A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

Colorectal Cancer Clinical Trial

Official title:

A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184870
• Other study ID #: CV202-103
• Secondary ID: 2017-001725-40
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 8, 2017
• Est. completion date: June 14, 2023

Study information

• Verified date: June 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Pancreatic Cancer

Intervention

Drug:
• BMS-813160
Specified dose on specified days

Biological:
• Nivolumab
Specified dose on specified days

Drug:
• Nab-paclitaxel
Specified dose on specified days
• Gemcitabine
Specified dose on specified days
• 5-fluorouracil (5-FU)
Specified dose on specified days
• Leucovorin
Specified dose on specified days
• Irinotecan
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0028	Clayton	Victoria
Belgium	Local Institution - 0050	Bruxelles
Belgium	Local Institution - 0051	Edegem
Belgium	Local Institution - 0049	Leuven
Canada	Local Institution - 0013	Edmonton	Alberta
Canada	Local Institution - 0012	Ottawa	Ontario
Canada	Local Institution - 0001	Toronto	Ontario
Germany	Local Institution - 0022	Dresden
Germany	Local Institution - 0007	Heidelberg
Spain	Local Institution - 0031	Barcelona
Spain	Local Institution - 0032	Madrid
Spain	Local Institution - 0030	Majadahonda - Madrid
United States	Local Institution - 0037	Allentown	Pennsylvania
United States	Local Institution - 0015	Aurora	Colorado
United States	Local Institution - 0005	Baltimore	Maryland
United States	Local Institution - 0003	Birmingham	Alabama
United States	Local Institution - 0033	Boston	Massachusetts
United States	Local Institution - 0048	Brooksville	Florida
United States	Local Institution - 0045	Charleston	South Carolina
United States	Local Institution - 0046	Charlotte	North Carolina
United States	Local Institution - 0042	Charlottesville	Virginia
United States	Local Institution - 0021	Cleveland	Ohio
United States	Local Institution - 0044	Cleveland	Ohio
United States	Local Institution - 0004	Hackensack	New Jersey
United States	Local Institution - 0039	Hattiesburg	Mississippi
United States	Local Institution - 0002	Los Angeles	California
United States	Local Institution - 0025	Los Angeles	California
United States	Local Institution - 0034	Nashville	Tennessee
United States	Local Institution - 0038	Nashville	Tennessee
United States	Local Institution - 0017	New York	New York
United States	Local Institution - 0041	Orange	California
United States	Local Institution - 0014	Philadelphia	Pennsylvania
United States	Local Institution - 0020	Philadelphia	Pennsylvania
United States	Local Institution - 0026	Phoenix	Arizona
United States	Local Institution - 0024	Rochester	New York
United States	Local Institution - 0027	Rochester	Minnesota
United States	Local Institution - 0023	Saint Louis	Missouri
United States	Local Institution - 0047	Saint Petersburg	Florida
United States	Local Institution - 0016	Salt Lake City	Utah
United States	Local Institution - 0018	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse events (AEs)	Part 1 only	Approximately 4 years
Primary	Incidence of Serious adverse events (SAEs)	Part 1 only	Approximately 4 years
Primary	Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria	Part 1 only	Approximately 6 months
Primary	Incidence of AEs leading to discontinuation	Part 1 only	Approximately 4 years
Primary	Incidence of Death	Part 1 only	Approximately 4 years
Primary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Part 1 only	Approximately 4 years
Primary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests	Part 1 only	Approximately 4 years
Primary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Part 1 only	Approximately 4 years
Primary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	Part 1 only PR interval: The time from the onset of the P wave to the start of the QRS complex	Approximately 4 years
Primary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval	Part 1 only QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization	Approximately 4 years
Primary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	Part 1 only QT interval: Measured from the beginning of the QRS complex to the end of the T wave	Approximately 4 years
Primary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval	Part 1 only QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)	Approximately 4 years
Primary	Incidence of clinically significant changes in vital signs: Body temperature	Part 1 only	Approximately 4 years
Primary	Incidence of clinically significant changes in vital signs: Respiratory rate	Part 1 only	Approximately 4 years
Primary	Incidence of clinically significant changes in vital signs: Pulse oximetry	Part 1 only	Approximately 4 years
Primary	Incidence of clinically significant changes in vital signs: Blood pressure	Part 1 only	Approximately 4 years
Primary	Incidence of clinically significant changes in vital signs: Heart rate	Part 1 only	Approximately 4 years
Primary	Decrease in regulatory T cells (Treg) or tumor-associated macrophage (TAM) in tumor samples	Part 1 only	Approximately 4 years
Primary	Overall response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Part 2 only	Approximately 2 years
Primary	Median duration of response (DOR)	Part 2 only	Approximately 2 years
Primary	Progression free survival (PFS) rate	Part 2 only	At 24 weeks
Secondary	Overall response rate (ORR)	Part 1 only	Approximately 2 years
Secondary	Median duration of response (DOR)	Part 1 only	Approximately 2 years
Secondary	Progression free survival (PFS) rate	Part 1 only	At 24 weeks
Secondary	Maximum observed plasma concentration (Cmax)	Part 1 only	Approximately 4 years
Secondary	Time of maximum observed plasma concentration (Tmax)	Part 1 only	Approximately 4 years
Secondary	Trough observed plasma concentration (Ctrough)	Part 1 only	Approximately 4 years
Secondary	Observed plasma concentration at 24 hours post dose (C24)	Part 1 only	Approximately 4 years
Secondary	Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)]	Part 1 only	Approximately 4 years
Secondary	Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)]	Part 1 only	Approximately 4 years
Secondary	Apparent total body clearance (CLT/F)	Part 1 only	Approximately 4 years
Secondary	Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI)	Part 1 only	Approximately 4 years
Secondary	Renal clearance (CLR)	Part 1 only	Approximately 4 years
Secondary	Percent urinary recovery over 24 hours corrected for molecular weight (%UR)	Part 1 only	Approximately 4 years
Secondary	Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax)	Part 1 only	Approximately 4 years
Secondary	Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)]	Part 1 only	Approximately 4 years
Secondary	Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy	Part 1 only	Approximately 4 years
Secondary	Incidence of Adverse events (AEs)	Part 2 only	Approximately 4 years
Secondary	Incidence of Serious adverse events (SAEs)	Part 2 only	Approximately 4 years
Secondary	Incidence of AEs leading to discontinuation	Part 2 only	Approximately 4 years
Secondary	Incidence of Death	Part 2 only	Approximately 4 years
Secondary	Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria	Part 2 Cohort 3b only	Approximately 6 months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Part 2 only	Approximately 4 years
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests	Part 2 only	Approximately 4 years
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Part 2 only	Approximately 4 years
Secondary	Incidence of clinically significant changes in vital signs: Body temperature	Part 2 only	Approximately 4 years
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate	Part 2 only	Approximately 4 years
Secondary	Incidence of clinically significant changes in vital signs: Pulse oximetry	Part 2 only	Approximately 4 years
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure	Part 2 only	Approximately 4 years
Secondary	Incidence of clinically significant changes in vital signs: Heart rate	Part 2 only	Approximately 4 years
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	Part 2 only PR interval: The time from the onset of the P wave to the start of the QRS complex	Approximately 4 years
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval	Part 2 only QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization	Approximately 4 years
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	Part 2 only QT interval: Measured from the beginning of the QRS complex to the end of the T wave	Approximately 4 years
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval	Part 2 only QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)	Approximately 4 years
Secondary	Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples	Part 2 only	Approximately 4 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting