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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02913313
Ethics application status
Date submitted
21/09/2016
Date registered
23/09/2016
Date last updated
12/05/2021

Titles & IDs
Public title
An Investigational Immuno-therapy Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Solid Cancers That Are Advanced or Have Spread
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
Other interventions - Nivolumab
Other interventions - Ipilimumab

Experimental: Part 1A: Dose Escalation Monotherapy (BMS-986207) -

Experimental: Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab) -

Experimental: Part 2A: Expansion Monotherapy (BMS-986207) -

Experimental: Part 2B: Expansion Combination Therapy (BMS-986207 + nivolumab) -

Experimental: Part 1C: Triplet Cohort (BMS-986207 + nivolumab + ipilimumab) -

Experimental: Part 2C: Triplet Expansion (BMS-986207 + nivolumab + ipilimumab) -


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

Other interventions: Nivolumab
Specified dose on specified days

Other interventions: Ipilimumab
Specified dose on specified days

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 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 15 months
Primary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 15 months
Primary outcome [3] 0 0
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Timepoint [3] 0 0
Up to 6 weeks
Primary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Up to 15 months
Primary outcome [5] 0 0
Incidence of deaths
Timepoint [5] 0 0
Up to 15 months
Primary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [6] 0 0
Up to 15 months
Primary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [7] 0 0
Up to 15 months
Primary outcome [8] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [8] 0 0
Up to 15 months
Primary outcome [9] 0 0
Objective response rate (ORR)
Timepoint [9] 0 0
Up to 36 months
Primary outcome [10] 0 0
Median duration of response (mDOR)
Timepoint [10] 0 0
Up to 36 months
Primary outcome [11] 0 0
Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Timepoint [11] 0 0
At 24 Weeks
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Median duration of response (mDOR)
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [3] 0 0
At 24 Weeks
Secondary outcome [4] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [4] 0 0
Up to 15 months
Secondary outcome [5] 0 0
Time of maximum observed serum concentration (Tmax)
Timepoint [5] 0 0
Up to 15 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)
Timepoint [6] 0 0
Up to 15 months
Secondary outcome [7] 0 0
Area under the concentration-time curve in one dosing interval AUC(TAU)
Timepoint [7] 0 0
Up to 15 months
Secondary outcome [8] 0 0
Observed concentration at the end of a dosing interval (Ctau)
Timepoint [8] 0 0
Up to 15 months
Secondary outcome [9] 0 0
Total body clearance (CLT)
Timepoint [9] 0 0
Up to 15 months
Secondary outcome [10] 0 0
Average concentration over a dosing interval (Css-avg)
Timepoint [10] 0 0
Up to 15 months
Secondary outcome [11] 0 0
Accumulation Index (AI)
Timepoint [11] 0 0
Up to 15 months
Secondary outcome [12] 0 0
Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff)
Timepoint [12] 0 0
Up to 15 months
Secondary outcome [13] 0 0
Trough observed serum concentrations (Ctrough)
Timepoint [13] 0 0
Up to 15 months
Secondary outcome [14] 0 0
Incidence of anti-drug antibody (ADA)
Timepoint [14] 0 0
Up to 15 months

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



- Participant must consent for pretreatment and on treatment tumor biopsy samples

- For Part 1C tumor biopsies are optional

- Nonsmall cell lung cancer (NSCLC) without prior treatment in the advanced or
metastatic setting (Part 2C)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Must have received, and progressed or been intolerant to, at least 1 standard
treatment regimen in the advanced or metastatic setting (Part 1A, 1B and 1C)

- 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
Gender
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/significant heart disease

- History of chronic hepatitis [except for hepatocellular carcinoma (HCC)]

- Active, known, or suspected autoimmune disease

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/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)
WA
Recruitment hospital [1] 0 0
Local Institution - 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
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Japan
State/province [6] 0 0
Chiba
Country [7] 0 0
Japan
State/province [7] 0 0
Tokyo
Country [8] 0 0
Romania
State/province [8] 0 0
Bucharest
Country [9] 0 0
Romania
State/province [9] 0 0
Cluj-Napoca
Country [10] 0 0
Romania
State/province [10] 0 0
Craiova
Country [11] 0 0
Romania
State/province [11] 0 0
Floresti/ Cluj

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02913313
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, please email:
Address 0 0
Country 0 0
Phone 0 0
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/NCT02913313