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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03110107
Ethics application status
Date submitted
7/04/2017
Date registered
12/04/2017
Date last updated
24/04/2025

Titles & IDs
Public title
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants 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
Treatment: Other - Ipilimumab
Treatment: Other - BMS-986218
Treatment: Other - Nivolumab

Experimental: Part 1A: Monotherapy (BMS-986218) -

Experimental: Part 1B: Combination Therapy (BMS-986218 + Nivolumab) -

Experimental: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab) -

Experimental: Part 2B: Monotherapy (BMS-986218) -

Experimental: Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab) -

Experimental: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab) -


Treatment: Other: Ipilimumab
Specified dose on specified days

Treatment: Other: BMS-986218
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Primary outcome [3] 0 0
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Timepoint [3] 0 0
From first dose of study medication through 60 days following last dose of study treatment (assessed for an average of 7 months up to a max of approximately 27 months)
Primary outcome [4] 0 0
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Timepoint [4] 0 0
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Primary outcome [5] 0 0
Number of Participants Who Died
Timepoint [5] 0 0
From randomization (Part 2A and 2B) or first dose (Part 1, 2C and 2D) until study closure (Up to approximately 83 months)
Primary outcome [6] 0 0
Objective Response Rate (ORR) for Part 2 Only
Timepoint [6] 0 0
From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)
Primary outcome [7] 0 0
Median Duration of Response (mDOR) for Part 2 Only
Timepoint [7] 0 0
From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)
Primary outcome [8] 0 0
Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only
Timepoint [8] 0 0
At 24, 36, and 48 weeks
Secondary outcome [1] 0 0
Objective Response Rate (ORR) for Part1A and Part1B Only
Timepoint [1] 0 0
From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)
Secondary outcome [2] 0 0
Median Duration of Response (mDOR) for Part1A and Part1B Only
Timepoint [2] 0 0
From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)
Secondary outcome [3] 0 0
Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only
Timepoint [3] 0 0
At 24, 36, and 48 weeks
Secondary outcome [4] 0 0
Maximum Observed Serum Concentration (Cmax) for BMS-986218
Timepoint [4] 0 0
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Secondary outcome [5] 0 0
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218
Timepoint [5] 0 0
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Secondary outcome [6] 0 0
Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218
Timepoint [6] 0 0
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Secondary outcome [7] 0 0
Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218
Timepoint [7] 0 0
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Secondary outcome [8] 0 0
Total Body Clearance (CLT/F) for BMS-986218
Timepoint [8] 0 0
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Secondary outcome [9] 0 0
Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218
Timepoint [9] 0 0
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Secondary outcome [10] 0 0
Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218
Timepoint [10] 0 0
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Secondary outcome [11] 0 0
Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218
Timepoint [11] 0 0
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Secondary outcome [12] 0 0
Terminal Serum Half-life (T-HALF) for BMS-986218
Timepoint [12] 0 0
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Secondary outcome [13] 0 0
Time of Maximum Observed Concentration (Tmax) for BMS-986218
Timepoint [13] 0 0
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Secondary outcome [14] 0 0
Trough Observed Plasma Concentration (Ctrough) for BMS-986218
Timepoint [14] 0 0
At Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1 (Each Cycle is of 28 Days)
Secondary outcome [15] 0 0
Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218
Timepoint [15] 0 0
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)

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
* Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
* Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B & 2C)
* Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)
Minimum age
18 Years
Maximum age
No limit
Sex
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 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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/04/2024
Sample size
Target
Accrual to date
Final
376
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Local Institution - 0026 - Northmead
Recruitment hospital [2] 0 0
Local Institution - 0006 - Wollstonecraft
Recruitment hospital [3] 0 0
Local Institution - 0049 - Murdoch
Recruitment postcode(s) [1] 0 0
2152 - Northmead
Recruitment postcode(s) [2] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
South Dakota
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Ciudad Autónoma De Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Cordoba
Country [10] 0 0
Argentina
State/province [10] 0 0
Distrito Federal
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Chile
State/province [15] 0 0
Metropolitana
Country [16] 0 0
Chile
State/province [16] 0 0
Valparaiso
Country [17] 0 0
Finland
State/province [17] 0 0
Helsinki
Country [18] 0 0
France
State/province [18] 0 0
Lyon Cedex 08
Country [19] 0 0
France
State/province [19] 0 0
Toulouse Cedex 9
Country [20] 0 0
France
State/province [20] 0 0
Villejuif
Country [21] 0 0
Germany
State/province [21] 0 0
Dresden
Country [22] 0 0
Germany
State/province [22] 0 0
Essen
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Ramat Gan
Country [25] 0 0
Italy
State/province [25] 0 0
Napoli
Country [26] 0 0
Italy
State/province [26] 0 0
Rozzano
Country [27] 0 0
Italy
State/province [27] 0 0
Siena
Country [28] 0 0
Netherlands
State/province [28] 0 0
Amsterdam
Country [29] 0 0
Netherlands
State/province [29] 0 0
Nijmegen
Country [30] 0 0
Norway
State/province [30] 0 0
Oslo
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Romania
State/province [32] 0 0
Cluj Napoca
Country [33] 0 0
Romania
State/province [33] 0 0
Craiova
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Malaga
Country [37] 0 0
Spain
State/province [37] 0 0
Pamplona
Country [38] 0 0
Switzerland
State/province [38] 0 0
Lausanne
Country [39] 0 0
Switzerland
State/province [39] 0 0
Zuerich

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03110107