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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/NCT03184870




Registration number
NCT03184870
Ethics application status
Date submitted
9/06/2017
Date registered
14/06/2017
Date last updated
3/07/2023

Titles & IDs
Public title
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
Scientific title
A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
2017-001725-40
Secondary ID [2] 0 0
CV202-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-813160
Other interventions - Nivolumab
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - 5-fluorouracil (5-FU)
Treatment: Drugs - Leucovorin
Treatment: Drugs - Irinotecan

Experimental: Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI - FOLFIRI: FOL (folinic acid [leucovorin]) F (fluorouracil [5-fluorouracil]) IRI (irinotecan [CAMPTOSAR])

Experimental: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel -

Experimental: Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab - 2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable

Experimental: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI -

Experimental: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI -

Experimental: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI -

Experimental: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel -

Experimental: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel -

Experimental: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel -

Experimental: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab -

Experimental: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab -

Experimental: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy -

Experimental: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy -


Treatment: Drugs: BMS-813160
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days

Treatment: Drugs: Nab-paclitaxel
Specified dose on specified days

Treatment: Drugs: Gemcitabine
Specified dose on specified days

Treatment: Drugs: 5-fluorouracil (5-FU)
Specified dose on specified days

Treatment: Drugs: Leucovorin
Specified dose on specified days

Treatment: Drugs: Irinotecan
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
Approximately 4 years
Primary outcome [2] 0 0
Incidence of Serious adverse events (SAEs)
Timepoint [2] 0 0
Approximately 4 years
Primary outcome [3] 0 0
Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Timepoint [3] 0 0
Approximately 6 months
Primary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Approximately 4 years
Primary outcome [5] 0 0
Incidence of Death
Timepoint [5] 0 0
Approximately 4 years
Primary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [6] 0 0
Approximately 4 years
Primary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [7] 0 0
Approximately 4 years
Primary outcome [8] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [8] 0 0
Approximately 4 years
Primary outcome [9] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Timepoint [9] 0 0
Approximately 4 years
Primary outcome [10] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Timepoint [10] 0 0
Approximately 4 years
Primary outcome [11] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Timepoint [11] 0 0
Approximately 4 years
Primary outcome [12] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Timepoint [12] 0 0
Approximately 4 years
Primary outcome [13] 0 0
Incidence of clinically significant changes in vital signs: Body temperature
Timepoint [13] 0 0
Approximately 4 years
Primary outcome [14] 0 0
Incidence of clinically significant changes in vital signs: Respiratory rate
Timepoint [14] 0 0
Approximately 4 years
Primary outcome [15] 0 0
Incidence of clinically significant changes in vital signs: Pulse oximetry
Timepoint [15] 0 0
Approximately 4 years
Primary outcome [16] 0 0
Incidence of clinically significant changes in vital signs: Blood pressure
Timepoint [16] 0 0
Approximately 4 years
Primary outcome [17] 0 0
Incidence of clinically significant changes in vital signs: Heart rate
Timepoint [17] 0 0
Approximately 4 years
Primary outcome [18] 0 0
Decrease in regulatory T cells (Treg) or tumor-associated macrophage (TAM) in tumor samples
Timepoint [18] 0 0
Approximately 4 years
Primary outcome [19] 0 0
Overall response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [19] 0 0
Approximately 2 years
Primary outcome [20] 0 0
Median duration of response (DOR)
Timepoint [20] 0 0
Approximately 2 years
Primary outcome [21] 0 0
Progression free survival (PFS) rate
Timepoint [21] 0 0
At 24 weeks
Secondary outcome [1] 0 0
Overall response rate (ORR)
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Median duration of response (DOR)
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Progression free survival (PFS) rate
Timepoint [3] 0 0
At 24 weeks
Secondary outcome [4] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [4] 0 0
Approximately 4 years
Secondary outcome [5] 0 0
Time of maximum observed plasma concentration (Tmax)
Timepoint [5] 0 0
Approximately 4 years
Secondary outcome [6] 0 0
Trough observed plasma concentration (Ctrough)
Timepoint [6] 0 0
Approximately 4 years
Secondary outcome [7] 0 0
Observed plasma concentration at 24 hours post dose (C24)
Timepoint [7] 0 0
Approximately 4 years
Secondary outcome [8] 0 0
Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)]
Timepoint [8] 0 0
Approximately 4 years
Secondary outcome [9] 0 0
Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)]
Timepoint [9] 0 0
Approximately 4 years
Secondary outcome [10] 0 0
Apparent total body clearance (CLT/F)
Timepoint [10] 0 0
Approximately 4 years
Secondary outcome [11] 0 0
Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI)
Timepoint [11] 0 0
Approximately 4 years
Secondary outcome [12] 0 0
Renal clearance (CLR)
Timepoint [12] 0 0
Approximately 4 years
Secondary outcome [13] 0 0
Percent urinary recovery over 24 hours corrected for molecular weight (%UR)
Timepoint [13] 0 0
Approximately 4 years
Secondary outcome [14] 0 0
Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax)
Timepoint [14] 0 0
Approximately 4 years
Secondary outcome [15] 0 0
Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)]
Timepoint [15] 0 0
Approximately 4 years
Secondary outcome [16] 0 0
Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy
Timepoint [16] 0 0
Approximately 4 years
Secondary outcome [17] 0 0
Incidence of Adverse events (AEs)
Timepoint [17] 0 0
Approximately 4 years
Secondary outcome [18] 0 0
Incidence of Serious adverse events (SAEs)
Timepoint [18] 0 0
Approximately 4 years
Secondary outcome [19] 0 0
Incidence of AEs leading to discontinuation
Timepoint [19] 0 0
Approximately 4 years
Secondary outcome [20] 0 0
Incidence of Death
Timepoint [20] 0 0
Approximately 4 years
Secondary outcome [21] 0 0
Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Timepoint [21] 0 0
Approximately 6 months
Secondary outcome [22] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [22] 0 0
Approximately 4 years
Secondary outcome [23] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [23] 0 0
Approximately 4 years
Secondary outcome [24] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [24] 0 0
Approximately 4 years
Secondary outcome [25] 0 0
Incidence of clinically significant changes in vital signs: Body temperature
Timepoint [25] 0 0
Approximately 4 years
Secondary outcome [26] 0 0
Incidence of clinically significant changes in vital signs: Respiratory rate
Timepoint [26] 0 0
Approximately 4 years
Secondary outcome [27] 0 0
Incidence of clinically significant changes in vital signs: Pulse oximetry
Timepoint [27] 0 0
Approximately 4 years
Secondary outcome [28] 0 0
Incidence of clinically significant changes in vital signs: Blood pressure
Timepoint [28] 0 0
Approximately 4 years
Secondary outcome [29] 0 0
Incidence of clinically significant changes in vital signs: Heart rate
Timepoint [29] 0 0
Approximately 4 years
Secondary outcome [30] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Timepoint [30] 0 0
Approximately 4 years
Secondary outcome [31] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Timepoint [31] 0 0
Approximately 4 years
Secondary outcome [32] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Timepoint [32] 0 0
Approximately 4 years
Secondary outcome [33] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Timepoint [33] 0 0
Approximately 4 years
Secondary outcome [34] 0 0
Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples
Timepoint [34] 0 0
Approximately 4 years

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



- Must have metastatic colorectal or pancreatic cancer

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

- Ability to swallow pills or capsules

- Required to undergo mandatory pre and on-treatment biopsies

- Adequate marrow function

- Adequate other organ functions

- Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and
pharmacodynamic (PD) sample collection, and required study follow-up
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Histology other than adenocarcinoma (neuroendocrine or acinar cell)

- Suspected, known, or central nervous system (CNS) metastases (Imaging required only if
participants are symptomatic)

- Active, known or suspected autoimmune disease

- Condition requiring systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalents) or other immunosuppressive medications within 14 days of study
treatment administration

- Interstitial lung disease that is symptomatic or may interfere with the detection or
management of suspected treatment-related pulmonary toxicity

- Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or
cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor
(PD-1), programmed death-ligand 1 [PD(L)-1] or cytotoxic T-lymphocyte antigen-4
(CTLA-4) antibodies

- History of allergy to study treatments or any of its components of the study arm that
participant is enrolling

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2023
Sample size
Target
Accrual to date
Final
332
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - 0028 - Clayton
Recruitment postcode(s) [1] 0 0
0 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles
Country [22] 0 0
Belgium
State/province [22] 0 0
Edegem
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Heidelberg
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Majadahonda - Madrid

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 evaluate the safety profile, tolerability, drug levels, drug
effects, and preliminary efficacy of BMS-813160 alone or in combination with either
chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic
colorectal and pancreatic cancers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03184870
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries