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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03363776




Registration number
NCT03363776
Ethics application status
Date submitted
1/12/2017
Date registered
6/12/2017
Date last updated
19/12/2020

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 Participants With an Adverse Event (AE)
Timepoint [1] 0 0
from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Primary outcome [2] 0 0
Number of Participants With a Serious Adverse Event (SAE)
Timepoint [2] 0 0
from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Primary outcome [3] 0 0
Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria
Timepoint [3] 0 0
from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Primary outcome [4] 0 0
Number of Participants With an Adverse Event (AE) Leading to Discontinuation
Timepoint [4] 0 0
from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Primary outcome [5] 0 0
Number of Participants With an Adverse Event (AE) Leading to Death
Timepoint [5] 0 0
from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Primary outcome [6] 0 0
Number of Participants With a Clinical Laboratory Test Abnormality
Timepoint [6] 0 0
from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Primary outcome [7] 0 0
Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers
Timepoint [7] 0 0
from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
at Weeks 8, 16 and 24
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
at Weeks 8, 16 and 24
Secondary outcome [3] 0 0
Median Duration of Response (mDOR)
Timepoint [3] 0 0
at Weeks 8, 16 and 24
Secondary outcome [4] 0 0
Median Progression-Free Survival (mPFS)
Timepoint [4] 0 0
at Weeks 8, 16 and 24, to progression
Secondary outcome [5] 0 0
Progression-Free Survival Rate (PFSR)
Timepoint [5] 0 0
at Weeks 8, 16 and 24
Secondary outcome [6] 0 0
Cmax
Timepoint [6] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [7] 0 0
Tmax
Timepoint [7] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [8] 0 0
AUC(0-T)
Timepoint [8] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [9] 0 0
AUC(INF)
Timepoint [9] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [10] 0 0
T-HALF
Timepoint [10] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [11] 0 0
CLT
Timepoint [11] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [12] 0 0
Vss
Timepoint [12] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [13] 0 0
Vz
Timepoint [13] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [14] 0 0
AUC(0-48)
Timepoint [14] 0 0
Cycle 1 (from time zero to 48 hours postdose)
Secondary outcome [15] 0 0
AUC(0-8)
Timepoint [15] 0 0
Cycle 1 (from time zero to 8 hours postdose)
Secondary outcome [16] 0 0
C48
Timepoint [16] 0 0
Cycle 1 at 48 hours postdose
Secondary outcome [17] 0 0
Css-avg
Timepoint [17] 0 0
Cycle 1 (from time zero to 48 hours postdose)
Secondary outcome [18] 0 0
AI_AUC
Timepoint [18] 0 0
Cycle 1 (Day 19, Day 15)
Secondary outcome [19] 0 0
AI_Cmax
Timepoint [19] 0 0
Cycle 1 (Day 19, Day 15)
Secondary outcome [20] 0 0
T-HALFeff
Timepoint [20] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [21] 0 0
Ctrough
Timepoint [21] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Secondary outcome [22] 0 0
Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response
Timepoint [22] 0 0
Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

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
Sex
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/11/2019
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
South Dakota
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario

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/ct2/show/NCT03363776
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03363776