Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.

Key facts

Study ID

NCT01909752

Run by

UbiVac

People needed

12

Starts

2013-07-01

Expected to finish

2017-04-01

Last updated by the study team

2017-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage IIIA or IIIB histologically proven non-small cell lung cancer
• Completion of definitive therapy
• Enrollment from 28 days to 12 weeks from completion of definitive therapy
• Toxicities from definitive therapy resolved to less than grade 1
• ECOG performance status 0-1
• Negative pregnancy test in women of childbearing potential
• Agree to avoid pregnancy or fathering a child while on study treatment
• Ability to give informed consent and comply with protocol
• Anticipated survival minimum of 6 months
• Prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment
• Normal organ and marrow function as defined by specific lab tests
• Archived tumor tissue available

You may not qualify if…

• Active autoimmune disease except for vitilogo or hypothyroidism
• Active other malignancy
• Known HIV+ and/or Hepatitis B or C positive
• Medical or psychiatric conditions that would preclude safe participation
• Ongoing chemotherapy

Where it is running

• LSU Stanley S. Scott Cancer Center — New Orleans, Louisiana, United States
• Providence Cancer Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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