The purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.
Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry (IHC), (3) tissue next-generation sequencing (NGS), or (4) circulating tumor DNA (ctDNA) NGS
Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months
No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine
Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed.
Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine
Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine
Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
Single group
Peptide vaccine
Biological/VaccinePeptide vaccine
Incidence of treatment-related adverse events
The safety of administering the ALK peptide vaccine will be assessed by the occurrence of the following adverse events: * Grade 3 or above drug-related toxicities * Drug-related toxicity by grade * Vaccine site reactions after vaccine injections * Immune-related adverse events (AEs) * Unacceptable toxicities * Treatment-emergent changes from normal to abnormal values in key laboratory parameters
Vaccine-specific immune response
Vaccine-specific response will be evaluated by the fold change in interferon-producing mutant-ALK-specific CD8 and CD4 T cells in the peripheral blood.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Oncovir, Inc.
Collaborator
