MelanomaPhase 3NCT02714218
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
A Phase 3 study testing Nivolumab 3 mg/kg IV, Ipilimumab 1 mg/kg IV and Nivolumab 1 mg/kg IV in people with Melanoma, run by Bristol-Myers Squibb at 57 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of 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 3 mg/kg IV, Ipilimumab 1 mg/kg IV and Nivolumab 1 mg/kg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 57 sitesin 13 countries
- Study dates
- 4 Apr 2016to 28 May 2021
- 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
- Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Who cannot join
- Subjects with active brain metastases or leptomeningeal metastases
- Subjects with ocular melanoma
- Subjects with active, known or suspected autoimmune disease
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
57 sites in 13 countries.
57 sites in 13 countries
United States11 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University Of Colorado Cancer Center
Aurora, Colorado, 80045
Levine Cancer Institute
Charlotte, North Carolina, 28204
University Of Virginia Health System
Charlottesville, Virginia, 22908
Allina Health
Fridley, Minnesota, 55432
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University School Of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
France8 sites
Hopital Saint Andre
Bordeaux, 33075
Chru De Lille
Lille, 59037
Hopital De La Timone
Marseille, 13385
Hopital Hotel Dieu
Nantes, 44093
Hopital Saint Louis
Paris, 75475
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Institut Claudius Regaud
Toulouse, 31059
Local Institution - 0019
Villejuif, 94805
Italy6 sites
Local Institution - 0039
Bergamo, 24127
Local Institution - 0042
Milan, 20133
Local Institution - 0040
Naples, 80131
Istituto Oncologico Veneto IOV
Padova, 35128
Local Institution - 0041
Siena, 53100
Ospedale San Vincenzo
Taormina, 98039
Spain6 sites
Local Institution
Badalona-barcelona, 08916
Local Institution - 0024
Barcelona, 08036
Local Institution
Madrid, 28007
Local Institution - 0027
Madrid, 28034
Local Institution
San Sabastian Gipuzkoa, 20014
Local Institution
Valencia, 46014
Australia4 sites
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Melbourne, Victoria, 3004
Local Institution
North Sydney, New South Wales, 2060
Local Institution - 0045
Waratah, New South Wales, 2298
Germany4 sites
Universitaetsklinikum Essen
Essen, 45147
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Ludwig-Maximilians-Universitaet
München, 80337
Universitaetsklinikum Tuebingen
Tübingen, 72076
United Kingdom4 sites
Local Institution
Guildford, GU2 7XX
Local Institution
London, SW3 6JJ
Local Institution
Manchester, Greater Manchester, M20 4XB
Local Institution
Oxford, Oxfordshire, OX3 7LJ
Canada3 sites
Local Institution - 0007
Edmonton, Alberta, T6G 1Z2
CHU de Quebec - Universite Laval
Québec, Quebec, G1R 2J6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Denmark3 sites
Local Institution - 0063
Aarhus N, 8200
Local Institution - 0065
Herlev, 2730
Local Institution - 0064
Odense, 5000
Netherlands3 sites
Local Institution - 0052
Amsterdam, 1066 CX
Local Institution
Amsterdam, 1081 HV
University Medical Center Groningen (Umcg)
Groningen, 9700RB
Poland3 sites
Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote
Gdansk, 80-214
Klinika Nowotworow Ukladowych i Uogolnionych
Krakow, 31-115
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, 02-781
About this study
Official title: Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.
- Conditions
- Melanoma
- Being tested
- Nivolumab 3 mg/kg IV, Ipilimumab 1 mg/kg IV, Nivolumab 1 mg/kg IV, Ipilimumab 3 mg/kg IV, Nivolumab 6 mg/kg IV
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab 3 mg/kg IVBiological
Followed by Nivolumab monotherapy
Ipilimumab 1 mg/kg IVBiological
Followed by Nivolumab monotherapy
Nivolumab 1 mg/kg IVBiological
Ipilimumab 3 mg/kg IVBiological
Nivolumab 6 mg/kg IVBiological
A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to ~ 480mg.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV | Experimental | Specified dose on specified days Receives: Biological: Nivolumab 3 mg/kg IV; Biological: Ipilimumab 1 mg/kg IV |
| Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV | Experimental | Specified dose on specified days Receives: Biological: Nivolumab 1 mg/kg IV; Biological: Ipilimumab 3 mg/kg IV |
| Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg | Experimental | Specified dose on specified days Receives: Biological: Ipilimumab 1 mg/kg IV; Biological: Nivolumab 6 mg/kg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)
The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.
Measured: From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)
Secondary outcomes (18)
Objective Response Rate (ORR)
The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of progression per RECIST 1.1 or the date of subsequent anticancer therapy, whichever occurred first. For subjects without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Tumor assessments are scheduled at Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years)
Overall Survival (OS)
The time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Based on Kaplan-Meier Estimates.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years)
Progression Free Survival (PFS)
The time between the date of randomization and the first date of documented progression, determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. Those who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants without on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. Based on Kaplan-Meier Estimates. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years)
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Physical Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Role Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Emotional Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Cognitive Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Social Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Dyspnea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Insomnia sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Appetite loss sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Constipation sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Diarrhea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Financial difficulties sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Fatigue sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Nausea and Vomiting sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points for the various scales of the EORTC QLQ-C30
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Pain sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points
Measured: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start4 Apr 2016
- Primary completion20 Apr 2017
- Study completion28 May 2021
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 (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714218
- Sponsor's protocol ID
- CA209-511
- Status last verified
- Jun 2022
- First submitted
- 16 Mar 2016
- Last updated
- 24 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.
PubMed 39504507Lebbe C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.
PubMed 30811280
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT02714218
- Acronym / sponsor ID
- CA209-511
- Conditions
- Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 23 Apr 2019
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 evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV | Experimental | Biological: Nivolumab 3 mg/kg IV, Biological: Ipilimumab 1 mg/kg IVSpecified dose on specified days |
| Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV | Experimental | Biological: Nivolumab 1 mg/kg IV, Biological: Ipilimumab 3 mg/kg IVSpecified dose on specified days |
| Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg | Experimental | Biological: Ipilimumab 1 mg/kg IV, Biological: Nivolumab 6 mg/kg IVSpecified 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 (3 listed)
- Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Key exclusion criteria (4 listed)
- Subjects with active brain metastases or leptomeningeal metastases
- Subjects with ocular melanoma
- Subjects with active, known or suspected autoimmune disease
- Other protocol defined inclusion/exclusion criteria could apply
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 3 mg/kg IVFollowed by Nivolumab monotherapy | Biological | Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV |
| Ipilimumab 1 mg/kg IVFollowed by Nivolumab monotherapy | Biological | Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV, Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg |
| Nivolumab 1 mg/kg IV | Biological | Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV |
| Ipilimumab 3 mg/kg IV | Biological | Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV |
| Nivolumab 6 mg/kg IVA dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to ~ 480mg. | Biological | Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg |
Primary outcome
The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)
Time frame: From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)
The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.
18 secondary outcomes
Objective Response Rate (ORR)
Time frame: From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years)
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years)
Progression Free Survival (PFS)
Time frame: From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years)
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Time frame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39504507Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.
- Derived from this study: PubMed 30811280Lebbe C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.
- 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
57 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab 3 mg/kg IV, Ipilimumab 1 mg/kg IV and Nivolumab 1 mg/kg IV in people with Melanoma, run by Bristol-Myers Squibb at 57 sites in 13 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 3 inclusion and 4 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, France, Italy, Spain, Australia and 8 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 23 Apr 2019). 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?
The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) (time frame: From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 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 NCT02714218, which also lists 2 linked publications.
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 24 Jun 2022.