Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembroliz… (NCT04266730) | Clinical Trial Compass
SuspendedPhase 1
Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab
Stopped: Not stated
United States6 participantsStarted 2027-05-20
Plain-language summary
This is a single center, open-label phase I clinical trial designed to determine the safety of personalized and adjusted neoantigen peptide vaccine (PANDA-VAC) administered concurrently with pembrolizumab in subjects with advanced squamous non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (SCCHN).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must sign an institutional review board (IRB) approved informed consent to undergo tissue procurement and HIPAA authorization for release of personal health information.
✓. Subject must have a previously treated, histologically confirmed squamous non-small cell lung cancer and head and neck squamous cell carcinoma where cure is either not possible or curative modality therapy is declined by the subject.
✓. Subject has adequate archival tumor tissue for sequencing for vaccine generation.
✓. Subject has Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
✓. Subject has adequate bone marrow function as demonstrated by:
✓. Subject has radiographically measurable according to RECIST 1.1 and iRECIST.
✓. Subjects must per RECIST 1.1 have stable disease, mixed response, oligoprogressive state (defined as disease progression at a limited number of anatomic sites, with continued response or stable disease at other sites of disease) or non-threatening progression (progression that fits a clinical pattern where the treating physician believes that PD-1 therapy post-progression is appropriate (e.g. multiple sub-centimeter nodules that do not compromise the bronchus)) on a PD-1, PDL-1 or PD-1/L containing regimen.
✓
What they're measuring
1
Number of adverse events in participants as a measure of safety of personalized and dose adjusted antitumor peptide vaccine (PANDA-VAC) administered concomitantly with pembrolizumab.
✕. Subject is currently participating in or has participated in a study of an investigational agent within 4 weeks of study pembrolizumab treatment initiation.
✕. Subject has active infection requiring systemic therapy.
✕. Subject is pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study).
✕. Subject has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least five years.
✕. Subject has active central nervous system (CNS) metastases. Treated metastases without evidence of progression will be allowed. Asymptomatic, subcentimeter metastases not requiring treatment will be allowed. Any leptomeningeal disease will be excluded.
✕. Subject is currently using systemic corticosteroids at doses ≥10mg prednisone daily or its equivalent, or other immunosuppressive medications including, but not limited to methotrexate, azathioprine, calcineurin inhibitor, and TNF-α blockers.
✕. Subject has known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
✕. Subject has a history of primary immunodeficiency.