Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy) 2. 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 3. Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months 4. No known presence of the specific ALK acquired resistance alterations targeted by the stu…
Interventions
- BiologicalPeptide vaccine
Peptide vaccine
Location
- Johns Hopkins UniversityBaltimore, Maryland