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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03363776




Registration number
NCT03363776
Ethics application status
Date submitted
1/12/2017
Date registered
6/12/2017
Date last updated
2/04/2019

Titles & IDs
Public title
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers
Scientific title
Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors
Secondary ID [1] 0 0
2017-002199-24
Secondary ID [2] 0 0
CA034-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BMS-986277
Other interventions - Nivolumab

Experimental: Monotherapy - BMS-986277 administered alone

Experimental: Combination Dose Escalation Therapy - BMS-986277 administered in combination with Nivolumab

Experimental: Combination Expansion Therapy - BMS-986277 monotherapy with option for subsequent Nivolumab therapy


Other interventions: BMS-986277
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
Number of adverse events (AE)
Timepoint [1] 0 0
Up to 842 days
Primary outcome [2] 0 0
Number of serious adverse events (SAE)
Timepoint [2] 0 0
Up to 842 days
Primary outcome [3] 0 0
Number of AEs meeting dose limiting toxities criteria
Timepoint [3] 0 0
Up to 842 days
Primary outcome [4] 0 0
Number of AEs leading to discontinuation
Timepoint [4] 0 0
Up to 842 days
Primary outcome [5] 0 0
Number of AEs resulting in death
Timepoint [5] 0 0
Up to 842 days
Primary outcome [6] 0 0
Incidence of clinical laboratory test abnormalities
Timepoint [6] 0 0
Up to 842 days
Primary outcome [7] 0 0
Incidence of vital sign abnormalities
Timepoint [7] 0 0
Up to 842 days
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Median duration of response (mDOR)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Median progression-free survival (mPFS)
Timepoint [4] 0 0
Up to 24 weeks
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Up to 24 weeks
Secondary outcome [6] 0 0
Maximum observed blood concentration (Cmax)
Timepoint [6] 0 0
Up to 92 days
Secondary outcome [7] 0 0
Time of maximum observed blood concentration (Tmax)
Timepoint [7] 0 0
Up to 92 days
Secondary outcome [8] 0 0
Area under the blood concentration-time curve from time zero to time of last quanitifiable concentration [AUC(0-T)]
Timepoint [8] 0 0
Up to 92 days
Secondary outcome [9] 0 0
Area under the blood concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Timepoint [9] 0 0
Up to 92 days
Secondary outcome [10] 0 0
Apparent terminal half-life (T-HALF)
Timepoint [10] 0 0
Up to 92 days
Secondary outcome [11] 0 0
Total body clearance (CLT)
Timepoint [11] 0 0
Up to 92 days
Secondary outcome [12] 0 0
Volume of distribution at steady-state (Vss)
Timepoint [12] 0 0
Up to 92 days
Secondary outcome [13] 0 0
Volume of distribution of the elimination phase (Vz)
Timepoint [13] 0 0
Up to 92 days
Secondary outcome [14] 0 0
Average plasma concentration over a dosing interval (AUC[0-48]/48) (Css-avg)
Timepoint [14] 0 0
Up to 92 days

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



- Histological or cytological confirmation of metastatic and/or unresectable metastatic
colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with
measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per
PCWG3

- Presence of at least 2 lesions: at least one with measurable disease as defined by
RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response
assessment; at least 1 lesion must be accessible for biopsy in addition to the target
lesion

- Participants must have received, and then progressed or been intolerant to, at least 1
standard treatment regimen in the advanced or metastatic setting, if such a therapy
exists, and have been considered for all other potentially efficacious therapies prior
to enrollment

- ECOG performance status less than or equal to 2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with active central nervous system (CNS) metastases, untreated CNS
metastases, or with the CNS as the only site of disease

- Participants with carcinomatous meningitis

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

- Participants with active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could 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)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Herston
Recruitment hospital [3] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
South Dakota
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Spain
State/province [8] 0 0
Pamplona

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 investigate experimental medication BMS-986277 given alone
and in combination with Nivolumab in patients with epithelial cancers.
Trial website
https://clinicaltrials.gov/show/NCT03363776
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/NCT03363776