Universal Immunization to Fortify Immunotherapy Efficacy and Response
Public ClinicalTrials.gov record NCT07597070. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Universal Immunization to Fortify Immunotherapy Efficacy and Response (UNIFIER)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Although immune checkpoint inhibitors (ICIs) have substantially extended survival in many patients, most patients do not achieve durable responses on these treatments. There is a substantial unmet need for methods to sensitize more patients to ICIs. Studies have shown that personalized mRNA lipid nanoparticle vaccines enhance antitumor immunity in combination with PD1 inhibition, under the assumption that these vaccines generate T cells reactive against the targets encoded by the mRNA in the vaccines. However, it was recently found that mRNA vaccines targeting non-tumor antigens are also powerful adjuvants to immune checkpoint blockade. Retrospective clinical data strongly suggests that receipt of COVID mRNA vaccines with ICIs is responsible for significant improvements in three-year overall survival in multiple large cohorts of patients with non-small cell lung cancer (NSCLC). Patients treated with these vaccines also have increased expression of programmed death ligand 1 (PD-L1) on their tumors. This trial is designed to evaluate whether the Pfizer-BioNTech COVID mRNA vaccine improves responses to ICIs in patients with stage IV non-small cell lung cancer.
Study identification
- NCT ID
- NCT07597070
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 500 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2026 (Estimated)
- Primary completion
- Mar 2035 (Estimated)
- Completion
- Mar 2035 (Estimated)
- Last update posted
- Nov 2, 2026
2026 – 2035
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07597070, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2026 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07597070 live on ClinicalTrials.gov.