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

Primary Purpose

Melanoma, Skin Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BMS-986205
Nivolumab
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Angeles Clinic and Research Institute
  • University Of Colorado
  • Mount Sinai Comprehensive Cancer Center
  • University Of Chicago
  • Oregon Health & Science University
  • Local Institution
  • Local Institution
  • Melanoma Institute Australia
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Klinika onkologie a radioterapie
  • Dermatovenerologicka klinika 3. LF UK a FNKV
  • Dermatovenerologicka klinika VFN a 1. LF UK
  • Local Institution
  • Local Institution
  • Local Institution
  • Elbe Klinikum Buxtehude
  • Universitaetsklinikum Carl Gustav Carus
  • Local Institution
  • SRH Wald-Kliniken Gera GmbH
  • Georg August Universitaet Goettingen
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Interbalkan European Medical Center
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Istituto Nazionale Tumori Fondazione Pascale
  • Azienda Ospedaliera Universitaria Senese
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Universitaetsspital Zuerich
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nivolumab + Placebo

Nivolumab + BMS-986205

Arm Description

Specified dose on specified day Participants will no longer receive BMS-986205 Placebo

Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 31, 2017
Last Updated
June 18, 2021
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03329846
Brief Title
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 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
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Skin Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab + Placebo
Arm Type
Active Comparator
Arm Description
Specified dose on specified day Participants will no longer receive BMS-986205 Placebo
Arm Title
Nivolumab + BMS-986205
Arm Type
Experimental
Arm Description
Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion
Intervention Type
Drug
Intervention Name(s)
BMS-986205
Intervention Description
specified dose on specified day
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Description
Specified dose on specified day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
BMS-986205 matching placebo
Intervention Description
Specified dose on specified day
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Adverse Events
Description
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
Time Frame
From first dose to 30 days following last dose (up to approximately 25 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 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 Exclusion Criteria: 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
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
Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Melanoma Institute Australia
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2146
Country
Australia
Facility Name
Local Institution
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Klinika onkologie a radioterapie
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Dermatovenerologicka klinika 3. LF UK a FNKV
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Dermatovenerologicka klinika VFN a 1. LF UK
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution
City
Boulogne-billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
Local Institution
City
Saint Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
Local Institution
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Elbe Klinikum Buxtehude
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
SRH Wald-Kliniken Gera GmbH
City
Gera
Country
Germany
Facility Name
Georg August Universitaet Goettingen
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Local Institution
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Interbalkan European Medical Center
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Local Institution
City
Dooradoyle
State/Province
Limerick
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
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Local Institution
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
9518566
Country
Japan
Facility Name
Local Institution
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7000914
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5418567
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Facility Name
Local Institution
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Local Institution
City
Christchurch
Country
New Zealand
Facility Name
Local Institution
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Santiago Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Universitaetsspital Zuerich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution
City
Belfast
ZIP/Postal Code
BT9 7AB
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
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Tauton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
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

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

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