acronym
CheckMate 401
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2015 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
533 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination therapy: Nivolumab + Ipilimumab
Arm Type
Experimental
Arm Description
Nivolumab + Ipilimumab specified dose on specified days
Arm Title
Monotherapy: Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Primary Outcome Measure Information:
Title
Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
Description
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
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Secondary Outcome Measure Information:
Title
Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
Description
Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Title
Median Time to Onset (Grades 3-4) of Select Adverse Events
Description
Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Title
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Description
Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Title
Time to Resolution of an Adverse Event (AE)
Description
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
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Title
Overall Survival (OS)
Description
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
Time Frame
Up to approximately 37 months
Title
Incidence of Participants With Adverse Events
Description
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
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Title
Incidence of Participants With Select Adverse Events
Description
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
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Title
Incidence of Participants With Laboratory Abnormalities - Liver
Description
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)
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Title
Incidence of Participants With Laboratory Abnormalities - Thyroid
Description
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)
Time Frame
From first dose to 30 days after last dose (up to approximately 37 months)
Title
Objective Response Rate (ORR)
Description
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
Time Frame
Up to approximately 37 months
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Up to approximately 37 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Local Institution
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Local Institution
City
Gateshead
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Facility Name
Local Institution
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Local Institution
City
Tiwi
State/Province
Northern Territory
ZIP/Postal Code
0810
Country
Australia
Facility Name
Local Institution
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Local Institution
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5402
Country
Australia
Facility Name
Local Institution
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Local Institution
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Local Institution
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Local Institution
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Local Institution
City
Turku
ZIP/Postal Code
FIN-20520
Country
Finland
Facility Name
Local Institution
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Boulogne Billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
Local Institution
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Local Institution
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Le Mans Cedex 9
ZIP/Postal Code
72037
Country
France
Facility Name
Local Institution
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Pierre Benite Cedax
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution
City
Rennes Cedex
ZIP/Postal Code
35042
Country
France
Facility Name
Local Institution
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Local Institution
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Mainz
State/Province
Rhineland-palladium
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Facility Name
Local Institution
City
Erfurt
ZIP/Postal Code
99028
Country
Germany
Facility Name
Local Institution
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Local Institution
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Local Institution
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Local Institution
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Facility Name
Local Institution
City
Stade
ZIP/Postal Code
21682
Country
Germany
Facility Name
Local Institution
City
Cork
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Local Institution
City
Galway
ZIP/Postal Code
ST4 6QG
Country
Ireland
Facility Name
Local Institution
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Local Institution
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution
City
Roma
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Local Institution
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Local Institution
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Local Institution
City
Gävle
ZIP/Postal Code
SE-80187
Country
Sweden
Facility Name
Local Institution
City
Karlskrona
ZIP/Postal Code
371 85
Country
Sweden
Facility Name
Local Institution
City
Linköping
ZIP/Postal Code
SE-58185
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Local Institution
City
Sundsvall
ZIP/Postal Code
164 40
Country
Sweden
Facility Name
Local Institution
City
Vasteras
ZIP/Postal Code
721 89
Country
Sweden
Facility Name
Local Institution
City
Växjö
ZIP/Postal Code
SE-35185
Country
Sweden
Facility Name
Local Institution
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution
City
Lausanne
ZIP/Postal Code
1005
Country
Switzerland
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Local Institution
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Local Institution
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution
City
Headington
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Local Institution
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Local Institution
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Local Institution
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Local Institution
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Local Institution
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
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BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
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