2017-08-08
2023-06-14
2023-06-14
332
NCT03184870
Bristol-Myers Squibb
Bristol-Myers Squibb
INTERVENTIONAL
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-06-09 | N/A | 2023-06-30 |
2017-06-09 | N/A | 2023-07-03 |
2017-06-14 | N/A | 2023-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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]) | DRUG: BMS-813160
DRUG: 5-fluorouracil (5-FU)
DRUG: Leucovorin
DRUG: Irinotecan
|
| EXPERIMENTAL: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel | DRUG: BMS-813160
DRUG: Nab-paclitaxel
DRUG: Gemcitabine
|
| 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 | BIOLOGICAL: Nivolumab
|
| EXPERIMENTAL: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI | DRUG: 5-fluorouracil (5-FU)
DRUG: Leucovorin
DRUG: Irinotecan
|
| EXPERIMENTAL: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI | DRUG: 5-fluorouracil (5-FU)
DRUG: Leucovorin
DRUG: Irinotecan
|
| EXPERIMENTAL: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI | |
| EXPERIMENTAL: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel | DRUG: Nab-paclitaxel
DRUG: Gemcitabine
|
| EXPERIMENTAL: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel | BIOLOGICAL: Nivolumab
|
| EXPERIMENTAL: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel | |
| EXPERIMENTAL: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab | BIOLOGICAL: 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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Adverse events (AEs) | Part 1 only | Approximately 4 years |
| Incidence of Serious adverse events (SAEs) | Part 1 only | Approximately 4 years |
| Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria | Part 1 only | Approximately 6 months |
| Incidence of AEs leading to discontinuation | Part 1 only | Approximately 4 years |
| Incidence of Death | Part 1 only | Approximately 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Part 1 only | Approximately 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Part 1 only | Approximately 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Part 1 only | Approximately 4 years |
| 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 |
| 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 |
| 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 |
| 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 |
| Incidence of clinically significant changes in vital signs: Body temperature | Part 1 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Part 1 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Pulse oximetry | Part 1 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Blood pressure | Part 1 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Heart rate | Part 1 only | Approximately 4 years |
| Decrease in regulatory T cells (Treg) or tumor-associated macrophage (TAM) in tumor samples | Part 1 only | Approximately 4 years |
| Overall response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Part 2 only | Approximately 2 years |
| Median duration of response (DOR) | Part 2 only | Approximately 2 years |
| Progression free survival (PFS) rate | Part 2 only | At 24 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Part 1 only | Approximately 2 years |
| Median duration of response (DOR) | Part 1 only | Approximately 2 years |
| Progression free survival (PFS) rate | Part 1 only | At 24 weeks |
| Maximum observed plasma concentration (Cmax) | Part 1 only | Approximately 4 years |
| Time of maximum observed plasma concentration (Tmax) | Part 1 only | Approximately 4 years |
| Trough observed plasma concentration (Ctrough) | Part 1 only | Approximately 4 years |
| Observed plasma concentration at 24 hours post dose (C24) | Part 1 only | Approximately 4 years |
| Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)] | Part 1 only | Approximately 4 years |
| Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)] | Part 1 only | Approximately 4 years |
| Apparent total body clearance (CLT/F) | Part 1 only | Approximately 4 years |
| 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 |
| Renal clearance (CLR) | Part 1 only | Approximately 4 years |
| Percent urinary recovery over 24 hours corrected for molecular weight (%UR) | Part 1 only | Approximately 4 years |
| Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax) | Part 1 only | Approximately 4 years |
| 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 |
| Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy | Part 1 only | Approximately 4 years |
| Incidence of Adverse events (AEs) | Part 2 only | Approximately 4 years |
| Incidence of Serious adverse events (SAEs) | Part 2 only | Approximately 4 years |
| Incidence of AEs leading to discontinuation | Part 2 only | Approximately 4 years |
| Incidence of Death | Part 2 only | Approximately 4 years |
| Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria | Part 2 Cohort 3b only | Approximately 6 months |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Part 2 only | Approximately 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Part 2 only | Approximately 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Part 2 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Body temperature | Part 2 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Part 2 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Pulse oximetry | Part 2 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Blood pressure | Part 2 only | Approximately 4 years |
| Incidence of clinically significant changes in vital signs: Heart rate | Part 2 only | Approximately 4 years |
| 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 |
| 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 |
| 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 |
| 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 |
| Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples | Part 2 only | Approximately 4 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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