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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - 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

Treatment: Other: 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
Treatment: Other
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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03184870