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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03184870
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Design
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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 : December 10, 2020
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination Therapy 1
BMS-813160 with 5-fluorouracil (5-FU), leucovorin containing regimens in combination with irinotecan
 Drug: BMS-813160
specified dose on specified days

Drug: 5-fluorouracil (5-FU)
chemotherapy regimen

Drug: Leucovorin
chemotherapy regimen

Drug: Irinotecan
chemotherapy regimen
Experimental: Combination Therapy 2
BMS-813160, nab/paclitaxel and gemcitabine
 Drug: BMS-813160
specified dose on specified days

Drug: Nab-paclitaxel
chemotherapy regimen

Drug: Gemcitabine
chemotherapy regimen
Experimental: Combination Therapy 3
BMS-813160 and Nivolumab
 Drug: BMS-813160
specified dose on specified days

Biological: Nivolumab
specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Combination Therapy 4
BMS-813160, nab/paclitaxel + gemcitabine, and Nivolumab
 Drug: BMS-813160
specified dose on specified days
Experimental: Combination Therapy 5
5-fluorouracil (5-FU), leucovorin containing regimens in combination with irinotecan
 Drug: 5-fluorouracil (5-FU)
chemotherapy regimen

Drug: Leucovorin
chemotherapy regimen

Drug: Irinotecan
chemotherapy regimen
Experimental: Combination Therapy 6
Nab/paclitaxel and gemcitabine
 Drug: Nab-paclitaxel
chemotherapy regimen

Drug: Gemcitabine
chemotherapy regimen
Experimental: Monotherapy
BMS-813160
 Drug: BMS-813160
specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Approximately 4 years ]
    Measured by incidence of AEs

  2. Serious adverse events (SAEs) [ Time Frame: Approximately 4 years ]
    Measured by incidence of SAEs

  3. 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

  4. AEs leading to discontinuation [ Time Frame: Approximately 4 years ]
    Measured by incidence of AEs leading to discontinuation

  5. Death [ Time Frame: Approximately 4 years ]
    Measured by incidence of deaths

  6. 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

  7. 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.

  8. Summary measures of vital signs [ Time Frame: Approximately 4 years ]
    Including weight, body temperature, respiratory rate, pulse oximetry, seated blood pressure and heart rate.

  9. 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.

  10. 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.

  11. 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.

  12. 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 :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation

  2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 4 years ]
    Summary statistics: medians and ranges

  3. 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

  4. Observed plasma concentration at 24 hours post dose (C24) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation

  5. 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

  6. 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

  7. Apparent total body clearance (CLT/F) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation

  8. 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

  9. Renal clearance (CLR) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation

  10. Percent urinary recovery over 24 hours corrected for molecular weight (%UR) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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.


Eligibility Criteria
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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.


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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

Contacts and Locations
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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
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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
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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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: November 29, 2019
Last Verified: November 2019

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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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Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Nivolumab
Irinotecan
Fluorouracil
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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors