A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
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| ClinicalTrials.gov Identifier: NCT03184870 |
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Recruitment Status :
Recruiting
First Posted : June 14, 2017
Last Update Posted : August 19, 2020
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or 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) |
| Estimated Enrollment : | 348 participants |
| Allocation: | Non-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 4, 2017 |
| Estimated Primary Completion Date : | January 10, 2022 |
| Estimated Study Completion Date : | February 23, 2023 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Combination Therapy 1
BMS-813160 with 5-fluorouracil (5-FU), leucovorin containing regimens in combination with irinotecan
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Drug: BMS-813160
specified dose on specified days Drug: 5-fluorouracil (5-FU) chemotherapy regimen Drug: Leucovorin chemotherapy regimen Drug: Irinotecan chemotherapy regimen |
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Experimental: Combination Therapy 2
BMS-813160, nab/paclitaxel and gemcitabine
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Drug: BMS-813160
specified dose on specified days Drug: Nab-paclitaxel chemotherapy regimen Drug: Gemcitabine chemotherapy regimen |
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Experimental: Combination Therapy 3
BMS-813160 and Nivolumab
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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: Combination Therapy 4
BMS-813160, nab/paclitaxel + gemcitabine, and Nivolumab
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Drug: BMS-813160
specified dose on specified days |
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Experimental: Combination Therapy 5
5-fluorouracil (5-FU), leucovorin containing regimens in combination with irinotecan
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Drug: 5-fluorouracil (5-FU)
chemotherapy regimen Drug: Leucovorin chemotherapy regimen Drug: Irinotecan chemotherapy regimen |
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Experimental: Combination Therapy 6
Nab/paclitaxel and gemcitabine
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Drug: Nab-paclitaxel
chemotherapy regimen Drug: Gemcitabine chemotherapy regimen |
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Experimental: Monotherapy
BMS-813160
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Drug: BMS-813160
specified dose on specified days |
Primary Outcome Measures :
- Adverse events (AEs) [ Time Frame: Approximately 4 years ]Measured by incidence of AEs
- Serious adverse events (SAEs) [ Time Frame: Approximately 4 years ]Measured by incidence of SAEs
- AEs meeting protocol-defined dose limiting toxicity criteria [ Time Frame: Approximately 6 months ]Measured by incidence of AEs that meet the protocol-defined dose limiting toxicity criteria
- AEs leading to discontinuation [ Time Frame: Approximately 4 years ]Measured by incidence of AEs leading to discontinuation
- Death [ Time Frame: Approximately 4 years ]Measured by incidence of deaths
- Incidence of laboratory abnormalities [ Time Frame: Approximately 4 years ]Measured by any laboratory test result that is clinically significant or meets the definition of an SAE, any laboratory test result abnormality that required the patient to have study treatment discontinued or interrupted, or any laboratory test result abnormality that required the participant to receive specific corrective therapy
- Electrocardiogram (ECG) [ Time Frame: Approximately 4 years ]ECGs will be evaluated by the investigator for any clinically significant changes or for changes meeting dose modifying criteria.
- Summary measures of vital signs [ Time Frame: Approximately 4 years ]Including weight, body temperature, respiratory rate, pulse oximetry, seated blood pressure and heart rate.
- Overall response rate (ORR) [ Time Frame: Approximately 2 years ]Part 2 Only: ORR is defined as the proportion of all treated participants whose Best overall response (BOR) is either complete response or partial response. BOR for a participant will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator.
- Median duration of response (DOR) [ Time Frame: Approximately 2 years ]Part 2 Only: DOR for a participant with a BOR of CR or PR, is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first.
- Progression free survival (PFS) rate [ Time Frame: At 24 weeks ]Part 2 Only: PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
- Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples [ Time Frame: Approximately 4 years ]Part 1 Only: Examination of tumor-associated immune cells and microenvironment, through proteomics.
Secondary Outcome Measures :
- Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 4 years ]Summary statistics: medians and ranges
- Trough observed plasma concentration (Ctrough) [ Time Frame: Approximately 4 years ]Summary statistics to assess attainment of steady state: geometric means and coefficients of variation; plots vs time by dose
- Observed plasma concentration at 24 hours post dose (C24) [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)] [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)] [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- Apparent total body clearance (CLT/F) [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- 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 ]Summary statistics: geometric means and coefficients of variation
- Renal clearance (CLR) [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- Percent urinary recovery over 24 hours corrected for molecular weight (%UR) [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax) [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)] [ Time Frame: Approximately 4 years ]Summary statistics: geometric means and coefficients of variation
- Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy [ Time Frame: Approximately 4 years ]Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment
- Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples [ Time Frame: Approximately 4 years ]Part 2 Only: Examination of tumor-associated immune cells and microenvironment, through proteomics.
- Overall response rate (ORR) [ Time Frame: Approximately 2 years ]Part 1 Only: ORR is defined as the proportion of all treated participants whose Best overall response (BOR) is either complete response or partial response. BOR for a participant will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator.
- Median duration of response (DOR) [ Time Frame: Approximately 2 years ]Part 1 Only: DOR for a participant with a BOR of CR or PR, is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first
- Progression free survival (PFS) rate [ Time Frame: Approximately 2 years ]Part 1 Only: PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
Information from the National Library of Medicine
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| 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:
- Participants must have metastatic colorectal or pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Ability to swallow pills or capsules
- All participants will be required to undergo mandatory pre and on-treatment biopsies
- Adequate marrow function
- Adequate other organ functions
- Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up
Exclusion Criteria:
- Histology other than adenocarcinoma (neuroendocrine or acinar cell)
- Suspected, known, or progressive CNS metastases (Imaging required only if participants are symptomatic)
- Participants with active, known or suspected autoimmune disease
- Participants with a 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 CCR2 and/or CCR5 inhibitors, PD-1, PD(L)-1 or 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 could 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
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information. | please email: | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain NCT # and Site #. |
Locations
Show 53 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: | August 19, 2020 |
| Last Verified: | August 2020 |
| 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 Irinotecan Nivolumab 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 Topoisomerase I Inhibitors Topoisomerase Inhibitors Antineoplastic Agents, Immunological Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances |