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

Overview

About this study

This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria: 

  • Participants must have measurable disease by RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Ability to swallow tablets or capsules.
  • All participants will be required to undergo mandatory pre and on-treatment biopsies. If a participant had a biopsy in the preceding 90 days with no intervening anti-cancer therapy, participants can be enrolled without needing a repeat biopsy after discussion with the Medical Monitor and availability of FFPE blocks or unstained slides as delineated below.  Participants will however be required to undergo on-treatment biopsy at acceptable clinical risk as judged by the investigator in all arms.
    • Pre-treatment tissue must be collected and centrally or locally confirmed for adequate tissue quantity and quality during the screening period prior to first dose of study treatment. Please refer to lab manual for detailed biopsy collection instructions. Up to 5 participants per cohort may be allowed before confirmation of adequate tissue after discussion with the Medical Monitor.
    • The tumor tissue specimen must be a core needle biopsy, excisional or incisional biopsy. Fine needle biopsies, drainage of pleural effusions with cytospins, or punch biopsies are not considered adequate for biomarker review. Biopsies of bone lesions that do not have a soft tissue component or decalcified bone tumor samples are also not acceptable. Where possible, the biopsied lesion should be distinct from target lesions being evaluated for radiologic response, and the same lesion should be used for both the baseline and on-treatment sampling.
  • Adequate marrow function as defined by the following:
    • White blood cell (WBC) ≥ 2000/µL; > 1500/ µL allowed for Arms C and D
    • Neutrophils  ≥ 1500/µL; > 1000/µL allowed for Arms C and D
    • Platelets  ≥ 100 x 103/µL; > 75,000/µL allowed for Arms C and D
    • Hemoglobin  ≥ 8.5 g/dL
  • Adequate other organ functions as defined by the following:
    • Alanine aminotransferase (ALT) and (aspartate aminotransferase) AST ≤ 3x institutional upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5x institutional ULN (except participants with Gilbert’s Syndrome who must have normal direct bilirubin)
    • Serum creatinine ≤ 1.5x ULN or creatinine clearance (CrCl)  ≥ 40 mL/min (measured using the Cockcroft-Gault formula below):
  • Female CrCl = (140 − ... in years) × weight in kg × 0.85
                             72 × serum creatinine in mg/dL
  • Male CrCl = (140 − age in years) × weight in kg × 1.00
                          72 × serum creatinine in mg/dL
  • Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up.

Age and Reproductive Status

  • Males and females, age 18 years or age of majority or older at the time of consent.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment.
  • Women must not be breastfeeding.
  • Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatments BMS-813160 plus 5 half-lives of study treatment plus 30 days (duration of ovulatory cycle) for a total of 5 months post-treatment completion.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatments BMS-813160 plus 5 half-lives of the study treatment plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.
  • Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.
  • Investigators shall counsel WOCBP, and male participants who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
  • Investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of < 1% when used consistently and correctly.

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.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Wen Wee Ma, M.B.B.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions