MelanomaPhase 3CheckMate 401NCT02599402

Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma

A Phase 3 study testing Nivolumab and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 111 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: Nivolumab and Ipilimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 533 participants
Where: 111 sitesin 12 countries
Study dates: 20 Dec 2015to 10 Feb 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

111 sites in 12 countries.

Country

City, postcode or hospital

111 sites in 12 countries

France19 sites

Local Institution
Angers, 49933
Local Institution
Bordeaux, 33075
Local Institution
Boulogne-Billancourt, 92104
Local Institution
Clermont-Ferrand, 63003
Local Institution
Dijon, 21079
Local Institution
Grenoble, 38043
Local Institution
Le Mans, 72037
Local Institution
Lille, 59037
Local Institution
Marseille, 13385
Local Institution
Montpellier, 34295
Local Institution
Nantes, 44093
Local Institution
Nice, 06202
Local Institution
Paris, 75010
Local Institution
Pierre Benite Cedax, 69495
Local Institution
Rennes, 35042
Local Institution
Rouen, 76031
Local Institution
Toulouse, 31059
Local Institution
Vandœuvre-lès-Nancy, 54511
Local Institution
Villejuif, 94805

Other trials in France

Australia18 sites

Local Institution
Adelaide, South Australia, 5000
Local Institution
Bedford Park, South Australia, 5402
Local Institution
Brisbane, Queensland, 4102
Local Institution
Cairns, Queensland, 4870
Local Institution
Camperdown, New South Wales, 2050
Local Institution
Coffs Harbour, New South Wales, 2450
Local Institution
Garran, Australian Capital Territory, 2605
Local Institution
Gateshead, New South Wales, 2290
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Hobart, Tasmania, 7000
Local Institution
Melbourne, Victoria, 3004
Local Institution
Melbourne, Victoria, 3128
Local Institution
Melbourne, Victoria, 3144
Local Institution
Murdoch, Western Australia, 6150
Local Institution
Nedlands, Western Australia, 6009
Local Institution
North Sydney, New South Wales, 2060
Local Institution
Southport, Queensland, 4215
Local Institution
Tiwi, Northern Territory, 0810

Other trials in Australia

Germany17 sites

Local Institution
Berlin, 10117
Local Institution
Dresden, 01277
Local Institution
Erfurt, 99028
Local Institution
Erlangen, 91054
Local Institution
Frankfurt, 60590
Local Institution
Freiburg im Breisgau, 79104
Local Institution
Göttingen, 37075
Local Institution
Hanover, 30625
Local Institution
Kiel, 24105
Local Institution
Leipzig, 04103
Local Institution
Lübeck, 23538
Local Institution
Ludwigshafen, 67063
Local Institution
Mainz, Rhineland-palladium, 55131
Local Institution
Mannheim, 68167
Local Institution
Regensburg, 93053
Local Institution
Schwerin, 19049
Local Institution
Stade, 21682

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United Kingdom15 sites

Local Institution
Cambridge, CB2 0QQ
Local Institution
Cottingham, HU16 5JQ
Local Institution
Glasgow, G12 0YN
Local Institution
Headington, OX3 7LE
Local Institution
London, Greater London, SW3 6JJ
Local Institution
London, SE1 9RT
Local Institution
Manchester, M20 4BX
Local Institution
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Mount Vernon Hospital
Northwood, HA6 2RN
Local Institution
Nottingham, NG5 1PB
Local Institution
Preston, PR2 9HT
Local Institution
Sheffield, S10 2SJ
Local Institution
Southampton, SO16 6YD
Local Institution
Swansea, SA2 8QA
Local Institution
Truro, TR1 3LJ

Other trials in United Kingdom

Italy14 sites

Local Institution
Bari, 70124
Local Institution
Bergamo, 24127
Local Institution
Genova, 16132
Local Institution
Meldola, 47014
Local Institution
Milan, 20141
Local Institution
Milan, 20133
Local Institution
Naples, 80131
Local Institution
Padova, 35128
Local Institution
Pisa, 56126
Local Institution
Roma, 00144
Local Institution
Roma
Local Institution
Siena, 53100
Local Institution
Terni, 05100
Local Institution
Torino, 10126

Other trials in Italy

Sweden8 sites

Local Institution
Eskilstuna, 631 88
Local Institution
Gävle, SE-80187
Local Institution
Karlskrona, 371 85
Local Institution
Linköping, SE-58185
Local Institution
Stockholm, 17176
Local Institution
Sundsvall, 164 40
Local Institution
Västerås, 721 89
Local Institution
Vaxjo, SE-35185

Other trials in Sweden

Ireland6 sites

Local Institution
Cork
Local Institution
Dublin, 4
Local Institution
Dublin, 7
Local Institution
Dublin, 8
Local Institution
Dublin, 9
Local Institution
Galway, ST4 6QG

Other trials in Ireland

Austria4 sites

Local Institution
Graz, 8036
Local Institution
Innsbruck, 6020
Local Institution
Salzburg, 5020
Local Institution
Vienna, 1090

Other trials in Austria

Finland4 sites

Local Institution
Helsinki, 00290
Local Institution
Oulu, 90029
Local Institution
Tampere, 33520
Local Institution
Turku, FIN-20520

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Belgium2 sites

Local Institution
Brussels, 1090
Local Institution
Brussels, 1200

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Norway2 sites

Local Institution
Oslo, 0424
Local Institution
Stavanger, 4011

Other trials in Norway

Switzerland2 sites

Local Institution
Basel, 4031
Local Institution
Lausanne, 1005

Other trials in Switzerland

About this study

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

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.

Conditions: Melanoma
Being tested: Nivolumab, Ipilimumab
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabDrug
IpilimumabDrug

Study groups in NCT02599402
Study group	Role	What they receive
Combination therapy: Nivolumab + Ipilimumab	Experimental	Nivolumab + Ipilimumab specified dose on specified days Receives: Drug: Nivolumab; Drug: Ipilimumab
Monotherapy: Nivolumab	Experimental	Nivolumab specified dose on specified days Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From first dose to 30 days after last dose (up to approximately 37 months)

Secondary outcomes (11)

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
Measured: From first dose to 30 days after last dose (up to approximately 37 months)
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
Measured: From first dose to 30 days after last dose (up to approximately 37 months)
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
Measured: From first dose to 30 days after last dose (up to approximately 37 months)
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
Measured: From first dose to 30 days after last dose (up to approximately 37 months)
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
Measured: Up to approximately 37 months
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
Measured: From first dose to 30 days after last dose (up to approximately 37 months)
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
Measured: From first dose to 30 days after last dose (up to approximately 37 months)
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)
Measured: From first dose to 30 days after last dose (up to approximately 37 months)
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)
Measured: From first dose to 30 days after last dose (up to approximately 37 months)
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
Measured: Up to approximately 37 months
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.
Measured: Up to approximately 37 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 201510 Feb 2020

First posted6 Nov 2015 (estimated)
Study start20 Dec 2015
Primary completion10 Feb 2020
Study completion10 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MelanomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 533 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02599402
Sponsor's protocol ID: CA209-401
Other IDs: 2015-001274-17, 2015
Acronym: CheckMate 401
Status last verified: May 2021
First submitted: 5 Nov 2015
Last updated: 15 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Dummer R, Corrie P, Gutzmer R, Meniawy TM, Del Vecchio M, Lebbe C, Guida M, Dutriaux C, Dreno B, Meyer N, Ferrucci PF, Dalle S, Khattak MA, Grob JJ, Briscoe K, Larkin J, Mansard S, Lesimple T, Guidoboni M, Sabatini S, Richtig E, Herbst R, Lobo M, Askelson M, Ascierto PA, Maio M. First-Line, Fixed-Duration Nivolumab Plus Ipilimumab Followed by Nivolumab in Clinically Diverse Patient Populations With Unresectable Stage III or IV Melanoma: CheckMate 401. J Clin Oncol. 2023 Aug 10;41(23):3917-3929. doi: 10.1200/JCO.22.02199. Epub 2023 Jun 12.
PubMed 37307514

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02599402
Acronym / sponsor ID: CheckMate 401 / CA209-401
Conditions: Melanoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 533 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 20 Dec 2015 (actual)
Primary completion: 10 Feb 2020 (actual)
Study completion: 10 Feb 2020 (actual)
First posted: 6 Nov 2015 (estimated)
Results: Posted 15 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Combination therapy: Nivolumab + Ipilimumab	Experimental	Drug: Nivolumab, Drug: IpilimumabNivolumab + Ipilimumab specified dose on specified days
Monotherapy: Nivolumab	Experimental	Drug: NivolumabNivolumab specified dose on specified days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nivolumab	Drug	Combination therapy: Nivolumab + Ipilimumab, Monotherapy: Nivolumab
Ipilimumab	Drug	Combination therapy: Nivolumab + Ipilimumab

Primary outcome

Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
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

11 secondary outcomes

Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Median Time to Onset (Grades 3-4) of Select Adverse Events
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Time to Resolution of an Adverse Event (AE)
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Overall Survival (OS)
Time frame: Up to approximately 37 months
Incidence of Participants With Adverse Events
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Select Adverse Events
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Laboratory Abnormalities - Liver
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Laboratory Abnormalities - Thyroid
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Objective Response Rate (ORR)
Time frame: Up to approximately 37 months
Progression Free Survival (PFS)
Time frame: Up to approximately 37 months

Results and safety

Results posted to the registry on 15 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nivolumab + Ipilimumab Total	533	0

Primary outcome: Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events

Time frame: From first dose to 30 days after last dose (up to approximately 37 months). Count of participants. Unit: Participants

Measure	Nivolumab + Ipilimumab Total n = 533	Nivolumab + Ipilimumab ECOG PS0-1 n = 477	Nivolumab + Ipilimumab ECOG PS2 n = 55	Nivolumab + Ipilimumab Brain Metastasis n = 42	Nivolumab + Ipilimumab Mucosal n = 32	Nivolumab + Ipilimumab Ocular/Uveal n = 64	Nivolumab + Ipilimumab Cutaneous n = 365	Nivolumab + Ipilimumab Acral n = 10	Nivolumab + Ipilimumab Other n = 62
Pulmonary: Grade 3-4	7	7	0	0	0	1	6	0	0
Pulmonary: Grade 5	0	0	0	0	0	0	0	0	0
Gastrointestinal: Grade 3-4	83	79	4	5	5	9	57	1	11
Gastrointestinal: Grade 5	1	1	0	0	1	0	0	0	0
Skin: Grade 3-4	35	31	4	1	3	7	20	1	4
Skin: Grade 5	0	0	0	0	0	0	0	0	0
Renal: Grade 3-4	10	9	1	1	0	1	8	0	1
Renal: Grade 5	1	1	0	0	0	0	1	0	0

Population analysed: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose to 30 days after last dose (up to approximately 37 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nivolumab + Ipilimumab Total	356 of 533 (66.8%)	503 of 533 (94.4%)	199 of 533
Nivolumab + Ipilimumab ECOG PS0-1	324 of 477 (67.9%)	453 of 477 (95%)	169 of 477
Nivolumab + Ipilimumab ECOG PS2	31 of 55 (56.4%)	49 of 55 (89.1%)	29 of 55
Nivolumab + Ipilimumab Brain Metastasis	31 of 42 (73.8%)	37 of 42 (88.1%)	13 of 42
Nivolumab + Ipilimumab Mucosal	26 of 32 (81.3%)	28 of 32 (87.5%)	20 of 32
Nivolumab + Ipilimumab Ocular/Uveal	40 of 64 (62.5%)	61 of 64 (95.3%)	41 of 64
Nivolumab + Ipilimumab Cutaneous	238 of 365 (65.2%)	347 of 365 (95.1%)	107 of 365
Nivolumab + Ipilimumab Acral	9 of 10 (90%)	10 of 10 (100%)	6 of 10
Nivolumab + Ipilimumab Other	43 of 62 (69.4%)	57 of 62 (91.9%)	25 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37307514Dummer R, Corrie P, Gutzmer R, Meniawy TM, Del Vecchio M, Lebbe C, Guida M, Dutriaux C, Dreno B, Meyer N, Ferrucci PF, Dalle S, Khattak MA, Grob JJ, Briscoe K, Larkin J, Mansard S, Lesimple T, Guidoboni M, Sabatini S, Richtig E, Herbst R, Lobo M, Askelson M, Ascierto PA, Maio M. First-Line, Fixed-Duration Nivolumab Plus Ipilimumab Followed by Nivolumab in Clinically Diverse Patient Populations With Unresectable Stage III or IV Melanoma: CheckMate 401. J Clin Oncol. 2023 Aug 10;41(23):3917-3929. doi: 10.1200/JCO.22.02199. Epub 2023 Jun 12.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol Myers Squibb study director

Bristol-Myers Squibb

111 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 111 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in France, Australia, Germany, United Kingdom, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events (time frame: From first dose to 30 days after last dose (up to approximately 37 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02599402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.