MelanomaPhase 3NCT03329846

An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

A Phase 3 study testing BMS-986205 and Nivolumab in people with Melanoma and Skin Cancer, run by Bristol-Myers Squibb at 63 sites in 16 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Melanoma, Skin Cancer
What is being tested?: BMS-986205 and Nivolumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 63 sitesin 16 countries
Study dates: 30 Nov 2017to 2 Jul 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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

12 years and older unless not permitted by local regulations; in that case 18 years old and older
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
Measurable disease per RECIST v1.1

Who cannot join

Active brain metastases or leptomeningeal metastases
Uveal or ocular melanoma
Participants with active, known, or suspected autoimmune disease
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

63 sites in 16 countries.

Country

City, postcode or hospital

63 sites in 16 countries

Germany9 sites

Elbe Klinikum Buxtehude
Buxtehude, 21614
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Local Institution
Essen, 45147
SRH Wald-Kliniken Gera GmbH
Gera
Georg August Universitaet Goettingen
Göttingen, 37075
Local Institution
Hanover, 30625
Local Institution
Heidelberg, 69120
Local Institution
München, 80337
Local Institution
Tübingen, 72076

Other trials in Germany

Australia7 sites

Local Institution
Blacktown, New South Wales, 2148
Local Institution
Box Hill, Victoria, 3128
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Melbourne, Victoria, 3000
Local Institution
Melbourne, Victoria, 3004
Melanoma Institute Australia
North Sydney, New South Wales, 2146
Local Institution
Woolloongabba, Queensland, 4120

Other trials in Australia

United Kingdom7 sites

Local Institution
Belfast, BT9 7AB
Local Institution
Cambridge, CB2 0QQ
Local Institution
Cottingham, HU16 5JQ
Local Institution
London, Greater London, SW17 0RE
Local Institution
London, Greater London, SW3 6JJ
Local Institution
Manchester, M20 4BX
Local Institution
Tauton, TA1 5DA

Other trials in United Kingdom

United States6 sites

University Of Colorado
Aurora, Colorado, 80045
University Of Chicago
Chicago, Illinois, 60637
Angeles Clinic and Research Institute
Los Angeles, California, 90025
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Oregon Health & Science University
Portland, Oregon, 97239
Local Institution
Seattle, Washington, 98109

Other trials in United States

Spain6 sites

Local Institution
Barcelona, 08036
Local Institution
Jaén, 23007
Local Institution
Madrid, 28007
Local Institution
Málaga, 29010
Local Institution
Santiago Compostela, 15706
Local Institution
Valencia, 46026

Other trials in Spain

Japan5 sites

Local Institution
Chuo-ku, Tokyo, 1040045
Local Institution
Niigata, Niigata, 9518566
Local Institution
Okayama, Okayama-ken, 7000914
Local Institution
Osaka, Osaka, 5418567
Local Institution
Sendai, Miyagi, 9808574

Other trials in Japan

Netherlands4 sites

Local Institution
Amsterdam, 1066 CX
Local Institution
Groningen, 9700RB
Local Institution
Nijmegen, 6525 GA
Local Institution
Rotterdam, 3008 AE

Other trials in Netherlands

Czechia3 sites

Klinika onkologie a radioterapie
Hradec Králové, 500 05
Dermatovenerologicka klinika 3. LF UK a FNKV
Prague, 100 34
Dermatovenerologicka klinika VFN a 1. LF UK
Prague, 128 08

Other trials in Czechia

France3 sites

Local Institution
Boulogne-Billancourt, 92104
Local Institution
Saint-Etienne, 42055
Local Institution
Villejuif, 94805

Other trials in France

Ireland3 sites

Local Institution
Dooradoyle, Limerick
Local Institution
Dublin, 4
Local Institution
Dublin, 7

Other trials in Ireland

Italy3 sites

Local Institution
Milan, 20133
Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131
Azienda Ospedaliera Universitaria Senese
Siena, 53100

Other trials in Italy

Canada2 sites

Local Institution
Montreal, Quebec, H3T 1E2
Local Institution
Québec, Quebec, G1R 2J6

Other trials in Canada

New Zealand2 sites

Local Institution
Christchurch
Local Institution
Wellington, 6021

Other trials in New Zealand

Greece1 site

Interbalkan European Medical Center
Thessaloniki, 57001

Other trials in Greece

Poland1 site

Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, 02-781

Other trials in Poland

Switzerland1 site

Universitaetsspital Zuerich
Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated

Conditions: Melanoma, Skin Cancer
Being tested: BMS-986205, Nivolumab, Placebo
Medical subject headings: Melanoma, Skin Neoplasms

What participants receive

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

BMS-986205Drug
specified dose on specified day
NivolumabBiological
Also called BMS-936558
Specified dose on specified day
PlaceboDrug
Also called BMS-986205 matching placebo
Specified dose on specified day

Study groups in NCT03329846
Study group	Role	What they receive
Nivolumab + Placebo	Active comparator	Specified dose on specified day Participants will no longer receive BMS-986205 Placebo Receives: Biological: Nivolumab; Drug: Placebo
Nivolumab + BMS-986205	Experimental	Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion Receives: Drug: BMS-986205; Biological: Nivolumab

What is being measured

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

Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation
Measured: From first dose to 30 days following last dose (up to approximately 25 months)

Timeline

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

30 Nov 20172 Jul 2020

First posted6 Nov 2017
Study start30 Nov 2017
Primary completion2 Jul 2020
Study completion2 Jul 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.
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: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03329846
Sponsor's protocol ID: CA017-055
Other IDs: 2017-002499-14, 2017
Status last verified: Jun 2021
First submitted: 31 Oct 2017
Last updated: 9 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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 of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
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Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
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RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
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Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
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All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated
ClinicalTrials.gov ID: NCT03329846
Acronym / sponsor ID: CA017-055
Conditions: Melanoma, Skin Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 30 Nov 2017 (actual)
Primary completion: 2 Jul 2020 (actual)
Study completion: 2 Jul 2020 (actual)
First posted: 6 Nov 2017 (actual)
Results: Posted 9 Jul 2021

Clinical summary

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

Study design

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

Arm	Type	Receives
Nivolumab + Placebo	Active comparator	Biological: Nivolumab, Drug: PlaceboSpecified dose on specified day Participants will no longer receive BMS-986205 Placebo
Nivolumab + BMS-986205	Experimental	Drug: BMS-986205, Biological: NivolumabSpecified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

12 years and older unless not permitted by local regulations; in that case 18 years old and older
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
Measurable disease per RECIST v1.1

Key exclusion criteria (5 listed)

Active brain metastases or leptomeningeal metastases
Uveal or ocular melanoma
Participants with active, known, or suspected autoimmune disease
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
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
BMS-986205specified dose on specified day	Drug	Nivolumab + BMS-986205
NivolumabAlso: BMS-936558Specified dose on specified day	Biological	Nivolumab + BMS-986205, Nivolumab + Placebo
PlaceboAlso: BMS-986205 matching placeboSpecified dose on specified day	Drug	Nivolumab + Placebo

Primary outcome

Number of Participants Experiencing Adverse Events
Time frame: From first dose to 30 days following last dose (up to approximately 25 months)
Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation

Results and safety

Results posted to the registry on 9 Jul 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 + BMS-986205	10	2
Nivolumab	10	1

Primary outcome: Number of Participants Experiencing Adverse Events

Time frame: From first dose to 30 days following last dose (up to approximately 25 months). Count of participants. Unit: Participants

Measure	Nivolumab + BMS-986205 n = 10	Nivolumab n = 10
Deaths	0	0
Any cause SAEs (any grade)	3	3
Drug-related SAEs (any grade)	1	0
SAEs leading to discontinuation	1	0
Any cause AEs (any grade)	10	9
Drug-related AEs (any grade)	9	7
Drug-Related Non-serious AEs leading to discontinuation	0	0

Population analysed: All treated participants

Adverse events

Time frame: All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nivolumab + BMS-986205	4 of 10 (40%)	10 of 10 (100%)	1 of 10
Nivolumab	4 of 10 (40%)	9 of 10 (90%)	3 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Related trials for Melanoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

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

63 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BMS-986205 and Nivolumab in people with Melanoma and Skin Cancer, run by Bristol-Myers Squibb at 63 sites in 16 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 5 inclusion and 5 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 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Germany, Australia, United Kingdom, United States, Spain and 11 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 9 Jul 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?

Number of Participants Experiencing Adverse Events (time frame: From first dose to 30 days following last dose (up to approximately 25 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 NCT03329846.

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 9 Jul 2021.