Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
20/04/2025
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
Query!
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
Query!
Secondary ID [1]
0
0
2016-002263-34
Query!
Secondary ID [2]
0
0
CA020-002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Broad Solid Tumor
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Adverse Events
Query!
Assessment method [1]
0
0
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
Query!
Timepoint [1]
0
0
From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)
Query!
Primary outcome [2]
0
0
Number of Participants Who Died
Query!
Assessment method [2]
0
0
Participants who died with any cause are considered in the analysis.
Query!
Timepoint [2]
0
0
From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)
Query!
Primary outcome [3]
0
0
Part 1A, 1B and 1C and 2A: Number of Participants With Dose Limiting Toxicities
Query!
Assessment method [3]
0
0
Criteria for Dose-Limiting Toxicities (DLTs): Hepatic DLTs (excluding HCC): Grade (Gr) 4 elevations in AST, ALT, ALP, or total bilirubin. Gr 3 elevations in AST, ALT, or ALP \>5 days, with symptoms, or bilirubin \>2xULN without cholestasis. Gr 2 AST or ALT with symptomatic liver inflammation. AST or ALT \>3xULN and bilirubin \>2xULN without cholestasis. Hepatic DLTs for HCC: AST or ALT \>10xULN for \>2 weeks. AST or ALT \>15xULN. Total bilirubin \>8xULN (elevated at entry) or \>5xULN (normal at entry). ALT =10xULN and bilirubin =2xULN or baseline, without other causes. Hematologic DLTs: Gr 4 neutropenia =7 days. Gr 4 thrombocytopenia. Gr 3 thrombocytopenia with bleeding or platelet transfusion. Febrile neutropenia. Gr 3 hemolysis requiring intervention. Gr 4 anemia not due to underlying disease. Dermatologic DLTs: Gr 4 rash. Gr 3 rash not improving to =Gr 1 after 1-2 week delay. Other DLTs: Gr 2-4 eye issues, Gr 3-4 toxicities, excluding specific Gr 3 events like nausea, fever.
Query!
Timepoint [3]
0
0
From first dose (Day 1) and up to 6 weeks
Query!
Primary outcome [4]
0
0
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
Query!
Assessment method [4]
0
0
Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.
Query!
Timepoint [4]
0
0
From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)
Query!
Primary outcome [5]
0
0
Part 2C: Objective Response Rate (ORR)
Query!
Assessment method [5]
0
0
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Query!
Timepoint [5]
0
0
From first dose (Day 1) and up to 24 weeks
Query!
Primary outcome [6]
0
0
Part 2C: Duration of Response (DOR)
Query!
Assessment method [6]
0
0
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Query!
Timepoint [6]
0
0
From first dose (Day 1) and up to 24 weeks
Query!
Primary outcome [7]
0
0
Part 2C: Progression Free Survival Rate at Week 24
Query!
Assessment method [7]
0
0
Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Query!
Timepoint [7]
0
0
Week 24
Query!
Secondary outcome [1]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [1]
0
0
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
Query!
Timepoint [1]
0
0
From first dose (Day 1) and up to 24 weeks
Query!
Secondary outcome [2]
0
0
Duration of Response
Query!
Assessment method [2]
0
0
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Query!
Timepoint [2]
0
0
From first dose (Day 1) and up to 24 weeks
Query!
Secondary outcome [3]
0
0
Progression Free Survival Rate at Week 24
Query!
Assessment method [3]
0
0
Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Query!
Timepoint [3]
0
0
Week 24
Query!
Secondary outcome [4]
0
0
Maximum Observed Concentration (Cmax) of BMS-986207
Query!
Assessment method [4]
0
0
Cmax is defined as maximum plasma concentration of the drug.
Query!
Timepoint [4]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [5]
0
0
BMS-986207 Time to Maximum Concentration (Tmax)
Query!
Assessment method [5]
0
0
Time to observed maximum concentration (Tmax) is defined as the amount of time in hours for a drug to reach the maximum concentration after administration.
Query!
Timepoint [5]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [6]
0
0
BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
Query!
Assessment method [6]
0
0
BMS-986207 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).
Query!
Timepoint [6]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [7]
0
0
BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Query!
Assessment method [7]
0
0
Blood samples were collected for assessing AUC (TAU).
Query!
Timepoint [7]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [8]
0
0
BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Query!
Assessment method [8]
0
0
Blood samples were collected for assessing Ctau.
Query!
Timepoint [8]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [9]
0
0
BMS-986207 Total Body Clearance (CLT)
Query!
Assessment method [9]
0
0
Blood samples were collected for assessing CLT.
Query!
Timepoint [9]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [10]
0
0
BMS-986207 Average Concentration Over a Dosing Interval (Css-avg)
Query!
Assessment method [10]
0
0
Blood samples were collected for assessing Css-avg.
Query!
Timepoint [10]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [11]
0
0
BMS-986207 Ratio of an Exposure Measure at Steady State to That After the First Dose (AI_TAU)
Query!
Assessment method [11]
0
0
Blood samples were collected for assessing AI_TAU.
Query!
Timepoint [11]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [12]
0
0
BMS-986207 Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (T-HALFeff)
Query!
Assessment method [12]
0
0
Blood samples were collected for assessing T-HALFeff. Exposure measure includes AUC\[TAU\].
Query!
Timepoint [12]
0
0
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Query!
Secondary outcome [13]
0
0
Number of Participants With Positive Anti-BMS-986207-Antibodies Results
Query!
Assessment method [13]
0
0
Participants who were treated with BMS-986207 and at least one post-baseline evaluable ADA assessment were considered in the analysis
Query!
Timepoint [13]
0
0
From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/11/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
25/01/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
101
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment hospital [1]
0
0
Local Institution - 0006 - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
New Jersey
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
New York
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Pennsylvania
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Utah
Query!
Country [5]
0
0
Argentina
Query!
State/province [5]
0
0
Ciudad Autónoma De Buenos Aires
Query!
Country [6]
0
0
Argentina
Query!
State/province [6]
0
0
Cordoba
Query!
Country [7]
0
0
Argentina
Query!
State/province [7]
0
0
Distrito Federal
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Ontario
Query!
Country [9]
0
0
Chile
Query!
State/province [9]
0
0
Metropolitana
Query!
Country [10]
0
0
Japan
Query!
State/province [10]
0
0
Chiba
Query!
Country [11]
0
0
Japan
Query!
State/province [11]
0
0
Tokyo
Query!
Country [12]
0
0
Romania
Query!
State/province [12]
0
0
Bucharest
Query!
Country [13]
0
0
Romania
Query!
State/province [13]
0
0
Cluj
Query!
Country [14]
0
0
Romania
Query!
State/province [14]
0
0
Craiova
Query!
Country [15]
0
0
Romania
Query!
State/province [15]
0
0
Flore?ti
Query!
Country [16]
0
0
Singapore
Query!
State/province [16]
0
0
Singapore
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Ono Pharmaceutical Co. Ltd
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02913313
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/13/NCT02913313/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/13/NCT02913313/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02913313
Download to PDF