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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02913313




Registration number
NCT02913313
Ethics application status
Date submitted
21/09/2016
Date registered
23/09/2016
Date last updated
3/04/2024

Titles & IDs
Public title
A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
Scientific title
Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
Secondary ID [1] 0 0
2016-002263-34
Secondary ID [2] 0 0
CA020-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Broad Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986207
Treatment: Other - Nivolumab
Treatment: Other - Ipilimumab

Experimental: Part 1A: Dose Escalation Monotherapy -

Experimental: Part 1B: Dose Escalation Combination Therapy -

Experimental: Part 2A: Expansion Monotherapy -

Experimental: Part 2B: Expansion Combination Therapy -

Experimental: Part 1C: Triplet Cohort -

Experimental: Part 2C: Triplet Expansion -


Treatment: Drugs: BMS-986207
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Other: Ipilimumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to 27 months
Primary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Assessment method [2] 0 0
Timepoint [2] 0 0
Up to 27 months
Primary outcome [3] 0 0
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Assessment method [3] 0 0
Timepoint [3] 0 0
Up to 6 weeks
Primary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Assessment method [4] 0 0
Timepoint [4] 0 0
Up to 27 months
Primary outcome [5] 0 0
Incidence of deaths
Assessment method [5] 0 0
Timepoint [5] 0 0
Up to 27 months
Primary outcome [6] 0 0
Number of participants with laboratory abnormalities
Assessment method [6] 0 0
Timepoint [6] 0 0
Up to 27 months
Primary outcome [7] 0 0
Objective response rate (ORR)
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to 36 months
Primary outcome [8] 0 0
Median duration of response (mDOR)
Assessment method [8] 0 0
Timepoint [8] 0 0
Up to 36 months
Primary outcome [9] 0 0
Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Assessment method [9] 0 0
Timepoint [9] 0 0
At 24 weeks
Secondary outcome [1] 0 0
Objective response rate (ORR)
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Median duration of response (mDOR)
Assessment method [2] 0 0
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1
Assessment method [3] 0 0
Timepoint [3] 0 0
At 24 Weeks
Secondary outcome [4] 0 0
Maximum observed serum concentration (Cmax)
Assessment method [4] 0 0
Timepoint [4] 0 0
Up to 27 months
Secondary outcome [5] 0 0
Time of maximum observed serum concentration (Tmax)
Assessment method [5] 0 0
Timepoint [5] 0 0
Up to 27 months
Secondary outcome [6] 0 0
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Assessment method [6] 0 0
Timepoint [6] 0 0
Up to 27 months
Secondary outcome [7] 0 0
Incidence of anti-drug antibody (ADA)
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to 27 months

Eligibility
Key inclusion criteria
* Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive = 1% for a participant to be eligible for enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll
* Other active malignancy requiring concurrent intervention
* Uncontrolled or significant cardiovascular disease
* Active, known, or suspected autoimmune disease
* NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/01/2024
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Local Institution - 0006 - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad Autónoma De Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Cordoba
Country [7] 0 0
Argentina
State/province [7] 0 0
Distrito Federal
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Chile
State/province [9] 0 0
Metropolitana
Country [10] 0 0
Japan
State/province [10] 0 0
Chiba
Country [11] 0 0
Japan
State/province [11] 0 0
Tokyo
Country [12] 0 0
Romania
State/province [12] 0 0
Bucharest
Country [13] 0 0
Romania
State/province [13] 0 0
Cluj
Country [14] 0 0
Romania
State/province [14] 0 0
Craiova
Country [15] 0 0
Romania
State/province [15] 0 0
Flore?ti
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02913313