TG4010 and Nivolumab in Patients With Lung Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Megan Daly, MD
Study ID
NCT02823990
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage I Non-Small Cell Lung Cancer
  • Stage II Non-Small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • TG4010 — BIOLOGICAL
    Given SC
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies how well TG4010 and nivolumab work in previously treated patients with non-small cell lung cancer. Vaccines that are made from a gene-modified virus, such as TG4010, may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as nivolumab, interfere with the ability of tumor cells to grow and spread. Giving TG4010 and nivolumab together may work better in previously treated patients with non-small cell lung cancer.

Key Dates

Start date
Dec 14, 2016
Status verified
Oct 2025
Primary completion
Feb 24, 2021
Completion
Feb 24, 2021

Study Design

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

Arms

  • Experimental: Treatment TG4010 + nivolumab
    Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

ORR Defined as the Proportion of Patients Whose Best Overall Response (BOR) is Either Complete Response (CR) or Partial Response (PR) According to RECIST 1.1 [ Time Frame: Up to 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of California San DiegoSan DiegoCalifornia92103-
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of California San Diego· San Diego, CAUCSF Medical Center-Mount Zion· San Francisco, CA

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