A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03184870 |
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Recruitment Status :
Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : April 20, 2021
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer Pancreatic Cancer | Drug: BMS-813160 Biological: Nivolumab Drug: Nab-paclitaxel Drug: Gemcitabine Drug: 5-fluorouracil (5-FU) Drug: Leucovorin Drug: Irinotecan | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 332 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors |
| Actual Study Start Date : | August 8, 2017 |
| Estimated Primary Completion Date : | February 27, 2023 |
| Estimated Study Completion Date : | February 28, 2023 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
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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])
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Drug: BMS-813160
Specified dose on specified days Drug: 5-fluorouracil (5-FU) Specified dose on specified days Drug: Leucovorin Specified dose on specified days Drug: Irinotecan Specified dose on specified days |
| Experimental: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel |
Drug: BMS-813160
Specified dose on specified days Drug: Nab-paclitaxel Specified dose on specified days Drug: Gemcitabine Specified dose on specified days |
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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
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Drug: BMS-813160
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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| Experimental: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI |
Drug: BMS-813160
Specified dose on specified days Drug: 5-fluorouracil (5-FU) Specified dose on specified days Drug: Leucovorin Specified dose on specified days Drug: Irinotecan Specified dose on specified days |
| Experimental: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI |
Drug: BMS-813160
Specified dose on specified days Drug: 5-fluorouracil (5-FU) Specified dose on specified days Drug: Leucovorin Specified dose on specified days Drug: Irinotecan Specified dose on specified days |
| Experimental: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI |
Drug: 5-fluorouracil (5-FU)
Specified dose on specified days Drug: Leucovorin Specified dose on specified days Drug: Irinotecan Specified dose on specified days |
| Experimental: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel |
Drug: BMS-813160
Specified dose on specified days Drug: Nab-paclitaxel Specified dose on specified days Drug: Gemcitabine Specified dose on specified days |
| Experimental: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel |
Drug: BMS-813160
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Drug: Nab-paclitaxel Specified dose on specified days Drug: Gemcitabine Specified dose on specified days |
| Experimental: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel |
Drug: Nab-paclitaxel
Specified dose on specified days Drug: Gemcitabine Specified dose on specified days |
| Experimental: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab |
Drug: BMS-813160
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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| Experimental: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab |
Drug: BMS-813160
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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| Experimental: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy |
Drug: BMS-813160
Specified dose on specified days |
| Experimental: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy |
Drug: BMS-813160
Specified dose on specified days |
Primary Outcome Measures :
- Incidence of Adverse events (AEs) [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of Serious adverse events (SAEs) [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria [ Time Frame: Approximately 6 months ]Part 1 only
- Incidence of AEs leading to discontinuation [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of Death [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Approximately 4 years ]Part 1 only PR interval: The time from the onset of the P wave to the start of the QRS complex
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Approximately 4 years ]Part 1 only QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Approximately 4 years ]Part 1 only QT interval: Measured from the beginning of the QRS complex to the end of the T wave
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Approximately 4 years ]Part 1 only QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
- Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of clinically significant changes in vital signs: Pulse oximetry [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Approximately 4 years ]Part 1 only
- Decrease in regulatory T cells (Treg) or tumor-associated macrophage (TAM) in tumor samples [ Time Frame: Approximately 4 years ]Part 1 only
- Overall response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 2 years ]Part 2 only
- Median duration of response (DOR) [ Time Frame: Approximately 2 years ]Part 2 only
- Progression free survival (PFS) rate [ Time Frame: At 24 weeks ]Part 2 only
Secondary Outcome Measures :
- Overall response rate (ORR) [ Time Frame: Approximately 2 years ]Part 1 only
- Median duration of response (DOR) [ Time Frame: Approximately 2 years ]Part 1 only
- Progression free survival (PFS) rate [ Time Frame: At 24 weeks ]Part 1 only
- Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 4 years ]Part 1 only
- Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 4 years ]Part 1 only
- Trough observed plasma concentration (Ctrough) [ Time Frame: Approximately 4 years ]Part 1 only
- Observed plasma concentration at 24 hours post dose (C24) [ Time Frame: Approximately 4 years ]Part 1 only
- Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)] [ Time Frame: Approximately 4 years ]Part 1 only
- Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)] [ Time Frame: Approximately 4 years ]Part 1 only
- Apparent total body clearance (CLT/F) [ Time Frame: Approximately 4 years ]Part 1 only
- Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI) [ Time Frame: Approximately 4 years ]Part 1 only
- Renal clearance (CLR) [ Time Frame: Approximately 4 years ]Part 1 only
- Percent urinary recovery over 24 hours corrected for molecular weight (%UR) [ Time Frame: Approximately 4 years ]Part 1 only
- Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax) [ Time Frame: Approximately 4 years ]Part 1 only
- Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)] [ Time Frame: Approximately 4 years ]Part 1 only
- Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy [ Time Frame: Approximately 4 years ]Part 1 only
- Incidence of Adverse events (AEs) [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of Serious adverse events (SAEs) [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of AEs leading to discontinuation [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of Death [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria [ Time Frame: Approximately 6 months ]Part 2 Cohort 3b only
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of clinically significant changes in vital signs: Pulse oximetry [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Approximately 4 years ]Part 2 only
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Approximately 4 years ]Part 2 only PR interval: The time from the onset of the P wave to the start of the QRS complex
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Approximately 4 years ]Part 2 only QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Approximately 4 years ]Part 2 only QT interval: Measured from the beginning of the QRS complex to the end of the T wave
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Approximately 4 years ]Part 2 only QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
- Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples [ Time Frame: Approximately 4 years ]Part 2 only
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184870
Locations
Show 40 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03184870 |
| Other Study ID Numbers: |
CV202-103 2017-001725-40 ( EudraCT Number ) |
| First Posted: | June 14, 2017 Key Record Dates |
| Last Update Posted: | April 20, 2021 |
| Last Verified: | April 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Leucovorin Gemcitabine Paclitaxel Fluorouracil Nivolumab Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents |
Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors Topoisomerase I Inhibitors Topoisomerase Inhibitors Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients |