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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03110107




Registration number
NCT03110107
Ethics application status
Date submitted
7/04/2017
Date registered
12/04/2017
Date last updated
10/09/2020

Titles & IDs
Public title
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors
Scientific title
Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors
Secondary ID [1] 0 0
2017-000597-11
Secondary ID [2] 0 0
CA022-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ipilimumab
Other interventions - BMS-986218
Other interventions - Nivolumab

Experimental: Ipilimumab Monotherapy -

Experimental: Combination Therapy -

Experimental: BMS-986218 Monotherapy -


Other interventions: Ipilimumab
Specified dose on specified days

Other interventions: BMS-986218
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 4 years
Primary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 4 years
Primary outcome [3] 0 0
Objective Response Rate (ORR) of BMS-986218 monotherapy relative to Ipilimumab in immuno-oncology (IO) progressed melanoma cohort
Timepoint [3] 0 0
Up to 4 years
Primary outcome [4] 0 0
Median Duration of Response (mDOR) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort
Timepoint [4] 0 0
Up to 4 years
Primary outcome [5] 0 0
Progression Free Survival (PFS) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort
Timepoint [5] 0 0
Up to 4 years
Primary outcome [6] 0 0
Incidence of AEs meeting protocol- defined DLT criteria
Timepoint [6] 0 0
Up to 4 years
Primary outcome [7] 0 0
Incidence of AEs leading to discontinuation
Timepoint [7] 0 0
Up to 4 years
Primary outcome [8] 0 0
Incidence of death
Timepoint [8] 0 0
up to 4 years
Primary outcome [9] 0 0
Incidence of laboratory abnomalities
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [1] 0 0
ORR of BMS-986218 alone or in combination with Nivolumab
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
mDOR of BMS-986218 alone or in combination with Nivolumab
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
PFS of BMS-986218 alone or in combination with Nivolumab
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Incidence of anti-drug antibody (ADA) to BMS-986218
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Percentage of change from baseline in T-regulatory cells (Tregs)
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
Area under the concentration-time curve from time zero to the time of the
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
Trough observed serum concentration (Ctrough)
Timepoint [10] 0 0
Up to 4 years
Secondary outcome [11] 0 0
Total body clearance (CLT)
Timepoint [11] 0 0
Up to 4 years
Secondary outcome [12] 0 0
Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg)
Timepoint [12] 0 0
Up to 4 years
Secondary outcome [13] 0 0
Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)]
Timepoint [13] 0 0
Up to 4 years
Secondary outcome [14] 0 0
Terminal serum half-life if data permit (T-HALF)
Timepoint [14] 0 0
Up to 4 years
Secondary outcome [15] 0 0
Observed concentration at the end of a dosing interval (Ctau)
Timepoint [15] 0 0
Up to 4 years
Secondary outcome [16] 0 0
Time to deterioration (TTD) in Quality of Life and physical functioning
Timepoint [16] 0 0
Up to 4 years

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



- histologic or cytologic confirmation of a solid tumor that is advanced (metastatic,
recurrent and/or unresectable)

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Participants must have received, and then progressed, relapsed, or been intolerant to
at least 2 standard treatment regimens with proven survival benefit in the advanced or
metastatic setting according to tumor type, if such a therapy exists
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with primary CNS malignancies, or tumors with CNS metastases as the only
site of disease, will be excluded

- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior
anti-cancer therapy and initiation of study therapy

- Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or
immunotherapy (including anti-PD-1/PD-L1) are permitted

Other protocol defined inclusion/exclusion criteria could apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Local Institution - North Sydney
Recruitment hospital [2] 0 0
Local Institution - Westmead
Recruitment hospital [3] 0 0
Local Institution - Murdoch
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Dakota
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Caba
Country [11] 0 0
Argentina
State/province [11] 0 0
Cordoba
Country [12] 0 0
Argentina
State/province [12] 0 0
Cuiudad Autonoma De Buenos Aires
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Chile
State/province [18] 0 0
Metropolitana
Country [19] 0 0
Chile
State/province [19] 0 0
Valparaiso
Country [20] 0 0
Chile
State/province [20] 0 0
Santiago
Country [21] 0 0
Denmark
State/province [21] 0 0
Copenhagen
Country [22] 0 0
Finland
State/province [22] 0 0
Helsinki
Country [23] 0 0
France
State/province [23] 0 0
Lyon Cedex 08
Country [24] 0 0
France
State/province [24] 0 0
Toulouse Cedex 9
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Israel
State/province [28] 0 0
Haifa
Country [29] 0 0
Israel
State/province [29] 0 0
Ramat Gan
Country [30] 0 0
Italy
State/province [30] 0 0
Napoli
Country [31] 0 0
Italy
State/province [31] 0 0
Siena
Country [32] 0 0
Netherlands
State/province [32] 0 0
Amsterdam
Country [33] 0 0
Netherlands
State/province [33] 0 0
Nijmegen
Country [34] 0 0
Norway
State/province [34] 0 0
Oslo
Country [35] 0 0
Poland
State/province [35] 0 0
Mazowieckie
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Malaga
Country [39] 0 0
Spain
State/province [39] 0 0
Pamplona
Country [40] 0 0
Switzerland
State/province [40] 0 0
Lausanne
Country [41] 0 0
Switzerland
State/province [41] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in
combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Trial website
https://clinicaltrials.gov/show/NCT03110107
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03110107