NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trial
I the proliferation of intra-tumour CD8+ T cells is directly correlated with the clinical response, making tumour-infiltrating lymphocytes (TILs) a treatment of interest in combination with a PD-1 inhibitor, which is the undisputed gold standard in the management of metastatic melanoma. The aim of...
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Medical Journals Sweden
2024-11-01
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| Series: | Acta Oncologica |
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| Online Access: | https://medicaljournalssweden.se/actaoncologica/article/view/40495 |
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| author | Jean-Matthieu L'Orphelin Ugo Lancien Jean-Michel Nguyen Francisco J.S. Coronilla Soraya Saiagh Julie Cassecuel Lise Boussemart Anne Dompmartin Brigitte Dréno |
| author_facet | Jean-Matthieu L'Orphelin Ugo Lancien Jean-Michel Nguyen Francisco J.S. Coronilla Soraya Saiagh Julie Cassecuel Lise Boussemart Anne Dompmartin Brigitte Dréno |
| author_sort | Jean-Matthieu L'Orphelin |
| collection | DOAJ |
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I
the proliferation of intra-tumour CD8+ T cells is directly correlated with the clinical response, making tumour-infiltrating lymphocytes (TILs) a treatment of interest in combination with a PD-1 inhibitor, which is the undisputed gold standard in the management of metastatic melanoma. The aim of this trial was, therefore, to evaluate the safety and efficacy of sequential combination therapy consisting of nivolumab (a PD-1 inhibitor) and TILs adoptive T cells in patients with metastatic melanoma.
Materials and methods: We performed an exploratory, prospective, single-centre, open-label, non-randomised, uncontrolled phase I/II study. We enrolled 10 previously untreated patients with advanced melanoma. The treatment regimen was neoadjuvant anti-PD-1 therapy followed by 2 injections of TILs and a second sequence of anti-PD-1 therapy.
Results and interpretation: Among the four patients who received the autologous TILs + nivolumab combination, three (75%) achieved an objective response (two achieved a partial response [PR] at the end of the study, two achieved a complete response [CR]), and one achieved a CR at the end of the study. Among these three patients, one had a PR, and two had stable disease (SD) after the nivolumab course and before any TILs administration, reinforcing the importance of the tumour response after TILs injection. These responses were persistent, ranging from 9 months to 3.4 years.
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| format | Article |
| id | doaj-art-c7cd105e11d84339991d65c0b7cdb318 |
| institution | OA Journals |
| issn | 1651-226X |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Medical Journals Sweden |
| record_format | Article |
| series | Acta Oncologica |
| spelling | doaj-art-c7cd105e11d84339991d65c0b7cdb3182025-08-20T02:12:45ZengMedical Journals SwedenActa Oncologica1651-226X2024-11-0163110.2340/1651-226X.2024.40495NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trialJean-Matthieu L'Orphelin0https://orcid.org/0000-0002-5680-7888Ugo Lancien 1https://orcid.org/0000-0003-1262-5510Jean-Michel Nguyen 2https://orcid.org/0000-0001-8815-7640Francisco J.S. Coronilla3Soraya Saiagh 4Julie Cassecuel 5Lise Boussemart6https://orcid.org/0000-0002-6895-0139Anne Dompmartin 7https://orcid.org/0000-0003-0081-500XBrigitte Dréno 8https://orcid.org/0000-0001-5574-58251Department of Dermatology, Caen-Normandie University Hospital, Caen, France; Interdisciplinary Research Unit for Cancer Prevention and Treatment, Université de Caen Normandie Inserm Anticipe UMR 1086, Normandie Univ, Research Building, Caen, FrancDepartment of Plastic Surgery, Nantes University Hospital, Nantes, FranceNantes – Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, FranceNantes – Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, FranceNantes – Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, FranceNantes – Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, FranceNantes – Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, FranceDepartment of Dermatology, Caen-Normandie University Hospital, Caen, FranceNantes – Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, France I the proliferation of intra-tumour CD8+ T cells is directly correlated with the clinical response, making tumour-infiltrating lymphocytes (TILs) a treatment of interest in combination with a PD-1 inhibitor, which is the undisputed gold standard in the management of metastatic melanoma. The aim of this trial was, therefore, to evaluate the safety and efficacy of sequential combination therapy consisting of nivolumab (a PD-1 inhibitor) and TILs adoptive T cells in patients with metastatic melanoma. Materials and methods: We performed an exploratory, prospective, single-centre, open-label, non-randomised, uncontrolled phase I/II study. We enrolled 10 previously untreated patients with advanced melanoma. The treatment regimen was neoadjuvant anti-PD-1 therapy followed by 2 injections of TILs and a second sequence of anti-PD-1 therapy. Results and interpretation: Among the four patients who received the autologous TILs + nivolumab combination, three (75%) achieved an objective response (two achieved a partial response [PR] at the end of the study, two achieved a complete response [CR]), and one achieved a CR at the end of the study. Among these three patients, one had a PR, and two had stable disease (SD) after the nivolumab course and before any TILs administration, reinforcing the importance of the tumour response after TILs injection. These responses were persistent, ranging from 9 months to 3.4 years. https://medicaljournalssweden.se/actaoncologica/article/view/40495ImmunotherapyImmunotherapy Anti-PD-1TILsAdoptive cell transfermelanoma |
| spellingShingle | Jean-Matthieu L'Orphelin Ugo Lancien Jean-Michel Nguyen Francisco J.S. Coronilla Soraya Saiagh Julie Cassecuel Lise Boussemart Anne Dompmartin Brigitte Dréno NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trial Acta Oncologica Immunotherapy Immunotherapy Anti-PD-1 TILs Adoptive cell transfer melanoma |
| title | NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trial |
| title_full | NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trial |
| title_fullStr | NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trial |
| title_full_unstemmed | NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trial |
| title_short | NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trial |
| title_sort | nivo til combination anti pd 1 therapy and adoptive t cell transfer in untreated metastatic melanoma an exploratory open label phase i trial |
| topic | Immunotherapy Immunotherapy Anti-PD-1 TILs Adoptive cell transfer melanoma |
| url | https://medicaljournalssweden.se/actaoncologica/article/view/40495 |
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