PT - JOURNAL ARTICLE AU - Chantal Saberian AU - Rodabe N. Amaria AU - Amer M. Najjar AU - Laszlo G. Radvanyi AU - Cara L. Haymaker AU - Marie-Andrée Forget AU - Roland L. Bassett AU - Silvana C. Faria AU - Isabella C. Glitza AU - Enrique Alvarez AU - Sapna Parshottam AU - Victor Prieto AU - Gregory Lizée AU - Michael K. Wong AU - Jennifer L. McQuade AU - Adi Diab AU - Cassian Yee AU - Hussein A. Tawbi AU - Sapna Patel AU - Elizabeth J. Shpall AU - Michael A. Davies AU - Patrick Hwu AU - Chantale Bernatchez TI - 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 AID - 10.1136/jitc-2021-002449 DP - 2021 May 01 TA - Journal for ImmunoTherapy of Cancer PG - e002449 VI - 9 IP - 5 4099 - http://jitc.bmj.com/content/9/5/e002449.short 4100 - http://jitc.bmj.com/content/9/5/e002449.full SO - J Immunother Cancer2021 May 01; 9 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.