Multi-institutional, prospective, randomized, double-blind, placebo-controlled phase IIb trial of the tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine to prevent recurrence in high-risk melanoma patients: A subgroup analysis.
Robert Connor ChickMark B FariesDiane F HalePhillip M Kemp BohanAnnelies T HickersonTimothy J VreelandJohn W MyersJessica L CindassTommy A BrownJohn HyngstromAdam C BergerJames W JakubJeffrey J SussmanMontaser ShaheenG Travis CliftonHyohyun ParkAmanda J SloanThomas WagnerGeorge E PeoplesPublished in: Cancer medicine (2021)
The TLPLDC vaccine improved DFS in patients completing the primary vaccine series, particularly in the resected stage IV patients. The efficacy of the TLPLDC vaccine will be confirmed in a phase III study evaluating adjuvant TLPLDC + CPI versus Placebo + CPI in resected stage IV melanoma patients.
Keyphrases
- phase iii
- double blind
- placebo controlled
- end stage renal disease
- ejection fraction
- chronic kidney disease
- prognostic factors
- newly diagnosed
- open label
- dendritic cells
- peritoneal dialysis
- randomized controlled trial
- phase ii
- lymph node
- study protocol
- immune response
- drug delivery
- patient reported outcomes
- phase ii study