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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
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.
Incidence of immune-related adverse events requiring hospitalization
Determine the incidence for randomized subjects of immune response adverse events requiring hospitalization within 60 days of starting planned treatment with pembrolizumab and chemotherapy.
Time frame: 60 days after the start of treatment with pembrolizumab and chemotherapy
Progression-free survival
Determine the progression-free survival among all randomized subjects. Progression-free survival is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first.
Time frame: 5 years
Progression-free survival
Determine the progression-free survival among randomized subjects receiving first line of immune checkpoint inhibitor therapy without brain metastases. Progression-free survival is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first.
Time frame: 5 years
Progression-free survival
Determine the progression-free survival among randomized subjects receiving combination PD-1 and CTLA-4 directed immune checkpoint inhibitor therapy. Progression-free survival is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first.
Time frame: 5 years
Change in tumor proportion score
Determine the change in tumor proportion score within 100 days of receiving Pfizer-BioNTech COVID mRNA vaccine among randomized patients with biopsy obtained as standard of care.
Time frame: 100 days after receipt of Pfizer-BioNTech COVID mRNA vaccine
Feasibility of administering COVID-19 mRNA vaccine within 7 days prior to initiating immune checkpoint inhibitor therapy
Determine the percentage of randomized subjects who experience a delay related to vaccine in starting immune checkpoint inhibitor therapy after receiving COVID-19 mRNA vaccine. A subject is considered to experienced a delay if immune checkpoint inhibitor therapy is started 14 days or more after randomization.
Time frame: 14 days after randomization
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