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CompletedPhase 2NCT01909752
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCyclophosphamide and DRibble vaccine

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 6, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?UbiVac

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
UbiVac
Interventions being studied
Drug: Cyclophosphamide; Biological: DRibble vaccine; Drug: Imiquimod; Drug: GM-CSF; Biological: HPV vaccine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • LSU Stanley S. Scott Cancer CenterNew Orleans, Louisiana
  • Providence Cancer CenterPortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2017. Always confirm current availability with the study team.

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