Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT03525925
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies how well ibrutinib and nivolumab work in treating participants with solid tumors that have spread to other places in the body. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib and nivolumab may work better in treating participants with solid tumors.

Key Dates

Start date
Jul 18, 2018
Status verified
Mar 2024
Primary completion
Feb 20, 2020
Completion
Jul 31, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibrutinib, nivolumab)
    Participants receive ibrutinib PO daily for 15 days. After 7 days receiving ibrutinib, participants receive nivolumab IV over 60 minutes on days 1 and 15. Courses with nivolumab repeat every 28 days in the absence of disease progression or unaccepted toxicity.

Primary Outcome Measure

Circulating levels of myeloid derived suppressor cells [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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