Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT03061188
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Neoplasm
  • Aggressive Non-Hodgkin Lymphoma
  • Recurrent Solid Neoplasm
  • Refractory Mantle Cell Lymphoma
  • T-Cell Non-Hodgkin Lymphoma
  • Unresectable Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Pharmacological Study — OTHER
    Correlative studies
  • Veliparib — DRUG
    Given PO

Study Details

The purpose of this research study is to determine the highest and safest dose of the experimental drug veliparib when combined with nivolumab. We will also study how safely this combination of medication can be given in advanced cancer and lymphoma and benefits of receiving this therapy. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer. Veliparib is not yet approved for use in the United States, and is considered experimental. Veliparib inhibits (blocks) the activity of the enzyme PARP. This blocking activity may prevent the cancer cell from repairing itself and resume growing. Nivolumab increases T cells in your immune system, which allows your immune system to attack the cancer. We think the combination of these drugs will be more effective against your cancer.

Key Dates

Start date
May 23, 2017
Status verified
May 2024
Primary completion
Mar 11, 2018
Completion
Aug 4, 2020

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (veliparib, nivolumab)
    Patients receive veliparib PO BID on day 1 and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: First Cycle of Treatment with velaparib and nivolumab (28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-

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By research site
Northwestern University· Chicago, IL

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