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Universal Immunization to Fortify Immunotherapy Efficacy and Response

NCT07597070 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-05-19

No results posted yet for this study

Summary

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) and metastatic melanoma. 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 immune checkpoint inhibitors in patients with stage IV melanoma and stage IV non-small cell lung cancer.

Conditions

  • Stage 4 NSCLC
  • Melanoma (Skin) Stage IV

Interventions

BIOLOGICAL

Pfizer-BioNTech mRNA COVID-19 vaccine

Participants will receive a Pfizer-BioNTech COVID-19 mRNA vaccine within 7 days before initiating their immune checkpoint inhibitor therapy. Participants will receive the mRNA COVID-19 vaccine at their local pharmacy and this vaccine will not be provided by the study site. The vaccine is expected to change during the study. Participants will obtain the most up-to-date Pfizer COVID-19 mRNA vaccine available for which they qualify under standard of care.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Elias Sayour, MD, PhD · University of Florida

  • Steven Lin, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2035-03-31
Completion
2035-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07597070 on ClinicalTrials.gov