Clinical Trials /

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

NCT03184870

Description:

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.

Related Conditions:
  • Colorectal Adenocarcinoma
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CV202-103
  • SECONDARY ID: 2017-001725-40
  • NCT ID: NCT03184870

Conditions

  • Colorectal Cancer
  • Pancreatic Cancer

Interventions

DrugSynonymsArms
BMS-813160Combination Therapy 1
NivolumabOpdivo, BMS-936558Combination Therapy 3
Nab-paclitaxelCombination Therapy 2
GemcitabineCombination Therapy 2
5-fluorouracil (5-FU)Combination Therapy 1
LeucovorinCombination Therapy 1
IrinotecanCombination Therapy 1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Combination Therapy 1ExperimentalBMS-813160 with 5-fluorouracil (5-FU), leucovorin containing regimens in combination with irinotecan
  • BMS-813160
  • 5-fluorouracil (5-FU)
  • Leucovorin
  • Irinotecan
Combination Therapy 2ExperimentalBMS-813160, nab/paclitaxel and gemcitabine
  • BMS-813160
  • Nab-paclitaxel
  • Gemcitabine
Combination Therapy 3ExperimentalBMS-813160 and Nivolumab
  • BMS-813160
  • Nivolumab
Combination Therapy 4ExperimentalBMS-813160, nab/paclitaxel + gemcitabine, and Nivolumab
  • BMS-813160
Combination Therapy 5Experimental5-fluorouracil (5-FU), leucovorin containing regimens in combination with irinotecan
  • 5-fluorouracil (5-FU)
  • Leucovorin
  • Irinotecan
Combination Therapy 6ExperimentalNab/paclitaxel and gemcitabine
  • Nab-paclitaxel
  • Gemcitabine
MonotherapyExperimentalBMS-813160
  • BMS-813160

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events (AEs)
Time Frame:Approximately 4 years
Safety Issue:
Description:Measured by incidence of AEs

Secondary Outcome Measures

Measure:Maximum observed plasma concentration (Cmax)
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Time of maximum observed plasma concentration (Tmax)
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: medians and ranges
Measure:Trough observed plasma concentration (Ctrough)
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics to assess attainment of steady state: geometric means and coefficients of variation; plots vs time by dose
Measure:Observed plasma concentration at 24 hours post dose (C24)
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)]
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)]
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Apparent total body clearance (CLT/F)
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure: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
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Renal clearance (CLR)
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Percent urinary recovery over 24 hours corrected for molecular weight (%UR)
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax)
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)]
Time Frame:Approximately 4 years
Safety Issue:
Description:Summary statistics: geometric means and coefficients of variation
Measure:Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy
Time Frame:Approximately 4 years
Safety Issue:
Description:Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment
Measure:Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples
Time Frame:Approximately 4 years
Safety Issue:
Description:Part 2 Only: Examination of tumor-associated immune cells and microenvironment, through proteomics.
Measure:Overall response rate (ORR)
Time Frame:Approximately 2 years
Safety Issue:
Description: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.
Measure:Median duration of response (DOR)
Time Frame:Approximately 2 years
Safety Issue:
Description: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
Measure:Progression free survival (PFS) rate
Time Frame:Approximately 2 years
Safety Issue:
Description: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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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