RT Journal Article SR Electronic T1 Randomized phase II trial of lymphodepletion plus adoptive cell transfer of tumor-infiltrating lymphocytes, with or without dendritic cell vaccination, in patients with metastatic melanoma JF Journal for ImmunoTherapy of Cancer JO J Immunother Cancer FD BMJ Publishing Group Ltd SP e002449 DO 10.1136/jitc-2021-002449 VO 9 IS 5 A1 Chantal Saberian A1 Rodabe N. Amaria A1 Amer M. Najjar A1 Laszlo G. Radvanyi A1 Cara L. Haymaker A1 Marie-Andrée Forget A1 Roland L. Bassett A1 Silvana C. Faria A1 Isabella C. Glitza A1 Enrique Alvarez A1 Sapna Parshottam A1 Victor Prieto A1 Gregory Lizée A1 Michael K. Wong A1 Jennifer L. McQuade A1 Adi Diab A1 Cassian Yee A1 Hussein A. Tawbi A1 Sapna Patel A1 Elizabeth J. Shpall A1 Michael A. Davies A1 Patrick Hwu A1 Chantale Bernatchez YR 2021 UL http://jitc.bmj.com/content/9/5/e002449.abstract AB Background The adoptive transfer of tumor-infiltrating lymphocytes (TIL) has demonstrated robust efficacy in metastatic melanoma patients. Tumor antigen–loaded dendritic cells (DCs) are believed to optimally activate antigen-specific T lymphocytes. We hypothesized that the combined transfer of TIL, containing a melanoma antigen recognized by T cells 1 (MART-1) specific population, with MART-1-pulsed DC will result in enhanced proliferation and prolonged survival of transferred MART-1 specific T cells in vivo ultimately leading to improved clinical responses.Design We tested the combination of TIL and DC in a phase II clinical trial of patients with advanced stage IV melanoma. HLA-A0201 patients whose early TIL cultures demonstrated reactivity to MART-1 peptide were randomly assigned to receive TIL alone or TIL +DC pulsed with MART-1 peptide. The primary endpoint was to evaluate the persistence of MART-1 TIL in the two arms. Secondary endpoints were to evaluate clinical response and survival.Results Ten patients were given TIL alone while eight patients received TIL+DC vaccine. Infused MART-1 reactive CD8+ TIL were tracked in the blood over time by flow cytometry and results show good persistence in both arms, with no difference in the persistence of MART-1 between the two arms. The objective response rate was 30% (3/10) in the TIL arm and 50% (4/8) in the TIL+DC arm. All treatments were well tolerated.Conclusions The combination of TIL +DC showed no difference in the persistence of MART-1 TIL compared with TIL therapy alone. Although more patients showed a clinical response to TIL+DC therapy, this study was not powered to resolve differences between groups.Trial registration number NCT00338377.Data sharing not applicable as no datasets generated and/or anlayzed for this study. All data relevant to the study are included in the article or uploaded as online supplemental information.